Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm

Study Purpose

This is a single center study investigating the use of Fluoroethyltyrosine (FET) in the detection of brain tumors. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize grade of glial neoplasms.

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.	Observational
Eligible Ages	4 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Presence or suspicion of intracranial neoplasm in two populations: - Population 1: Participants after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on MRI.

- Three sub-populations will be considered: - Recurrent metastatic lesions.

- Recurrent high-grade gliomas (Grades 3 and 4).

- Recurrent low-grade gliomas (Grade 2).

- Population 2: Participants prior to primary treatment with planned biopsy or surgical resection.

- Age > 3 years.

Participants in other clinical trials will be eligible for this study including patients undergoing surgery guided by 5-aminolevulinic acid.

Exclusion Criteria:

- Participants with known incompatibility to PET or Computerized tomography (CT)/magnetic resonance imaging (MRI) scans.

- Participants unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

- Sedation or anesthesia can be used for participants who cannot tolerate the exam.

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.	NCT06474533
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.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Thomas Hope
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Javier Villanueva-Meyer, MD
Principal Investigator Affiliation	University of California, San Francisco
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Intracranial Neoplasm

Additional Details

PRIMARY OBJECTIVES: 1. To determine if FET Positron Emission Tomography (PET) scan can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent metastatic disease and high-grade gliomas. 2. To determine if FET PET scan can differentiate between low-grade and high-grade gliomas in population 2. SECONDARY OBJECTIVES: 1. To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology or imaging follow-up in population 1. 2. To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology in population 1 with recurrent low-grade gliomas. EXPLORATORY OBJECTIVES: 1. To assess relationships between serial FET PET scan and clinical outcome in population 1 with recurrent metastatic disease and gliomas. OUTLINE: Participants will receive a single PET scan lasting for about 40 minutes in an outpatient setting after an injection with FET. Adult participants may undergo up to two repeat FET PET scans. Adverse events will be recorded.

Arms & Interventions

Arms

: Population 1: Participants with intracranial neoplasms

Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging.

: Population 2: Participants with suspected glial neoplasms

Participants with suspected glial neoplasms (Grade 2 - 4) planning to undergo biopsy or surgery prior to non-investigational, standard-of-care, primary treatment (radiation therapy and/or surgery)

Interventions

Drug: - Fluorethyltyrosine (18-F)

Given intravenously (IV)

Procedure: - Positron Emission Tomography (PET)

Undergo Imaging Procedure

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.

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94143

Site Contact

Louise Magat

[email protected]

415-502-1822

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