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Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)

Study Purpose

An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After 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:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 2. Previous history of solid tumor brain metastasis of any origin. 3. Histopathological confirmation of the primary solid tumor or a metastatic site. 4. Previous radiation therapy of brain metastatic lesion(s) 5. A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis. 6. Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for craniotomy.

Exclusion Criteria:

1. Patients with a history of active hematological malignancy

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.

NCT04410367
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.

Phase 2
Lead Sponsor

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

Blue Earth Diagnostics
Principal Investigator

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

Eugene Teoh, MDRupesh Kotecha, MD
Principal Investigator Affiliation Blue Earth DiagnosticsMiami Cancer Institute
Agency Class

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

Industry
Overall Status Completed
Countries United States
Conditions

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

Brain Metastases
Arms & Interventions

Arms

Experimental: Patients

Single intravenous administration of 18F fluciclovine for PET Scan

Interventions

Drug: - 18F fluciclovine

18F fluciclovine injection, 185 MegaBecquerel (MBq) (5 Millicurie (mCi)) ± 20%, delivered as an intravenous bolus

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.

Santa Monica, California

Status

Address

John Wayne Cancer Institute at Providence St. John's Health Center

Santa Monica, California, 90404

Yale School of Medicine, New Haven, Connecticut

Status

Address

Yale School of Medicine

New Haven, Connecticut, 06519

Miami Cancer Institute, Miami, Florida

Status

Address

Miami Cancer Institute

Miami, Florida, 33176

Ochsner Clinic Foundation, New Orleans, Louisiana

Status

Address

Ochsner Clinic Foundation

New Orleans, Louisiana, 70131

Saint Louis, Missouri

Status

Address

Washington University School of Medicine Center for Clinical Imaging Research

Saint Louis, Missouri, 63110

NYU Langone Health, New York, New York

Status

Address

NYU Langone Health

New York, New York, 10016

University Hospital Cleveland, Cleveland, Ohio

Status

Address

University Hospital Cleveland

Cleveland, Ohio, 44106

University of Pennsylvania Health System, Philadelphia, Pennsylvania

Status

Address

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104

Salt Lake City, Utah

Status

Address

Center for Quantitative Cancer Imaging at Huntsman Cancer Institute

Salt Lake City, Utah, 84112