<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/NCT04495985</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 20-488</org_study_id>
    <nct_id>NCT04495985</nct_id>
  </id_info>
  <brief_title>CASE 1320: RAI Uptake and Serum Prolactin in Thyroid Cancer</brief_title>
  <official_title>Breast Uptake on Radioiodine Scan and Serum Prolactin in Thyroid Cancer Patients Prepared by Thyroid Hormone Withdrawal or Recombinant Human Thyrotropin: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radioactive iodine (RAI) is a radioisotope used to ablate thyroid gland remnant after&#xD;
      thyroidectomy in patients diagnosed with differentiated thyroid carcinoma (DTC). A whole body&#xD;
      scan (WBS) is performed to not only evaluate for iodine uptake by the native thyroid tissue&#xD;
      but also to observe for uptake in other areas of the body, which could be physiological or&#xD;
      indicative of iodide-avid metastases. Research has shown a correlation between breast cancer&#xD;
      and thyroid cancer. Patients with DTC have been found to have elevated levels of serum&#xD;
      prolactin, which could lead to mammary gland dysfunction.&#xD;
&#xD;
      In patients with DTC undergoing RAI scanning or therapy, it has been previously observed that&#xD;
      patients prepared by thyroid hormone withdrawal have significantly higher breast uptake on&#xD;
      whole body scan compared to those prepared by rh-TSH. Considering the impact of prolactin on&#xD;
      breast tissue, this study aims to correlate these findings with the lab values and the method&#xD;
      of preparation.&#xD;
&#xD;
      Accordingly, the research question is as follows: does the method of WBS preparation impact&#xD;
      prolactin levels and how does that correlate with breast uptake in patients with DTC&#xD;
      undergoing RAI WBS?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radioactive iodine (RAI) is a radioisotope used to ablate thyroid gland remnant after&#xD;
      thyroidectomy in patients diagnosed with differentiated thyroid carcinoma (DTC). A whole body&#xD;
      scan (WBS) is performed to not only evaluate for iodine uptake by the native thyroid tissue&#xD;
      but also to observe for uptake in other areas of the body, which could be physiological or&#xD;
      indicative of iodide-avid metastases. Research has shown a correlation between breast cancer&#xD;
      and thyroid cancer. Patients with DTC have been found to have elevated levels of serum&#xD;
      prolactin, which could lead to mammary gland dysfunction. As such, this study will evaluate&#xD;
      for breast uptake on the RAI WBS. Research has shown that patients with DTC may have uptake&#xD;
      on RAI WBS.&#xD;
&#xD;
      There is a concern in the molecular imaging community and oncology community that increased&#xD;
      I-131 retention in breast tissue may increase the risk of future breast malignancy. The&#xD;
      notion that increased serum prolactin concentration increases iodine uptake in breast tissue&#xD;
      comes mostly from case series. A correlation between high prolactin as a result of withdrawal&#xD;
      from thyroid hormone treatment vs stimulation by recombinant human thyrotropin and uptake by&#xD;
      thyroid tissue is the main research question. This research will not be able to answer the&#xD;
      question of whether such breast uptake is associated with the future risk breast malignancy.&#xD;
      The later research question should be undertaken by other researchers in a larger study with&#xD;
      longer follow up. Metastases to the breast from thyroid cancer are rare. Uptake in a discrete&#xD;
      lesion in the breast will need to be investigated. It is unclear whether breast&#xD;
      adenocarcinoma will concentrate iodine.&#xD;
&#xD;
      In a previous retrospective study of 194 patients with DTC and no breast cancer, it was&#xD;
      demonstrated that patients prepared by withdrawal from thyroid hormone had 5-fold higher peak&#xD;
      I-131 uptake in breast tissue on post-therapy scan compared to patients prepared by&#xD;
      recombinant human thyrotropin (rh-TSH). In other research, DTC patients with&#xD;
      hyperprolactinemia have been found to have increased uptake by the mammary gland. The&#xD;
      hypothesis is that patients prepared by withdrawal would have increased serum prolactin&#xD;
      compared to patients prepared by rh-TSH who are not made hypothyroid. This study plans to&#xD;
      prospectively evaluate serum prolactin and breast uptake on the RAI WBS and assess the impact&#xD;
      of pre-scan preparation on those variables. This would be the first prospective study of its&#xD;
      kind in this set of patients to look at whether the method of pre-RAI scan preparation might&#xD;
      impact RAI uptake with correlation to prolactin levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Actual">July 27, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Breast uptake of I-131 on whole body radioactive iodine scan</measure>
    <time_frame>10 days after treatment</time_frame>
    <description>Breast uptake of I-131 on whole body radioactive iodine scan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in serum prolactin concentration</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change in prolactin levels in thyroid hormone withdrawal group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum prolactin concentration</measure>
    <time_frame>3 days</time_frame>
    <description>Change in prolactin levels in thyrogen preparation group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolactin level and breast uptake of I-131</measure>
    <time_frame>Day 46 of thyroid hormone withdrawal group</time_frame>
    <description>Correlation between serum prolactin level and breast uptake of I-131</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolactin level and breast uptake of I-131</measure>
    <time_frame>Day 26 of thyrogen preparation group</time_frame>
    <description>Correlation between serum prolactin level and breast uptake of I-131</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">39</enrollment>
  <condition>Thyroid Cancer</condition>
  <arm_group>
    <arm_group_label>Thyrogen (rh-TSH)</arm_group_label>
    <description>Group 1: Female patients prepared for radioactive iodine treatment by rh-TSH (Thyrogen)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Withdrawal from thyroid hormone</arm_group_label>
    <description>Group 2: Female patients prepared for radioactive iodine treatment by withdrawal from thyroid hormones</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Group 1: Female patients with differential thyroid cancer prepared for radioactive iodine&#xD;
        whole body scan by withdrawal from thyroid hormones Group 2: Female patients with&#xD;
        differential thyroid cancer prepared for radioactive iodine whole body scan by rh-TSH.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients with diagnosis of differentiated thyroid carcinoma who have had&#xD;
             thyroidectomy performed previously&#xD;
&#xD;
          -  Patients able to understand and sign informed consent for imaging&#xD;
&#xD;
          -  Patients already scheduled to undergo radioactive iodine whole body scanning (RAI WBS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Patients with a history of breast cancer&#xD;
&#xD;
          -  Patients with a known history of hyperprolactinemia&#xD;
&#xD;
          -  Patients receiving medications known to raise serum prolactin&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandra Mikhael, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 5, 2023</last_update_submitted>
  <last_update_submitted_qc>July 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04495985
org study id: IRB 20-488
nct id: NCT04495985
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Radioactive iodine (RAI) is a radioisotope used to ablate thyroid gland remnant after
      thyroidectomy in patients diagnosed with differentiated thyroid carcinoma (DTC). A whole body
      scan (WBS) is performed to not only evaluate for iodine uptake by the native thyroid tissue
      but also to observe for uptake in other areas of the body, which could be physiological or
      indicative of iodide-avid metastases. Research has shown a correlation between breast cancer
      and thyroid cancer. Patients with DTC have been found to have elevated levels of serum
      prolactin, which could lead to mammary gland dysfunction.

      In patients with DTC undergoing RAI scanning or therapy, it has been previously observed that
      patients prepared by thyroid hormone withdrawal have significantly higher breast uptake on
      whole body scan compared to those prepared by rh-TSH. Considering the impact of prolactin on
      breast tissue, this study aims to correlate these findings with the lab values and the method
      of preparation.

      Accordingly, the research question is as follows: does the method of WBS preparation impact
      prolactin levels and how does that correlate with breast uptake in patients with DTC
      undergoing RAI WBS?
Radioactive iodine (RAI) is a radioisotope used to ablate thyroid gland remnant after
      thyroidectomy in patients diagnosed with differentiated thyroid carcinoma (DTC). A whole body
      scan (WBS) is performed to not only evaluate for iodine uptake by the native thyroid tissue
      but also to observe for uptake in other areas of the body, which could be physiological or
      indicative of iodide-avid metastases. Research has shown a correlation between breast cancer
      and thyroid cancer. Patients with DTC have been found to have elevated levels of serum
      prolactin, which could lead to mammary gland dysfunction. As such, this study will evaluate
      for breast uptake on the RAI WBS. Research has shown that patients with DTC may have uptake
      on RAI WBS.

      There is a concern in the molecular imaging community and oncology community that increased
      I-131 retention in breast tissue may increase the risk of future breast malignancy. The
      notion that increased serum prolactin concentration increases iodine uptake in breast tissue
      comes mostly from case series. A correlation between high prolactin as a result of withdrawal
      from thyroid hormone treatment vs stimulation by recombinant human thyrotropin and uptake by
      thyroid tissue is the main research question. This research will not be able to answer the
      question of whether such breast uptake is associated with the future risk breast malignancy.
      The later research question should be undertaken by other researchers in a larger study with
      longer follow up. Metastases to the breast from thyroid cancer are rare. Uptake in a discrete
      lesion in the breast will need to be investigated. It is unclear whether breast
      adenocarcinoma will concentrate iodine.

      In a previous retrospective study of 194 patients with DTC and no breast cancer, it was
      demonstrated that patients prepared by withdrawal from thyroid hormone had 5-fold higher peak
      I-131 uptake in breast tissue on post-therapy scan compared to patients prepared by
      recombinant human thyrotropin (rh-TSH). In other research, DTC patients with
      hyperprolactinemia have been found to have increased uptake by the mammary gland. The
      hypothesis is that patients prepared by withdrawal would have increased serum prolactin
      compared to patients prepared by rh-TSH who are not made hypothyroid. This study plans to
      prospectively evaluate serum prolactin and breast uptake on the RAI WBS and assess the impact
      of pre-scan preparation on those variables. This would be the first prospective study of its
      kind in this set of patients to look at whether the method of pre-RAI scan preparation might
      impact RAI uptake with correlation to prolactin levels.
observational model: Cohort
time perspective: Prospective
measure: Breast uptake of I-131 on whole body radioactive iodine scan
time frame: 10 days after treatment
description: Breast uptake of I-131 on whole body radioactive iodine scan
measure: Change in serum prolactin concentration
time frame: 6 weeks
description: Change in prolactin levels in thyroid hormone withdrawal group
measure: Serum prolactin concentration
time frame: 3 days
description: Change in prolactin levels in thyrogen preparation group
measure: Prolactin level and breast uptake of I-131
time frame: Day 46 of thyroid hormone withdrawal group
description: Correlation between serum prolactin level and breast uptake of I-131
measure: Prolactin level and breast uptake of I-131
time frame: Day 26 of thyrogen preparation group
description: Correlation between serum prolactin level and breast uptake of I-131
arm group label: Thyrogen (rh-TSH)
description: Group 1: Female patients prepared for radioactive iodine treatment by rh-TSH (Thyrogen)
arm group label: Withdrawal from thyroid hormone
description: Group 2: Female patients prepared for radioactive iodine treatment by withdrawal from thyroid hormones
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandra Mikhael, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases
sharing ipd: No