Status:
COMPLETED
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
Lead Sponsor:
Mayo Clinic
Conditions:
Glioblastoma
Malignant Glioma
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
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 mal...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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 estimated glomerular filtration rate (eGFR) \>= 60 mg/min/1.72 m\^2
- Ability to complete questionnaire(s) by themselves or with assistance
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
Exclusion
- 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 65 or over, and at the determination of the principal investigator (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
Key Trial Info
Start Date :
March 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03778294
Start Date
March 28 2019
End Date
November 26 2023
Last Update
July 3 2025
Active Locations (2)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905