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

NCT03778294 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: MC1774NCI-2018-0280017-007458
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Glioblastoma; Malignant Glioma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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).

  Time from registration to death due to any cause, assessed up to 12 months

Secondary Outcomes (3)

• Progression Free Survival

  At 12 months after radiation therapy

• Progression Free Survival

  Up to 4 years

• Incidence of Adverse Events (AEs)

  Up to 4 years

Other Outcomes (3)

• Radiotherapy (RT) Treatment Volumes

  Up to 5 years post treatment

• Quality of Life (QOL)

  Up to 5 years post treatment

• Differences in Proton Radiation Planning

  Up to 5 years post treatment

Study Arms (1)

Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)

EXPERIMENTAL

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.

Procedure: Computed Tomography; Other: Fluorodopa F 18; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Temozolomide

Interventions

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)

Fluorodopa F 18 OTHER

Given IV

Also known as: (18F)FDOPA, 18F-DOPA, 18F-FDOPA, 3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanine, 6-(18F)Fluoro-L-DOPA, Fluorine F 18 Fluorodopa, Fluorine-18-fluoro-L-DOPA, Fluorodopa (18F), FLUORODOPA F-18, L-6-(18F)Fluoro-DOPA

Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)

Magnetic Resonance Imaging PROCEDURE

Undergo PET/MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)

Positron Emission Tomography PROCEDURE

Undergo PET/CT or PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)

Proton Beam Radiation Therapy RADIATION

Receive proton beam RT

Also known as: PBRT, Proton, Proton Radiation Therapy, Radiation, Proton Beam

Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)

Questionnaire Administration OTHER

Ancillary studies

Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)

Temozolomide DRUG

Drug

Also known as: CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac, TMZ

Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Vora S, Pafundi D, Voss M, Buras M, Ashman J, Bendok B, Breen W, Hu L, Kizilbash S, Laack N, Liu W, Mahajan A, Mrugala M, Porter A, Ruff M, Sio T, Uhm J, Yang M, Brinkmann D, Brown P. Short-course hypofractionated proton beam therapy, incorporating 18F-DOPA PET and contrast-enhanced MRI targeting, for patients aged 65 years and older with newly diagnosed glioblastoma: a single-arm phase 2 trial. Lancet Oncol. 2024 Dec;25(12):1625-1634. doi: 10.1016/S1470-2045(24)00585-0. Epub 2024 Nov 18.

  PMID: 39571596 DERIVED

MeSH Terms

Conditions

Glioblastoma; Glioma

Interventions

fluorodopa F 18; Magnetic Resonance Spectroscopy; Proton Therapy; Protons; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Heavy Ion Radiotherapy; Radiotherapy; Therapeutics; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr Sujay Vora
• Organization: Mayo Clinic

Vora.Sujay@mayo.edu

480-342-1262

Study Officials

• Sujay A Vora

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 19, 2018
• Study Start: March 28, 2019
• Primary Completion: June 30, 2022
• Study Completion: November 26, 2023
• Last Updated: July 3, 2025
• Results First Posted: November 14, 2023

Record last verified: 2023-12

Locations

US (2)