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F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery

Study Purpose

This early phase I trial studies how well F18 fluciclovine positron emission tomography (PET)/computed tomography (CT) works in assessing tumor volume and radiation therapy response in patients with glioblastoma undergoing surgery. Radioactive imaging agents, such as F18 fluciclovine, used during PET/CT scan may help measure tumor size compared to standard of care magnetic resonance imaging (MRI) contrast agents in patients receiving radiation therapy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patient is a candidate for brain tumor resection and radiation with lesion suspected to be or previously biopsy proven to be a glioblastoma.
  • - Patient is able to understand and give consent to participation in the study.

Exclusion Criteria:

  • - Pregnant.
  • - Known allergy to gadolinium-based contrast agents or F18 fluciclovine.
  • - Renal failure as evidenced by a glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m^2.
  • - Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to: - Electronically, magnetically, and mechanically activated implants.
  • - Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers.
  • - Metallic splinters in the eye.
  • - Ferromagnetic hemostatic clips in the central nervous system (CNS) or body.
  • - Cochlear implants.
  • - Other pacemakers, e.g., for the carotid sinus.
  • - Insulin pumps and nerve stimulators.
  • - Non-MR safe lead wires.
  • - Prosthetic heart valves (if dehiscence is suspected) - Non-ferromagnetic stapedial implants.
  • - Pregnancy.
  • - Claustrophobia that does not readily respond to oral medication.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03926507
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jason M Johnson
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Study Website: View Trial Website
Additional Details

PRIMARY OBJECTIVES:

  • I. To compare fluciclovine F18 (F18 fluciclovine) PET CT for tumor volume assessment compared to T2 fluid attenuated inversion recovery (FLAIR) and T1 post contrast magnetic resonance (MR) brain imaging.
SECONDARY OBJECTIVES:
  • I. To assess changes in F18 fluciclovine defined disease with surgery and radiation.
  • II. To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity.
EXPLORATORY OBJECTIVES:
  • I. To assess the association between results from pathology and F18 fluciclovine, T2 FLAIR, and T1 post-contrast MR brain imaging.
OUTLINE: Patients receive fluciclovine F18 intravenously (IV) and undergo 4 PET/CT scans over 10 minutes paired with standard of care MRI within 14 days prior to initial maximal tumor resection, within 7 days prior to initiation of radiation therapy, 28 days after the completion of radiation therapy, and 6 months after the completion of radiation therapy. After completion of study, patients will be followed up at 3 and 6 months.

Arms & Interventions

Arms

Experimental: Diagnostic (fluciclovine F18 PET/CT)

Patients receive fluciclovine F18 IV and undergo 4 PET/CT scans over 10 minutes paired with standard of care MRI within 14 days prior to initial maximal tumor resection, within 7 days prior to initiation of radiation therapy, 28 days after the completion of radiation therapy, and 6 months after the completion of radiation therapy.

Interventions

Procedure: - Computed Tomography

Undergo PET/CT scan

Other: - Fluciclovine F18

Given IV

Procedure: - Positron Emission Tomography

Undergo PET/CT scan

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Address

M D Anderson Cancer Center

Houston, Texas, 77030

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