Study to Determine the Impact of Advanced Magnetic Resonance Imaging (MRI) Using 18F-DOPA (a chemical tracer that highlights certain cells during imaging) During Planning for Proton Beam Radiation Therapy.

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 17-007458
    • Scottsdale/Phoenix, Arizona: 17-007458
    NCT ID: NCT03778294
    Sponsor Protocol Number: MC1774

About this study

The purpose of this study is to utilize a novel approach of combining advanced radiation delivery with proton beam therapy with advanced tumor visualization with 18F-DOPA PET and MRI imaging. We will study the effectiveness and safety of this technique delivering the entire treatment over 1-2 weeks.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  •  Age ≥70 years.
  •  Histologically confirmed newly diagnosed Grade IV malignant glioma.
  •  Planned radiation treatments at Mayo Clinic Arizona or Mayo Clinic Rochester.
  •  Willing to sign release of information for any radiation and/or follow-up records.
  •  Provide informed written consent.
  •  Patients with eGFR ≥ 60 mg/min/1.72m2.
  •  Ability to complete questionnaire(s) by themselves or with assistance.
  •   ECOG performance status 0, 1, 2.

Exclusion Criteria:

  • Patients diagnosed with Grades I-III glioma.
  • Currently on Avastin at time of treatment.
  • Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure).
  • Unable to undergo an 18F-DOPA-PET scan (e.g. Parkinson’s Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists).
    • NOTE: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline. If a patient is on any of these drugs, list which ones on the On-Study form.
  • Pregnant women, nursing women, or men or women of childbearing potential who are unwilling to employ adequate contraception.
    • NOTE: All women enrolled in this study will be age 70 or over, and at the determination of the PI, will not be of childbearing potential.  If the radiology department requires a pregnancy test before administering the 18FDOPA injection, they may perform one per their standard of care.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nadia Laack, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Sujay Vora, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20446102

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