18F-DOPA-PET in Finding Tumors in Patients With Newly Diagnosed Gliomas Undergoing Radiation Therapy

NCT01991977 | Completed Phase 2 Results DMC

• 3 other identifiers: MC1374NCI-2013-0224213-005106
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well fluorine F 18 fluorodopa (18F-DOPA)-positron emission tomography (PET) works in finding tumors in patients with newly diagnosed gliomas undergoing radiation therapy. Comparing results of diagnostic procedures done before and during radiation therapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Conditions

Malignant Glioma

Outcome Measures

Primary Outcomes (1)

• Proportion of Grade IV MGMT Un-methylated Patients That Experience Confirmed-progression-free Survival at 6 Months (CPFS6)

  The proportion of Grade IV MGMT un-methylated patients that experience confirmed-progression-free survival at 6 months (CPFS6). Progression is defined by any of the following: * ≥25% increase in the sum of products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids * Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events * Any new lesion * Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose. * Failure to return for evaluation due to death or deteriorating condition * Clear progression of non-measurable disease

  Time from registration to the confirmed disease progression, assessed at 6 months

Secondary Outcomes (5)

• Overall Survival

  Up to 5 years

• Progression Free Survival

  Up to 5 years

• Quality of Life Evaluated With the M. D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Questionnaire

  Up to 5 years

• Number of Patients Experiencing Grade 3+ Treatment-related Toxicities

  Up to 5 years

• Number of Patients Experiencing Grade 4+ Late Treatment-related Toxicities

  Up to 5 years

Other Outcomes (9)

• Inter-observer Variability With or Without the Addition of 18F-DOPA Positron Emission Tomography Uptake for Radiotherapy Target Volume Delineation

  Up to 5 years

• Intra-observer Variability With or Without the Addition of 18F-DOPA Positron Emission Tomography Uptake for Radiotherapy Target Volume Delineation

  Up to 5 years

• Magnetic Resonance Imaging-only Defined Volumes and the Volumes Defined With the Combination of Magnetic Resonance and Positron Emission Tomography Planning

  Up to 5 years

Study Arms (1)

Diagnostic (PET, pMRI, DTI, IMRT, temozolomide)

EXPERIMENTAL

Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.

Procedure: Diffusion Weighted Imaging; Drug: Fluorine F 18 Fluorodopa; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Perfusion Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Drug: Temozolomide

Interventions

Diffusion Weighted Imaging PROCEDURE

Undergo DTI

Also known as: Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRI, DWI, DWI MRI, DWI-MRI, MR Diffusion-Weighted Imaging

Diagnostic (PET, pMRI, DTI, IMRT, temozolomide)

Fluorine F 18 Fluorodopa DRUG

Undergo 18F-DOPA-PET

Also known as: 18F-FDOPA

Diagnostic (PET, pMRI, DTI, IMRT, temozolomide)

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

Diagnostic (PET, pMRI, DTI, IMRT, temozolomide)

Perfusion Magnetic Resonance Imaging PROCEDURE

Undergo pMRI

Also known as: magnetic resonance perfusion imaging

Diagnostic (PET, pMRI, DTI, IMRT, temozolomide)

Positron Emission Tomography PROCEDURE

Undergo 18F-DOPA-PET

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

Diagnostic (PET, pMRI, DTI, IMRT, temozolomide)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Diagnostic (PET, pMRI, DTI, IMRT, temozolomide)

Temozolomide DRUG

Receive temozolomide

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

Diagnostic (PET, pMRI, DTI, IMRT, temozolomide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed newly diagnosed grade IV malignant glioma; Note: grade III patients are no longer being enrolled
• Computed tomography (CT) simulation, immobilization, MRI and PET imaging, treatment planning, and all follow-up MRI and PET scans to be performed at Mayo Clinic Rochester; Note: the actual radiation therapy treatments and follow-up other than imaging can be performed at Mayo Clinic Rochester, Northfield, LaCrosse, Mankato, Eau Claire, or Albert Lea
• Provide written informed consent
• Ability to complete questionnaire(s) by themselves or with assistance

You may not qualify if:

• Patients diagnosed with anaplastic oligodendroglioma
• 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 consist of: amoxapine, amphetamine, benztropine, bupropion, 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
• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Laack NN, Pafundi D, Anderson SK, Kaufmann T, Lowe V, Hunt C, Vogen D, Yan E, Sarkaria J, Brown P, Kizilbash S, Uhm J, Ruff M, Zakhary M, Zhang Y, Seaberg M, Wan Chan Tseung HS, Kabat B, Kemp B, Brinkmann D. Initial Results of a Phase 2 Trial of 18F-DOPA PET-Guided Dose-Escalated Radiation Therapy for Glioblastoma. Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1383-1395. doi: 10.1016/j.ijrobp.2021.03.032. Epub 2021 Mar 23.

  PMID: 33771703 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Glioma

Interventions

fluorodopa F 18; Radiotherapy, Intensity-Modulated; Magnetic Resonance Spectroscopy; Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Nadia N. Laack, MD
• Organization: Mayo Clinic

Laack.Nadia@mayo.edu

507/284-2511

Study Officials

• Debra H. Brinkmann, Ph.,D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

• Nadia N. Laack, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2019
• Study Completion: July 15, 2024
• Last Updated: October 20, 2025
• Results First Posted: April 3, 2020

Record last verified: 2025-04

Locations

US (1)