Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm

NCT06474533 | Recruiting DMC FDA Drug

• 2 other identifiers: 24924NCI-2024-04996
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracranial Neoplasm

Keywords

Imaging Studies

Outcome Measures

Primary Outcomes (3)

• Maximum Intracranial lesion tumor-to-background ratio (TBRmax)

  The maximum TBR (TBRmax) will be calculated by dividing the SUVmean of the 1.6 centimeter (cm) diameter circular region of interest (ROI) by the mean standardized uptake value (SUVmean) of background normal tissue.

  Up to 3 years

• Percentage of accurate prediction of presence of tumor (Population 1)

  The percentage of radiological read responses that accurately predict the presence of recurrent tumor in patients previously treated with surgery and/or radiation for population 1, broken down by metastatic disease, high-grade gliomas and low-grade gliomas will be reported

  Up to 3 years

• Percentage of radiological read responses

  The percentage of radiological reads with a binary characterization of scan study as positive for recurrence disease in population 1, and positive for high-grade glial neoplasm in population 2 will be reported.

  Up to 3 years

Study Arms (2)

Population 1: Participants with intracranial neoplasms

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

Drug: Fluorethyltyrosine (18-F); Procedure: Positron Emission Tomography (PET)

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)

Drug: Fluorethyltyrosine (18-F); Procedure: Positron Emission Tomography (PET)

Interventions

Fluorethyltyrosine (18-F) DRUG

Given intravenously (IV)

Also known as: Fluoroethyltyrosine (FET), FET, O-(2-[18F]fluoroethyl)-L-tyrosine (FET)

Population 1: Participants with intracranial neoplasms; Population 2: Participants with suspected glial neoplasms

Positron Emission Tomography (PET) PROCEDURE

Undergo Imaging Procedure

Also known as: PET scan, PET

Population 1: Participants with intracranial neoplasms; Population 2: Participants with suspected glial neoplasms

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults and children over the age of 3 with intracranial neoplasms (glial or metastatic disease).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Hope: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Fluorine-18; (18F)fluoroethyltyrosine; O-(2-fluoroethyl)tyrosine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Javier Villanueva-Meyer, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Magat

CONTACT

(415) 502-1822; Louise.Magat@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Principal Investigator, IND Holder

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)