NCT02104310

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
59mo left

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Apr 2014Mar 2031

First Submitted

Initial submission to the registry

April 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2021

Completed
9.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Expected
Last Updated

October 31, 2025

Status Verified

October 1, 2025

Enrollment Period

7 years

First QC Date

April 1, 2014

Last Update Submit

October 29, 2025

Conditions

Malignant Glioma

Keywords

malignant gliomaFDOPAPET CTradiation therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Advanced imaging volume comparison

    6 weeks

  • Concordance with recurrence

    up to 10 years

Study Arms (1)

Fluorine-18-L-dihydroxyphenylalanine

18F-DOPA PET imaging will be used to guide radiotherapy treatment volumes and patients will be followed post-treatment to analyze response and patterns of failure

Drug: Fluorine-18-L-dihydroxyphenylalanine

Interventions

Fluorine-18-L-dihydroxyphenylalanineDRUG

5 millicuries ± 10%; Intravenous injection; 1 time

Also known as: 18F-DOPA, FDOPA
Fluorine-18-L-dihydroxyphenylalanine

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Newly diagnosed or recurrent WHO Grade II and Grade III Glioma patients.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Glioma

Interventions

fluorodopa F 18

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Nadia N Laack, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Debra Brinkmann, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Deanna Pafundi, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 4, 2014

Study Start

April 1, 2014

Primary Completion

March 26, 2021

Study Completion (Estimated)

March 1, 2031

Last Updated

October 31, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)