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

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.

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

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Jeremie Calais · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-01

Primary Completion

2026-09-06

Completion

2027-09-07

FDA Device

Yes

Countries

• United States

Study Locations