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Active, Not Recruiting

NCT Number: NCT02104310

A Pilot Study Using 18F-DOPA PET-guided Radiotherapy in Gliomas

For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used. This type of scan has shown promise in being able to better distinguish tumor from normal brain tissue and may help to more accurately plan radiation treatment. This type of scan can also assist the radiation oncologist in identifying the most aggressive regions of the tumor. The goal of this study is to compare the 18F-DOPA PET/CT scan with the MRI scan for identifying where the disease is that needs to be treated with radiation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥7 years.
  • Biopsy confirmed newly diagnosed or recurrent WHO Grade II or Grade III malignant glioma.
  • CT simulation, 18F-DOPA PET imaging, and standard of care pre-radiotherapy MRI scans to be performed at Mayo Clinic Rochester.
  • Willing to sign release of information for any follow-up records.
  • Provide informed written consent.

Exclusion criteria

  • Patients diagnosed with WHO grade IV malignant glioma.
  • Patients previously treated with radiation therapy.
  • 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)
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception

Treatment and study plan

Fluorine-18-L-dihydroxyphenylalanine

Drug

5 millicuries ± 10%; Intravenous injection; 1 time

Other names: 18F-DOPA, FDOPA

Primary outcomes

  1. Treatment volume comparison

    Time frame: 6 weeks

    The primary endpoint for this pilot study will be to compare radiotherapy treatment volumes defined by conventional MR-only with treatment volumes defined with both 18F-DOPA PET and conventional MR information

Secondary outcomes

  1. Advanced imaging volume comparison

    Time frame: 6 weeks

    For patients who have advanced MRI scans performed as part of standard clinical care, advanced MRI volumes will be compared with conventional MRI volumes as well as 18F-DOPA PET volumes

  2. Concordance with recurrence

    Time frame: up to 10 years

    For patients who progress radiographically within the observation period of this study will compare concordance of recurrence locations with pre-treatment 18F-DOPA PET uptake

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Brains Together for the Cure

Registry information

Official study title

A Pilot Study Evaluating the Utility of 18F-DOPA PET for Radiotherapy Treatment Planning of Malignant Glioma Patients

Important dates

Study start
2014
Primary completion
2021
Study completion
2031
First posted
Apr 4, 2014
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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