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

Not Applicable

Recruiting

• Conditions: Anal Carcinoma; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Cholangiocarcinoma; Colorectal Carcinoma; Esophageal Carcinoma; Gastric Carcinoma; Head and Neck Carcinoma; Hematopoietic and Lymphatic System Neoplasm

• Registration Number: NCT07118176
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

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.

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 Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Primary Completion: 2026-09-06
• Study Completion: 2027-09-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46)	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.

Secondary Outcome Measures

Name	Time	Method
Fludeoxyglucose F-18 (18F-FDG) biodistribution	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-.

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States