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

Malignant Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02104310
• Other study ID #: 11-002165
• Status: Active, not recruiting
• Start date: April 2014
• Est. completion date: March 2031

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: March 2031
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma

Intervention

Drug:
• Fluorine-18-L-dihydroxyphenylalanine
5 millicuries ± 10%; Intravenous injection; 1 time

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Brains Together for the Cure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment volume comparison	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	6 weeks
Secondary	Advanced imaging volume comparison	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	6 weeks
Secondary	Concordance with recurrence	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	up to 10 years

External Links

•   Mayo Clinic Clinical Trials