NCT07118176

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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
• Hepatocellular Carcinoma
• Lung Carcinoma
• Malignant Adrenal Gland Neoplasm
• Malignant Brain Neoplasm
• Malignant Neoplasm of Unknown Primary
• Malignant Solid Neoplasm
• Malignant Testicular Neoplasm
• Malignant Uterine Neoplasm
• Neuroendocrine Neoplasm
• Ovarian Carcinoma
• Pancreatic Carcinoma
• Penile Carcinoma
• Pleural Carcinomatosis
• Primary Peritoneal Carcinoma
• Prostate Carcinoma
• Salivary Gland Carcinoma
• Sarcoma
• Skin Carcinoma
• Solitary Fibrous Tumor
• Thymus Carcinoma
• Thyroid Gland Carcinoma
• Thyroid Gland Medullary Carcinoma
• Urothelial Carcinoma
• Vaginal Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT
OTHER	Fludeoxyglucose F-18	Given IV
RADIATION	Gallium Ga 68 FAPi-46	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/CT

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-09-06
• Completion: 2027-09-07
• First posted: 2025-08-12
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study