<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01660412</url>
  </required_header>
  <id_info>
    <org_study_id>31337</org_study_id>
    <nct_id>NCT01660412</nct_id>
  </id_info>
  <brief_title>Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?</brief_title>
  <acronym>buffering SLN</acronym>
  <official_title>Does Alkalinization of Technetium-99m Sulfur Colloid Reduce Perceived Pain Levels During Non-breast Sentinel Lymphoscintigraphy?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Howard J Barnhard, Resident Research Endowment.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UAMS DEPT of Radiology.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arkansas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pain during nuclear medicine breast lymphnode detection procedures has been reported as high&#xD;
      as 8.8/10. Using Sodium Bicarbonate to alkalinize the radio-pharmaceutical injection, pain&#xD;
      can safely be reduced from 6.6/10 to 4.7/10, during breast lymph node detection procedures.&#xD;
&#xD;
      In sites other then the breast, using Bicarbonate to make the injection's pH closer to&#xD;
      natural, attempts to lower the pain levels will be performed.&#xD;
&#xD;
      Hypothesis: The perceived pain level during non breast sentinel lymph node techniques can be&#xD;
      reduced by raising the pH of the injectate (Tc-99m SC) to near the physiologic level of pH&#xD;
      7.40.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2012</start_date>
  <completion_date type="Actual">December 30, 2016</completion_date>
  <primary_completion_date type="Actual">December 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perceived Pain Level</measure>
    <time_frame>immediately after administration (&lt;1 min) of each injection (up to total 5 minutes)</time_frame>
    <description>Immediately after receiving an injection, subjects will rate their perceived pain level, using a validated measure. Subject was asked to quantify the pain of every injection using a validated scale from 0 through 10, with 0 being no pain and 10 being severe pain that is disabling. The effect of treatment was estimated by taking the difference of the mean buffered and SOC pain scores and a paired t-test was used to test whether the mean difference was significantly different from 0. Perceived pain levels assessed after each injection were averaged for each participant.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>pH altered first</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The first injection administered will be the pH altered solution. The second injection will be the standard of care solution (opposite order). The remaining injections will be randomly assigned as either standard of care or pH altered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care first</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The first injection administered will be the standard of care solution (SOC). The second injection will be the pH altered solution. The remaining injections will be randomly assigned as either standard of care or pH altered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of Care First</intervention_name>
    <description>For the second injection, and randomly after that, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40.</description>
    <arm_group_label>Standard of Care first</arm_group_label>
    <other_name>Sodium Bicarbonate second</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ph Altered first</intervention_name>
    <description>For the first injection, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40. For the second injection, the standard of care will be given, and randomly after that either standard of care, or pH altered will be given.</description>
    <arm_group_label>pH altered first</arm_group_label>
    <other_name>Sodium Bicarbonate first</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting for SLN imaging for melanoma or who have had an excisional biopsy&#xD;
             for melanoma of the thorax and appendicular structures;&#xD;
&#xD;
          -  Patients scheduled to receive two or more injections of Tc-99m SC for the purpose of&#xD;
             clinical management of melanoma or who have had an excisional biopsy for melanoma of&#xD;
             the thorax and appendicular structures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients presenting for SLN imaging of lesions involving the breast, ear, nose, and&#xD;
             genitourinary regions;&#xD;
&#xD;
          -  Patients scheduled to receive only a single injection of Tc-99m SC;&#xD;
&#xD;
          -  Pregnant or breast feeding women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>122 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James A Ntambi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UAMS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UAMS</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Fetzer S, Holmes S. Relieving the pain of sentinel lymph node biopsy tracer injection. Clin J Oncol Nurs. 2008 Aug;12(4):668-70. doi: 10.1188/08.CJON.668-670.</citation>
    <PMID>18676334</PMID>
  </reference>
  <reference>
    <citation>Stojadinovic A, Peoples GE, Jurgens JS, Howard RS, Schuyler B, Kwon KH, Henry LR, Shriver CD, Buckenmaier CC. Standard versus pH-adjusted and lidocaine supplemented radiocolloid for patients undergoing sentinel-lymph-node mapping and biopsy for early breast cancer (PASSION-P trial): a double-blind, randomised controlled trial. Lancet Oncol. 2009 Sep;10(9):849-54. doi: 10.1016/S1470-2045(09)70194-9. Epub 2009 Aug 5.</citation>
    <PMID>19664956</PMID>
  </reference>
  <results_reference>
    <citation>Johnston MJ, Ntambi JA, Hilliard N, Spencer HJ, Vaughn R, Owens SS, Myrick RS, Parker LD, Garner DA, Yarbrough TL. Reducing perceived pain levels during nonbreast lymphoscintigraphy. Clin Nucl Med. 2015 Dec;40(12):945-9. doi: 10.1097/RLU.0000000000000905.</citation>
    <PMID>26222533</PMID>
  </results_reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <results_first_submitted>November 14, 2017</results_first_submitted>
  <results_first_submitted_qc>November 16, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 20, 2017</results_first_posted>
  <last_update_submitted>November 16, 2017</last_update_submitted>
  <last_update_submitted_qc>November 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Alkalinization</keyword>
  <keyword>Technetium 99m Sulfur Colloid</keyword>
  <keyword>sentinel lymphoscintigraphy?</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 17, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT01660412/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Each Participant received four injections. We tested four different injection sites. Each participant received all four injections at one site.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>pH Altered First</title>
          <description>The first injection administered will be the pH altered solution. The second injection will be the standard of care solution (opposite order). The remaining injections will be randomly assigned as either standard of care or pH altered.&#xD;
ph Altered first: For the first injection, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40. For the second injection, the standard of care will be given, and randomly after that either standard of care, or pH altered will be given.</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care First</title>
          <description>The first injection administered will be the standard of care solution (SOC). The second injection will be the pH altered solution. The remaining injections will be randomly assigned as either standard of care or pH altered.&#xD;
Standard of Care First: For the second injection, and randomly after that, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Head</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Thorax</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Appendicular Structures</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Injection 1</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Injection 2</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Injection 3</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Injection 4</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Subjects were randomized into 1 of 2 sequence groups (A and B):&#xD;
Sequence group A. The first injection administered was the standard-of-care (SOC) solution followed by the pH-altered solution. The remaining injections were randomly assigned as either SOC solution or pH-altered.&#xD;
Sequence group B. The first injection administered was the pHaltered solution followed by the SOC solution. The remaining injections were randomly assigned as either SOC solution or pH-altered.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="57"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>lbs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="159.9" spread="46.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Perceived Pain Level</title>
        <description>Immediately after receiving an injection, subjects will rate their perceived pain level, using a validated measure. Subject was asked to quantify the pain of every injection using a validated scale from 0 through 10, with 0 being no pain and 10 being severe pain that is disabling. The effect of treatment was estimated by taking the difference of the mean buffered and SOC pain scores and a paired t-test was used to test whether the mean difference was significantly different from 0. Perceived pain levels assessed after each injection were averaged for each participant.</description>
        <time_frame>immediately after administration (&lt;1 min) of each injection (up to total 5 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care Injection</title>
            <description>Approximately 1mc 99mTc-SC</description>
          </group>
          <group group_id="O2">
            <title>PH Altered Injection</title>
            <description>a diluted bicarbonate solution in a drop wise manner to raise the pH of the 99mTc-SC to a pH of 7.40 ± 0.05, dose Approximately 1mc</description>
          </group>
        </group_list>
        <measure>
          <title>Perceived Pain Level</title>
          <description>Immediately after receiving an injection, subjects will rate their perceived pain level, using a validated measure. Subject was asked to quantify the pain of every injection using a validated scale from 0 through 10, with 0 being no pain and 10 being severe pain that is disabling. The effect of treatment was estimated by taking the difference of the mean buffered and SOC pain scores and a paired t-test was used to test whether the mean difference was significantly different from 0. Perceived pain levels assessed after each injection were averaged for each participant.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.81" spread="2.24"/>
                    <measurement group_id="O2" value="4.39" spread="2.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.42</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>2.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored for each injection up to 5 minutes.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Standard of Care Injection</title>
          <description>Approximately 1mc 99mTc-SC</description>
        </group>
        <group group_id="E2">
          <title>PH Altered Injection</title>
          <description>a diluted bicarbonate solution in a drop wise manner to raise the pH of the 99mTc-SC to a pH of 7.40 ± 0.05, dose Approximately 1mc</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <description>Injection site pain of 8 of 10 or less was not considered an adverse event. Injection site pain of 9/10 or 10/10 was considered an adverse event.</description>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>a sample size of 60 may be inadequate to generalize to all practices.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>James A Ntambi</name_or_title>
      <organization>UAMS</organization>
      <phone>5015265062</phone>
      <email>jantambi@uams.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01660412
org study id: 31337
nct id: NCT01660412
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Pain during nuclear medicine breast lymphnode detection procedures has been reported as high
      as 8.8/10. Using Sodium Bicarbonate to alkalinize the radio-pharmaceutical injection, pain
      can safely be reduced from 6.6/10 to 4.7/10, during breast lymph node detection procedures.

      In sites other then the breast, using Bicarbonate to make the injection's pH closer to
      natural, attempts to lower the pain levels will be performed.

      Hypothesis: The perceived pain level during non breast sentinel lymph node techniques can be
      reduced by raising the pH of the injectate (Tc-99m SC) to near the physiologic level of pH
      7.40.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Perceived Pain Level
time frame: immediately after administration (<1 min) of each injection (up to total 5 minutes)
description: Immediately after receiving an injection, subjects will rate their perceived pain level, using a validated measure. Subject was asked to quantify the pain of every injection using a validated scale from 0 through 10, with 0 being no pain and 10 being severe pain that is disabling. The effect of treatment was estimated by taking the difference of the mean buffered and SOC pain scores and a paired t-test was used to test whether the mean difference was significantly different from 0. Perceived pain levels assessed after each injection were averaged for each participant.
arm group label: pH altered first
arm group type: Active Comparator
description: The first injection administered will be the pH altered solution. The second injection will be the standard of care solution (opposite order). The remaining injections will be randomly assigned as either standard of care or pH altered.
arm group label: Standard of Care first
arm group type: Active Comparator
description: The first injection administered will be the standard of care solution (SOC). The second injection will be the pH altered solution. The remaining injections will be randomly assigned as either standard of care or pH altered.
intervention type: Drug
intervention name: Standard of Care First
description: For the second injection, and randomly after that, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40.
arm group label: Standard of Care first
other name: Sodium Bicarbonate second
intervention type: Drug
intervention name: ph Altered first
description: For the first injection, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40. For the second injection, the standard of care will be given, and randomly after that either standard of care, or pH altered will be given.
arm group label: pH altered first
other name: Sodium Bicarbonate first
criteria: 
gender: All
minimum age: 18 Years
maximum age: 122 Years
healthy volunteers: No
last name: James A Ntambi, MD
role: Principal Investigator
affiliation: UAMS
facility: 
country: United States
citation: Fetzer S, Holmes S. Relieving the pain of sentinel lymph node biopsy tracer injection. Clin J Oncol Nurs. 2008 Aug;12(4):668-70. doi: 10.1188/08.CJON.668-670.
PMID: 18676334
citation: Stojadinovic A, Peoples GE, Jurgens JS, Howard RS, Schuyler B, Kwon KH, Henry LR, Shriver CD, Buckenmaier CC. Standard versus pH-adjusted and lidocaine supplemented radiocolloid for patients undergoing sentinel-lymph-node mapping and biopsy for early breast cancer (PASSION-P trial): a double-blind, randomised controlled trial. Lancet Oncol. 2009 Sep;10(9):849-54. doi: 10.1016/S1470-2045(09)70194-9. Epub 2009 Aug 5.
PMID: 19664956
citation: Johnston MJ, Ntambi JA, Hilliard N, Spencer HJ, Vaughn R, Owens SS, Myrick RS, Parker LD, Garner DA, Yarbrough TL. Reducing perceived pain levels during nonbreast lymphoscintigraphy. Clin Nucl Med. 2015 Dec;40(12):945-9. doi: 10.1097/RLU.0000000000000905.
PMID: 26222533
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: a sample size of 60 may be inadequate to generalize to all practices.
point of contact: 