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

Running, not enrolling · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT07118176

Run by

Jonsson Comprehensive Cancer Center

People needed

30

Starts

2025-08-01

Expected to finish

2027-09-07

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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