<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/NCT03824327</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-18215</org_study_id>
    <secondary_id>NCI-2019-00105</secondary_id>
    <nct_id>NCT03824327</nct_id>
  </id_info>
  <brief_title>Papaverine and Stereotactic Body Radiotherapy (SBRT) for Non Small Cell Lung Cancer (NSCLC) or Lung Metastases</brief_title>
  <official_title>A Phase I Trial Combining Papaverine and Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer or Lung Metastases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I trial studies the side effects and how well papaverine hydrochloride and&#xD;
      stereotactic radiation therapy body (SBRT) work in treating patients with non-small cell lung&#xD;
      cancer. Papaverine hydrochloride may help radiation therapy work better by making tumor cells&#xD;
      more sensitive to the radiation therapy. Stereotactic body radiation therapy uses special&#xD;
      equipment to position a patient and deliver radiation to tumors with high precision. This&#xD;
      method can kill tumor cells with fewer doses over a shorter period and cause less damage to&#xD;
      normal tissue. Giving papaverine hydrochloride with SBRT may work in treating patients with&#xD;
      non-small cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the safety and tolerability of concurrent papaverine hydrochloride (PPV), and&#xD;
      lung SBRT in patients with non-small cell lung cancer (NSCLC) or lung metastases.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess primary tumor control rate, local control rate, local-regional recurrence&#xD;
      free-survival (LRRFS), disease-free survival (DFS), distant-metastasis-free survival (DMFS),&#xD;
      and overall survival (OS).&#xD;
&#xD;
      II. To assess whether blood oxygen level-dependent (BOLD) functional magnetic resonance&#xD;
      imaging (MRI) studies can predict which patients may respond best to PPV + SBRT, and detect&#xD;
      changes in oxygenation before and after PPV administration.&#xD;
&#xD;
      III. To assess whether blood-based micro ribonucleic acid (miRNA) biomarkers can predict&#xD;
      which patients may respond best to PPV + SBRT.&#xD;
&#xD;
      OUTLINE: This is a dose-escalation study of papaverine hydrochloride.&#xD;
&#xD;
      Patients undergo BOLD functional magnetic resonance imaging (fMRI) and receive papaverine&#xD;
      hydrochloride intravenously (IV) on day 1. Within 30-90 minutes, patients undergo a second&#xD;
      BOLD fMRI. Patients then receive papaverine hydrochloride IV and within 30-90 minutes after&#xD;
      dose undergo SBRT for a up to 4-5 sessions over 2 weeks.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 4-6 weeks, 3 and 6 months, 1&#xD;
      and 2 years, then every 3 months for 2 years, and then every 6 months for 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum-tolerated dose (MTD)</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>Will employ the Bayesian optimal interval (BOIN) design to find the MTD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary tumor control</measure>
    <time_frame>At 12 and 24 months after stereotactic body radiation therapy (SBRT) completion</time_frame>
    <description>Primary tumor control is defined as the absence of primary tumor failure. Will be calculated and 95% exact binomial confidence interval will be provided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local control rate (primary tumor control + involved lobar control)</measure>
    <time_frame>Up to 12 months after SBRT completion</time_frame>
    <description>Local control is defined as the absence of local failure. Will be calculated and 95% exact binomial confidence interval will be provided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local-regional recurrence free-survival</measure>
    <time_frame>From time of entry onto study until the time of documented local-regional recurrence or death, assessed up to 12 months after SBRT completion</time_frame>
    <description>Will be summarized using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis-free survival</measure>
    <time_frame>Time from entry onto study until the time of documented metastatic recurrence or death, assessed up to 12 months after SBRT treatment</time_frame>
    <description>Will be summarized using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>Time from entry onto study until the time of any documented disease recurrence or death, assessed up to 12 months after SBRT completion</time_frame>
    <description>Will be summarized using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Time from study entry until time of death from any cause, assessed up to 12 months after SBRT completion</time_frame>
    <description>Will be summarized using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in magnetic resonance imaging (MRI) blood oxygen level-dependent (BOLD) response</measure>
    <time_frame>Up to 4 hours</time_frame>
    <description>Will be measured before and after papaverine hydrochloride (PPV) delivery by the percentage change in relaxation rate on MRI. Will also analyze biomarkers descriptively and graphically to assess trends in changes in these markers over time and the association with response. Exploratory comparisons of groups of patients based on response will involve the use of analysis of variance (ANOVA) for continuous data and categorical methods such as Fisher?s exact and chi-square tests for discrete data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hypoxia-inducible micro ribonucleic acids (miRNAs)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Will analyze patient serum pre-and post-treatment for hypoxia-associated at pre- and post- SBRT treatment hypoxia-inducible microRNAs (miRs) using nanoString miRNA assay that could indicate the presence of tumor hypoxia. The changes in circulating biomarkers will be validated by alternative quantitative polymerase chain reaction (qPCR) based approaches. These results will be cross-validated with the BOLD data. Will also analyze biomarkers descriptively and graphically to assess trends in changes in these markers over time and the association with response. Exploratory comparisons of groups of patients based on response will involve the use of ANOVA for continuous data and categorical methods such as Fisher?s exact and chi-square tests for discrete data.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Lung Non-Small Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo BOLD fMRI and receive papaverine hydrochloride IV on day 1. Within 30-90 minutes, patients undergo a second BOLD fMRI. Patients then receive papaverine hydrochloride IV and within 30-90 minutes after dose undergo SBRT for a up to 4-5 sessions over 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood Oxygen Level Dependent Imaging</intervention_name>
    <description>Undergo BOLD fMRI</description>
    <arm_group_label>Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)</arm_group_label>
    <other_name>Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging</other_name>
    <other_name>BOLD</other_name>
    <other_name>BOLD fMRI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Papaverine Hydrochloride</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)</arm_group_label>
    <other_name>Cerebid</other_name>
    <other_name>Cerespan</other_name>
    <other_name>Pap H</other_name>
    <other_name>Pavabid</other_name>
    <other_name>Pavacap</other_name>
    <other_name>Therapav</other_name>
    <other_name>Vasal</other_name>
    <other_name>Vaso-Pav</other_name>
    <other_name>Vasospan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiation Therapy</intervention_name>
    <description>Undergo SBRT</description>
    <arm_group_label>Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)</arm_group_label>
    <other_name>SABR</other_name>
    <other_name>SBRT</other_name>
    <other_name>Stereotactic Ablative Body Radiation Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically proven NSCLC for whom SBRT to a single lesion has been&#xD;
             chosen as the primary treatment modality (planned dose 50 Gy in 4-5 daily fractions).&#xD;
             Patients with lung metastases from solid tumors are eligible.&#xD;
&#xD;
          -  Patients must have a tumor =&lt; 5 cm as defined by computed tomography (CT) largest&#xD;
             axial dimension. Presence of adjacent nodules considered neoplastic in the same lobe&#xD;
             or other ipsilateral lobe are allowed as long as the nodule(s) can be encompassed in&#xD;
             an SBRT gross tumor volume (GTV) of =&lt; 5 cm, within 1 isocenter. Multiple isocenters&#xD;
             are not allowed&#xD;
&#xD;
          -  No prior radiation resulting in overlapping fields&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
          -  Must be able to undergo correlative research MRIs&#xD;
&#xD;
          -  No active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis&#xD;
             (IPF)&#xD;
&#xD;
          -  No history of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis),&#xD;
             or priapism&#xD;
&#xD;
          -  Within 30 days of registration: patients must have vital signs, history/physical&#xD;
             examination, and laboratory studies (liver function tests, creatinine or creatinine&#xD;
             clearance assessment)&#xD;
&#xD;
          -  Life expectancy of at least 12 weeks in the opinion of investigator&#xD;
&#xD;
          -  Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14&#xD;
             days of registration. Urine human chorionic gonadotropin (HCG) is an acceptable&#xD;
             pregnancy assessment. Nursing women may participate only if nursing is discontinued,&#xD;
             due to the possibility of harm to nursing infants from the treatment regimen&#xD;
&#xD;
          -  Within 90 days of registration: pulmonary function tests (PFTs) including forced&#xD;
             expiratory volume in 1 second (FEV-1) and diffusion capacity of the lung for carbon&#xD;
             monoxide (DLCO)&#xD;
&#xD;
          -  Albumin &gt;= 2.5 g/dL (within 30 days of study registration)&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 x upper limit of normal (ULN) (within 30 days of study&#xD;
             registration)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =&lt; 2.5 x ULN&#xD;
             (within 30 days of study registration)&#xD;
&#xD;
          -  Creatinine =&lt; 1.5 x ULN or calculated creatinine &gt;= 50 mL/min, calculated by the&#xD;
             Cockcroft-Gault formula or 24-hour urine creatinine clearance &gt;= 50 mL/min (within 30&#xD;
             days of study registration)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of another malignancy&#xD;
&#xD;
               -  Exception: Subjects who have been disease-free for &gt;= 3 years, or subjects with a&#xD;
                  history of localized prostate cancer, in situ carcinoma (e.g. breast, cervix,&#xD;
                  oral cavity), differentiated thyroid neoplasm, completely resected non-melanoma&#xD;
                  skin cancer, are eligible&#xD;
&#xD;
          -  Any serious and/or unstable pre-existing medical disorder (aside from malignancy&#xD;
             exception above), psychiatric disorder, or other conditions that could interfere with&#xD;
             subject?s safety, obtaining informed consent or compliance to the study procedures, in&#xD;
             the opinion of the investigator&#xD;
&#xD;
          -  Pregnancy or breastfeeding: Women of child-bearing potential and men must agree to use&#xD;
             adequate contraception (hormonal or barrier method of birth control; abstinence) prior&#xD;
             to study entry, the duration of study participation and for 4 months after the last&#xD;
             dose of study treatment. Should a woman become pregnant or suspect she is pregnant&#xD;
             while participating in this study, she should inform her treating physician&#xD;
             immediately. No breastfeeding while patient is on study&#xD;
&#xD;
          -  Patients with history of pneumonectomy&#xD;
&#xD;
          -  Prior cytotoxic chemotherapy, molecularly-targeted agents (e.g. erlotinib,&#xD;
             crizotinib), or immunotherapy unless &gt;= 2 weeks from last dose. Patients can start&#xD;
             chemotherapy, immunotherapy, or other systemic therapy after completion of SBRT, but&#xD;
             this should be planned for ≥ 2 weeks from last SBRT dose.&#xD;
&#xD;
          -  History of active connective tissue disease (scleroderma), idiopathic pulmonary&#xD;
             fibrosis, pneumonitis&#xD;
&#xD;
          -  Hepatic insufficiency resulting in jaundice and/or coagulation defects, or not meeting&#xD;
             laboratory values (albumin, total bilirubin, AST/ALT)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeremy Brownstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>The Ohio State University Comprehensive Cancer Center</last_name>
    <phone>1-800-293-5066</phone>
    <email>OSUCCCClinicaltrials@osumc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Morgan Hill</last_name>
    <phone>614-366-0150</phone>
    <email>morgan.hill@osumc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeremy Brownstein, MD</last_name>
      <phone>614-293-8415</phone>
      <email>Jeremy.Brownstein@osumc.edu</email>
    </contact>
    <investigator>
      <last_name>Jeremy Brownstein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>June 9, 2022</last_update_submitted>
  <last_update_submitted_qc>June 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Jeremy Brownstein</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papaverine</mesh_term>
  </intervention_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/NCT03824327
org study id: OSU-18215
secondary id: NCI-2019-00105
nct id: NCT03824327
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase I trial studies the side effects and how well papaverine hydrochloride and
      stereotactic radiation therapy body (SBRT) work in treating patients with non-small cell lung
      cancer. Papaverine hydrochloride may help radiation therapy work better by making tumor cells
      more sensitive to the radiation therapy. Stereotactic body radiation therapy uses special
      equipment to position a patient and deliver radiation to tumors with high precision. This
      method can kill tumor cells with fewer doses over a shorter period and cause less damage to
      normal tissue. Giving papaverine hydrochloride with SBRT may work in treating patients with
      non-small cell lung cancer.
PRIMARY OBJECTIVES:

      I. To assess the safety and tolerability of concurrent papaverine hydrochloride (PPV), and
      lung SBRT in patients with non-small cell lung cancer (NSCLC) or lung metastases.

      SECONDARY OBJECTIVES:

      I. To assess primary tumor control rate, local control rate, local-regional recurrence
      free-survival (LRRFS), disease-free survival (DFS), distant-metastasis-free survival (DMFS),
      and overall survival (OS).

      II. To assess whether blood oxygen level-dependent (BOLD) functional magnetic resonance
      imaging (MRI) studies can predict which patients may respond best to PPV + SBRT, and detect
      changes in oxygenation before and after PPV administration.

      III. To assess whether blood-based micro ribonucleic acid (miRNA) biomarkers can predict
      which patients may respond best to PPV + SBRT.

      OUTLINE: This is a dose-escalation study of papaverine hydrochloride.

      Patients undergo BOLD functional magnetic resonance imaging (fMRI) and receive papaverine
      hydrochloride intravenously (IV) on day 1. Within 30-90 minutes, patients undergo a second
      BOLD fMRI. Patients then receive papaverine hydrochloride IV and within 30-90 minutes after
      dose undergo SBRT for a up to 4-5 sessions over 2 weeks.

      After completion of study treatment, patients are followed up at 4-6 weeks, 3 and 6 months, 1
      and 2 years, then every 3 months for 2 years, and then every 6 months for 3 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum-tolerated dose (MTD)
time frame: Up to 2 weeks
description: Will employ the Bayesian optimal interval (BOIN) design to find the MTD.
measure: Primary tumor control
time frame: At 12 and 24 months after stereotactic body radiation therapy (SBRT) completion
description: Primary tumor control is defined as the absence of primary tumor failure. Will be calculated and 95% exact binomial confidence interval will be provided.
measure: Local control rate (primary tumor control + involved lobar control)
time frame: Up to 12 months after SBRT completion
description: Local control is defined as the absence of local failure. Will be calculated and 95% exact binomial confidence interval will be provided.
measure: Local-regional recurrence free-survival
time frame: From time of entry onto study until the time of documented local-regional recurrence or death, assessed up to 12 months after SBRT completion
description: Will be summarized using Kaplan-Meier method.
measure: Distant metastasis-free survival
time frame: Time from entry onto study until the time of documented metastatic recurrence or death, assessed up to 12 months after SBRT treatment
description: Will be summarized using Kaplan-Meier method.
measure: Disease-free survival
time frame: Time from entry onto study until the time of any documented disease recurrence or death, assessed up to 12 months after SBRT completion
description: Will be summarized using Kaplan-Meier method.
measure: Overall survival
time frame: Time from study entry until time of death from any cause, assessed up to 12 months after SBRT completion
description: Will be summarized using Kaplan-Meier method.
measure: Changes in magnetic resonance imaging (MRI) blood oxygen level-dependent (BOLD) response
time frame: Up to 4 hours
description: Will be measured before and after papaverine hydrochloride (PPV) delivery by the percentage change in relaxation rate on MRI. Will also analyze biomarkers descriptively and graphically to assess trends in changes in these markers over time and the association with response. Exploratory comparisons of groups of patients based on response will involve the use of analysis of variance (ANOVA) for continuous data and categorical methods such as Fisher?s exact and chi-square tests for discrete data.
measure: Change in hypoxia-inducible micro ribonucleic acids (miRNAs)
time frame: Up to 3 months
description: Will analyze patient serum pre-and post-treatment for hypoxia-associated at pre- and post- SBRT treatment hypoxia-inducible microRNAs (miRs) using nanoString miRNA assay that could indicate the presence of tumor hypoxia. The changes in circulating biomarkers will be validated by alternative quantitative polymerase chain reaction (qPCR) based approaches. These results will be cross-validated with the BOLD data. Will also analyze biomarkers descriptively and graphically to assess trends in changes in these markers over time and the association with response. Exploratory comparisons of groups of patients based on response will involve the use of ANOVA for continuous data and categorical methods such as Fisher?s exact and chi-square tests for discrete data.
arm group label: Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)
arm group type: Experimental
description: Patients undergo BOLD fMRI and receive papaverine hydrochloride IV on day 1. Within 30-90 minutes, patients undergo a second BOLD fMRI. Patients then receive papaverine hydrochloride IV and within 30-90 minutes after dose undergo SBRT for a up to 4-5 sessions over 2 weeks.
intervention type: Procedure
intervention name: Blood Oxygen Level Dependent Imaging
description: Undergo BOLD fMRI
arm group label: Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)
other name: Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging
other name: BOLD
other name: BOLD fMRI
intervention type: Drug
intervention name: Papaverine Hydrochloride
description: Given IV
arm group label: Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)
other name: Cerebid
other name: Cerespan
other name: Pap H
other name: Pavabid
other name: Pavacap
other name: Therapav
other name: Vasal
other name: Vaso-Pav
other name: Vasospan
intervention type: Radiation
intervention name: Stereotactic Body Radiation Therapy
description: Undergo SBRT
arm group label: Treatment (BOLD fMRI, papaverine hydrochloride, SBRT)
other name: SABR
other name: SBRT
other name: Stereotactic Ablative Body Radiation Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeremy Brownstein, MD
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
last name: The Ohio State University Comprehensive Cancer Center
phone: 1-800-293-5066
email: OSUCCCClinicaltrials@osumc.edu
last name: Morgan Hill
phone: 614-366-0150
email: morgan.hill@osumc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Principal Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: Jeremy Brownstein
investigator title: Principal Investigator
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Papaverine
sharing ipd: No