Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers

August 5, 2025 updated by: Jonsson Comprehensive Cancer Center

PET Imaging Study of 68Ga-FAPI-46 Biodistribution in Cancer Patients

This phase I trial is evaluating a new imaging tracer (68Ga-FAPi-46) with positron emission tomography (PET)/computed tomography (CT) to determine where and to which degree the tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues (the biodistribution) in patients with solid tumors or hematologic (blood) cancers. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-FAPi-46. Because some cancers take up 68Ga-FAPi-46, it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in a patient's body. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To define the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies measured by standardized uptake values (SUV).

SECONDARY OBJECTIVE:

I. To assess the 68Ga-FAPI-46 biodistribution correlation with fludeoxyglucose F-18 (18F-FDG) biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).

OUTLINE:

Patients receive 68Ga-FAPi-46 intravenously (IV) and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA / Jonsson Comprehensive Cancer Center
        • Principal Investigator:
          • Jeremie Calais
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with the following suspected or diagnosed cancer types:

    • Adrenal cancer
    • Anal cancer
    • Bladder cancer
    • Brain cancer
    • Breast cancer
    • Cancer of unknown primary (CUP)
    • Cervical cancer
    • Cholangiocarcinoma
    • Colorectal cancer
    • Esophageal cancer
    • Gastric cancer
    • Head and neck cancer
    • Hematologic cancer
    • Hepatocellular carcinoma
    • Lung cancer
    • Medullary thyroid cancer
    • Neuroendocrine neoplasias
    • Ovarian cancer
    • Pancreatic cancer
    • Penile cancer
    • Peritoneal cancer
    • Pleural cancer
    • Prostate cancer
    • Sarcoma
    • Salivary gland cancer
    • Solitary fibrous tumor
    • Skin cancer
    • Testicular cancer
    • Thymus cancer
    • Thyroid cancer
    • Urothelial cancer
    • Uterus cancer
    • Vaginal cancer
  • Patients are ≥ 18 years old at the time of the radiotracer administration
  • Patient can provide written informed consent
  • Patient is able to remain still for duration of imaging procedure (up to one hour)

Exclusion Criteria:

  • Patient is pregnant or nursing
  • Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high-quality data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (68Ga-FAPi-46 PET/CT)
Patients receive 68Ga-FAPi-46 IV and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Other: Fludeoxyglucose F-18
Given IV
Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose (18F)
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18
Radiation: Gallium Ga 68 FAPi-46
Given IV
Other Names:
  • 68Ga-FAPi-46
  • (68GA)Ga-FAPI-46
  • FAPI-46 GA-68
  • Gallium-68-FAPI-46

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46)
Time Frame: Up to 2 years
Will be evaluated in normal and cancer tissues by standardized uptake values to determine where and to which degree 68Ga-FAPi-46 accumulates in normal and cancer tissues.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fludeoxyglucose F-18 (18F-FDG) biodistribution
Time Frame: Up to 2 years
Will assess the correlation between 68Ga-FAPi-46 biodistribution and 18F-FDG biodistribution and define the frequency of the following phenotypes: 68Ga-FAPi-46 (FAP)+/fludeoxyglucose F-18 (FDG)+, FAP-/FDG+, FAP+/FDG-, FAP-/FDG-.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

  • Principal Investigator: Jeremie Calais, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

September 6, 2026

Study Completion (Estimated)

September 7, 2027

Study Registration Dates

First Submitted

August 5, 2025

First Submitted That Met QC Criteria

August 5, 2025

First Posted (Actual)

August 12, 2025

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-0201
  • NCI-2025-04961 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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