Phase 2 N=43 Treatment

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

Glioblastoma · Malignant Glioma

Bottom Line

View on ClinicalTrials.gov: NCT03778294 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Overall Survival (OS) — 0.54 proportion of successes

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Computed Tomography (Procedure); Fluorodopa F 18 (Other); Magnetic Resonance Imaging (Procedure); Positron Emission Tomography (Procedure); Proton Beam Radiation Therapy (Radiation); Quality-of-Life Assessment (Other); Questionnaire Administration (Other); Temozolomide (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival (OS)	0.54	—
SECONDARY Progression Free Survival	6.9	—
SECONDARY Progression Free Survival	6.9	—
SECONDARY Incidence of Adverse Events (AEs)	34; 18; 5; 27; 7; 0	—

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 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.

Eligibility Criteria

Inclusion Criteria

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 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03778294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.