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

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ClinicalTrials.gov Identifier: NCT02104310
Recruitment Status : Active, not recruiting
First Posted : April 4, 2014
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
Brains Together for the Cure
Information provided by (Responsible Party):
Debra H. Brinkmann, Ph.D., Mayo Clinic

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 to image the tumor and guide your radiation oncologist in determining locations to treat with radiation. 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 use the 18F-DOPA PET/CT scan to help determine where the disease is that needs to be treated with radiation, in order to improve the effectiveness of radiation in this tumor.

Condition or disease Intervention/treatment Phase
Malignant Glioma Drug: Fluorine-18-L-dihydroxyphenylalanine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating the Utility of 18F-DOPA PET for Radiotherapy Treatment Planning of Malignant Glioma Patients
Actual Study Start Date : April 2014
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
5 millicuries ± 10%; Intravenous injection; 1 time
Other Names:
  • 18F-DOPA
  • FDOPA




Primary Outcome Measures :
  1. Reduce non-central failure rates [ Time Frame: tumor progression or up to 5 years ]
    The primary endpoint for this pilot study is the proportion of WHO grade III astrocytoma or oligoastrocytoma patients that progress with any non-central failure.


Secondary Outcome Measures :
  1. Time to progression [ Time Frame: 36 months from the start of radiotherapy ]
    The trial aims to show improvement in 36-month progression free survival outcomes compared to historical controls

  2. Time to death [ Time Frame: 36 months after radiotherapy ]
    The trial aims to show improvement in 36 month overall survival compared to historical controls

  3. Number of patients with acute serious and non-serious adverse events [ Time Frame: 6 weeks ]
    Patients will be evaluated to ensure the number of serious and non-serious adverse events are not higher than historical controls

  4. Number of patients with late serious and non-serious adverse events [ Time Frame: up to 5 years ]
    Evaluate the number of late serious and non-serious adverse events compared to historical controls



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years.
  • Biopsy confirmed newly diagnosed or recurrent WHO Grade II or Grade III malignant glioma, or Grade III malignant astrocytoma or oligoastrocytoma.
  • Planned radiation treatments at Mayo Clinic Rochester.
  • Willing to sign release of information for any follow-up records.
  • Provide informed written consent.
  • Willingness to participate in mandatory pre- and post-treatment imaging studies.

Exclusion Criteria:

  • Patients diagnosed with WHO grade III oligodendroglioma or 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104310


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Brains Together for the Cure
Investigators
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Principal Investigator: Nadia N Laack, MD Mayo Clinic
Principal Investigator: Debra Brinkmann, PhD Mayo Clinic
Principal Investigator: Deanna Pafundi, PhD Mayo Clinic

Additional Information:
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Responsible Party: Debra H. Brinkmann, Ph.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02104310     History of Changes
Other Study ID Numbers: 11-002165
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Debra H. Brinkmann, Ph.D., Mayo Clinic:
malignant glioma
FDOPA
PET CT
radiation therapy
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Dihydroxyphenylalanine
Fluorides
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cariostatic Agents
Protective Agents