<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/NCT03778294</url>
  </required_header>
  <id_info>
    <org_study_id>MC1774</org_study_id>
    <secondary_id>NCI-2018-02800</secondary_id>
    <secondary_id>MC1774</secondary_id>
    <nct_id>NCT03778294</nct_id>
  </id_info>
  <brief_title>18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy</brief_title>
  <official_title>Phase II Study of Short Course Hypofractionated Proton Beam Therapy Incorporating 18F-DOPA-PET/MRI for Elderly Patients With Newly Diagnosed Glioblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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 II trial studies how well fluorodopa F 18-positron emission tomography/magnetic&#xD;
      resonance imaging scan (18F-DOPA-PET/MRI) works in imaging elderly patients with newly&#xD;
      diagnosed grade IV malignant glioma or glioblastoma during planning for a short course of&#xD;
      proton beam radiation therapy. 18F-DOPA is a chemical tracer that highlights certain cells&#xD;
      during imaging. PET scan, is a metabolic imaging technique which takes advantage of how tumor&#xD;
      cells take up nutrients differently than normal tissue. MRI scans are used to guide radiation&#xD;
      therapy for most brain tumors. Hypofractionated proton beam therapy delivers higher doses of&#xD;
      radiation therapy over a shorter period of time and may kill more tumor cells and have fewer&#xD;
      side effects. Using 18FDOPA-PET scans along with MRI scans may be able to provide the&#xD;
      radiation doctor with information on tumor tissue versus normal, healthy tissue and may help&#xD;
      the doctor more accurately plan the radiation treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. Compare overall survival at 12 months for grade IV glioma patients after radiation therapy&#xD;
      targeting volumes designed with both 18F-DOPA-PET and conventional magnetic resonance (MR)&#xD;
      image (or PET/computed tomography [CT]) information with historical controls.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Compare progression free survival at 12 months after radiation therapy targeting volumes&#xD;
      designed with both 18F-DOPA-PET and conventional MR image information with historical&#xD;
      controls.&#xD;
&#xD;
      II. Determine acute and late effect toxicity after hypofractionated proton beam radiotherapy&#xD;
      treatment including areas of high 18F-DOPA-PET uptake (T/N &gt; 2.0).&#xD;
&#xD;
      CORRELATIVE RESEARCH OBJECTIVES:&#xD;
&#xD;
      I. Compare radiotherapy (RT) treatment volumes defined by MR only with RT treatment volumes&#xD;
      defined with both PET and MR information for grade IV glioma patients.&#xD;
&#xD;
      II. Compare differences in RT volumes identified using biopsy-validated thresholds as highly&#xD;
      aggressive disease comparing 18F-DOPA uptake and relative cerebral blood volume (relCBV) from&#xD;
      perfusion MRI (pMRI) as well as differences in RT volumes identified using biopsy-validated&#xD;
      thresholds as tumor extent comparing 18F-DOPA uptake and diffusion maps from diffusion tensor&#xD;
      imaging (DTI) will be evaluated.&#xD;
&#xD;
      III. Evaluate quality of life after radiotherapy using European Organization for Research and&#xD;
      Treatment of Cancer (EORTC) questionnaires compared with historical controls from&#xD;
      Keim-Guibert et al.&#xD;
&#xD;
      IV. Compare differences in proton radiation planning utilizing radiobiologic&#xD;
      modeling/evaluation techniques performed at Mayo Clinic Rochester to linear energy transfer&#xD;
      distribution evaluation at Mayo Clinic Arizona.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive 18F-DOPA intravenously (IV) and undergo PET/MRI or PET/CT imaging scan.&#xD;
      Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding&#xD;
      weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients&#xD;
      receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28&#xD;
      days for up to 7 cycles in the in the absence of disease progression or unacceptable&#xD;
      toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 2 months for 1 year, and&#xD;
      then periodically for up to 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 28, 2019</start_date>
  <completion_date type="Anticipated">November 26, 2023</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <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>Overall survival (OS)</measure>
    <time_frame>Time from registration to death due to any cause, assessed up to 12 months</time_frame>
    <description>The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated utilizing exact binomial methodology. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>At 12 months after radiation therapy</time_frame>
    <description>The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated utilizing exact binomial methodology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>Time from registration to the earliest date documenting disease progression, assessed up to 5 years</time_frame>
    <description>The distribution of progression free survival times groups will be estimated using the method of Kaplan-Meier (1958).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>Up to 5 years post treatment</time_frame>
    <description>The rate of acute and late treatment-related toxicities for newly diagnosed high-grade glioma patients treated with fluorodopa F 18-positron emission tomography (18F-DOPA PET) image-guided hypofractionated proton beam therapy will be determined, with acute radiotherapy (RT) toxicities graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Radiotherapy (RT) treatment volumes</measure>
    <time_frame>Up to 5 years post treatment</time_frame>
    <description>Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between treatment volumes defined by magnetic resonance (MR) only and treatment volumes defined with both positron emission tomography (PET) and MR information.</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life (QOL)</measure>
    <time_frame>Up to 5 years post treatment</time_frame>
    <description>QOL surveys will be compared to data from historical controls. Quality of life will be assessed at baseline and at each magnetic resonance imaging (MRI) evaluation (up to 6 evaluations). QOL will be measured using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30.</description>
  </other_outcome>
  <other_outcome>
    <measure>Differences in proton radiation planning</measure>
    <time_frame>Up to 5 years post treatment</time_frame>
    <description>Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between proton plan metrics based off the two modeling/evaluation techniques.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Glioblastoma</condition>
  <condition>Malignant Glioma</condition>
  <arm_group>
    <arm_group_label>Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computed Tomography</intervention_name>
    <description>Undergo PET/CT</description>
    <arm_group_label>Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)</arm_group_label>
    <other_name>CAT</other_name>
    <other_name>CAT Scan</other_name>
    <other_name>Computerized Axial Tomography</other_name>
    <other_name>Computerized Tomography</other_name>
    <other_name>CT</other_name>
    <other_name>CT Scan</other_name>
    <other_name>tomography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fluorodopa F 18</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)</arm_group_label>
    <other_name>(18F)FDOPA</other_name>
    <other_name>18F-DOPA</other_name>
    <other_name>18F-FDOPA</other_name>
    <other_name>3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanine</other_name>
    <other_name>6-(18F)Fluoro-L-DOPA</other_name>
    <other_name>Fluorine F 18 Fluorodopa</other_name>
    <other_name>Fluorine-18-fluoro-L-DOPA</other_name>
    <other_name>Fluorodopa (18F)</other_name>
    <other_name>FLUORODOPA F-18</other_name>
    <other_name>L-6-(18F)Fluoro-DOPA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Resonance Imaging</intervention_name>
    <description>Undergo PET/MRI</description>
    <arm_group_label>Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)</arm_group_label>
    <other_name>Magnetic Resonance Imaging Scan</other_name>
    <other_name>Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance</other_name>
    <other_name>MR Imaging</other_name>
    <other_name>MRI</other_name>
    <other_name>MRI Scan</other_name>
    <other_name>NMR Imaging</other_name>
    <other_name>NMRI</other_name>
    <other_name>Nuclear Magnetic Resonance Imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>Undergo PET/CT or PET/MRI</description>
    <arm_group_label>Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)</arm_group_label>
    <other_name>Medical Imaging, Positron Emission Tomography</other_name>
    <other_name>PET</other_name>
    <other_name>PET Scan</other_name>
    <other_name>Positron Emission Tomography Scan</other_name>
    <other_name>Positron-Emission Tomography</other_name>
    <other_name>proton magnetic resonance spectroscopic imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Proton Beam Radiation Therapy</intervention_name>
    <description>Receive proton beam RT</description>
    <arm_group_label>Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)</arm_group_label>
    <other_name>PBRT</other_name>
    <other_name>Proton</other_name>
    <other_name>Proton Radiation Therapy</other_name>
    <other_name>Radiation, Proton Beam</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temozolomide</intervention_name>
    <description>Drug</description>
    <arm_group_label>Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)</arm_group_label>
    <other_name>CCRG-81045</other_name>
    <other_name>Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-</other_name>
    <other_name>M &amp; B 39831</other_name>
    <other_name>M and B 39831</other_name>
    <other_name>Methazolastone</other_name>
    <other_name>RP-46161</other_name>
    <other_name>SCH 52365</other_name>
    <other_name>Temcad</other_name>
    <other_name>Temodal</other_name>
    <other_name>Temodar</other_name>
    <other_name>Temomedac</other_name>
    <other_name>TMZ</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed newly diagnosed grade IV malignant glioma&#xD;
&#xD;
          -  Planned radiation treatments at Mayo Clinic Arizona or Mayo Clinic Rochester&#xD;
&#xD;
          -  Willing to sign release of information for any radiation and/or follow-up records&#xD;
&#xD;
          -  Provide informed written consent&#xD;
&#xD;
          -  Patients with estimated glomerular filtration rate (eGFR) &gt;= 60 mg/min/1.72 m^2&#xD;
&#xD;
          -  Ability to complete questionnaire(s) by themselves or with assistance&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with grades I-III glioma&#xD;
&#xD;
          -  Currently on Avastin at time of treatment&#xD;
&#xD;
          -  Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator,&#xD;
             kidney failure)&#xD;
&#xD;
          -  Unable to undergo an 18F-DOPA-PET scan (e.g. Parkinson's disease, taking&#xD;
             anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from&#xD;
             discontinuance of dopamine agonists)&#xD;
&#xD;
               -  NOTE: Other potentially interfering drugs: amoxapine, amphetamine, benztropine,&#xD;
                  buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate,&#xD;
                  norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine,&#xD;
                  citalopram, and sertraline. If a patient is on any of these drugs, list which&#xD;
                  ones on the on-study form&#xD;
&#xD;
          -  Pregnant women, nursing women, or men or women of childbearing potential who are&#xD;
             unwilling to employ adequate contraception.&#xD;
&#xD;
               -  NOTE: All women enrolled in this study will be age 65 or over, and at the&#xD;
                  determination of the principal investigator (PI), will not be of childbearing&#xD;
                  potential. If the radiology department requires a pregnancy test before&#xD;
                  administering the 18FDOPA injection, they may perform one per their standard of&#xD;
                  care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sujay A Vora</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>January 5, 2023</last_update_submitted>
  <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 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>Glioblastoma</mesh_term>
    <mesh_term>Glioma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temozolomide</mesh_term>
    <mesh_term>Levodopa</mesh_term>
    <mesh_term>Fluorides</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03778294
org study id: MC1774
secondary id: NCI-2018-02800
secondary id: MC1774
nct id: NCT03778294
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies how well fluorodopa F 18-positron emission tomography/magnetic
      resonance imaging scan (18F-DOPA-PET/MRI) works in imaging elderly patients with newly
      diagnosed grade IV malignant glioma or glioblastoma during planning for a short course of
      proton beam radiation therapy. 18F-DOPA is a chemical tracer that highlights certain cells
      during imaging. PET scan, is a metabolic imaging technique which takes advantage of how tumor
      cells take up nutrients differently than normal tissue. MRI scans are used to guide radiation
      therapy for most brain tumors. Hypofractionated proton beam therapy delivers higher doses of
      radiation therapy over a shorter period of time and may kill more tumor cells and have fewer
      side effects. Using 18FDOPA-PET scans along with MRI scans may be able to provide the
      radiation doctor with information on tumor tissue versus normal, healthy tissue and may help
      the doctor more accurately plan the radiation treatment.
PRIMARY OBJECTIVE:

      I. Compare overall survival at 12 months for grade IV glioma patients after radiation therapy
      targeting volumes designed with both 18F-DOPA-PET and conventional magnetic resonance (MR)
      image (or PET/computed tomography [CT]) information with historical controls.

      SECONDARY OBJECTIVES:

      I. Compare progression free survival at 12 months after radiation therapy targeting volumes
      designed with both 18F-DOPA-PET and conventional MR image information with historical
      controls.

      II. Determine acute and late effect toxicity after hypofractionated proton beam radiotherapy
      treatment including areas of high 18F-DOPA-PET uptake (T/N > 2.0).

      CORRELATIVE RESEARCH OBJECTIVES:

      I. Compare radiotherapy (RT) treatment volumes defined by MR only with RT treatment volumes
      defined with both PET and MR information for grade IV glioma patients.

      II. Compare differences in RT volumes identified using biopsy-validated thresholds as highly
      aggressive disease comparing 18F-DOPA uptake and relative cerebral blood volume (relCBV) from
      perfusion MRI (pMRI) as well as differences in RT volumes identified using biopsy-validated
      thresholds as tumor extent comparing 18F-DOPA uptake and diffusion maps from diffusion tensor
      imaging (DTI) will be evaluated.

      III. Evaluate quality of life after radiotherapy using European Organization for Research and
      Treatment of Cancer (EORTC) questionnaires compared with historical controls from
      Keim-Guibert et al.

      IV. Compare differences in proton radiation planning utilizing radiobiologic
      modeling/evaluation techniques performed at Mayo Clinic Rochester to linear energy transfer
      distribution evaluation at Mayo Clinic Arizona.

      OUTLINE:

      Patients receive 18F-DOPA intravenously (IV) and undergo PET/MRI or PET/CT imaging scan.
      Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding
      weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients
      receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28
      days for up to 7 cycles in the in the absence of disease progression or unacceptable
      toxicity.

      After completion of study treatment, patients are followed up every 2 months for 1 year, and
      then periodically for up to 5 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival (OS)
time frame: Time from registration to death due to any cause, assessed up to 12 months
description: The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated utilizing exact binomial methodology. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).
measure: Progression free survival
time frame: At 12 months after radiation therapy
description: The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated utilizing exact binomial methodology.
measure: Progression Free Survival
time frame: Time from registration to the earliest date documenting disease progression, assessed up to 5 years
description: The distribution of progression free survival times groups will be estimated using the method of Kaplan-Meier (1958).
measure: Incidence of adverse events (AEs)
time frame: Up to 5 years post treatment
description: The rate of acute and late treatment-related toxicities for newly diagnosed high-grade glioma patients treated with fluorodopa F 18-positron emission tomography (18F-DOPA PET) image-guided hypofractionated proton beam therapy will be determined, with acute radiotherapy (RT) toxicities graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
measure: Radiotherapy (RT) treatment volumes
time frame: Up to 5 years post treatment
description: Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between treatment volumes defined by magnetic resonance (MR) only and treatment volumes defined with both positron emission tomography (PET) and MR information.
measure: Quality of life (QOL)
time frame: Up to 5 years post treatment
description: QOL surveys will be compared to data from historical controls. Quality of life will be assessed at baseline and at each magnetic resonance imaging (MRI) evaluation (up to 6 evaluations). QOL will be measured using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30.
measure: Differences in proton radiation planning
time frame: Up to 5 years post treatment
description: Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between proton plan metrics based off the two modeling/evaluation techniques.
arm group label: Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
arm group type: Experimental
description: Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.
intervention type: Procedure
intervention name: Computed Tomography
description: Undergo PET/CT
arm group label: Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
other name: CAT
other name: CAT Scan
other name: Computerized Axial Tomography
other name: Computerized Tomography
other name: CT
other name: CT Scan
other name: tomography
intervention type: Other
intervention name: Fluorodopa F 18
description: Given IV
arm group label: Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
other name: (18F)FDOPA
other name: 18F-DOPA
other name: 18F-FDOPA
other name: 3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanine
other name: 6-(18F)Fluoro-L-DOPA
other name: Fluorine F 18 Fluorodopa
other name: Fluorine-18-fluoro-L-DOPA
other name: Fluorodopa (18F)
other name: FLUORODOPA F-18
other name: L-6-(18F)Fluoro-DOPA
intervention type: Procedure
intervention name: Magnetic Resonance Imaging
description: Undergo PET/MRI
arm group label: Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
other name: Magnetic Resonance Imaging Scan
other name: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
other name: MR Imaging
other name: MRI
other name: MRI Scan
other name: NMR Imaging
other name: NMRI
other name: Nuclear Magnetic Resonance Imaging
intervention type: Procedure
intervention name: Positron Emission Tomography
description: Undergo PET/CT or PET/MRI
arm group label: Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
other name: Medical Imaging, Positron Emission Tomography
other name: PET
other name: PET Scan
other name: Positron Emission Tomography Scan
other name: Positron-Emission Tomography
other name: proton magnetic resonance spectroscopic imaging
intervention type: Radiation
intervention name: Proton Beam Radiation Therapy
description: Receive proton beam RT
arm group label: Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
other name: PBRT
other name: Proton
other name: Proton Radiation Therapy
other name: Radiation, Proton Beam
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
intervention type: Drug
intervention name: Temozolomide
description: Drug
arm group label: Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
other name: CCRG-81045
other name: Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
other name: M & B 39831
other name: M and B 39831
other name: Methazolastone
other name: RP-46161
other name: SCH 52365
other name: Temcad
other name: Temodal
other name: Temodar
other name: Temomedac
other name: TMZ
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Sujay A Vora
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Glioma
mesh term: Temozolomide
mesh term: Levodopa
mesh term: Fluorides