68-Ga-FAPI PET Imaging in Malignancy

NCT04023240 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: IRB-52129VAR0195
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility trial studies the use of gallium-68 (68Ga)-FAPI as the imaging agent for positron emission tomography (PET)/computed tomography (CT), collectively PET/CT, in patients with various cancers. PET uses a radioactive substance called 68Ga-FAPI, which attaches to cancer activated fibroblasts. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy tissue. CT uses X-rays to make a picture of areas inside the body. Using 68Ga-FAPI in diagnostic procedures, such as PET/CT, may allow doctors to identify smaller tumors than standard imaging.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of 68Ga-FAPI PET

  Feasibility of 68Ga-FAPI PET/CT imaging will be done to assess patients with malignancy. Feasibility will be measured using Likert scale (1-non diagnostic; 5-excellent; anything 3 or more is diagnostic). The study will be feasible if \> 50% of scans will have a score of 3 or more

  24 months

Study Arms (1)

68Ga-FAPI PET/CT

EXPERIMENTAL

Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later.

Drug: 68Ga-FAPI; Procedure: Computed Tomography (CT) scan; Procedure: Positron Emission Tomography (PET) scan

Interventions

68Ga-FAPI DRUG

68Ga-FAPI is quinoline based PET radiopharmaceutical. 68Ga-FAPI is administered intravenously (IV)

Also known as: 68-Ga-Fibroblast activation protein inhibitor (FAPI)

68Ga-FAPI PET/CT

Computed Tomography (CT) scan PROCEDURE

Participants will have a CT scan for attenuation correction and anatomic localization of PET data.

68Ga-FAPI PET/CT

Positron Emission Tomography (PET) scan PROCEDURE

PET images will be acquired.

68Ga-FAPI PET/CT

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with current malignancy confirmed via pathology or imaging
• Patient must be \> 18 years old
• Patient must be willing and able to provide written informed consent for the trial
• Patient of reproductive potential will have a pregnancy test

You may not qualify if:

• Pregnant or breastfeeding

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

68Ga-FAPI; Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Carina A Mari, MD

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: July 1, 2023
• Primary Completion: July 14, 2023
• Study Completion: December 14, 2023
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)