Determining The Biodistribution Of An Imaging Tracer (68Ga-FAPi-46) In Patients With Solid Tumors Or Hematologic Cancers

Study Overview

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

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.

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.

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

PROCEDURE: Computed Tomography
OTHER: Fludeoxyglucose F-18
RADIATION: Gallium Ga 68 FAPi-46
PROCEDURE: Positron Emission Tomography

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

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-08-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-05
First Submitted that Met QC Criteria 2025-08-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-12
First Posted (ACTUAL) 2025-08-12	Results First Posted N/A	Last Verified 2025-08

Study Plan

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

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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: Fludeoxyglucose F-18 Given IV RADIATION: Gallium Ga 68 FAPi-46 Given IV PROCEDURE: Positron Emission Tomography Undergo PET/CT

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: Fludeoxyglucose F-18

Given IV

RADIATION: Gallium Ga 68 FAPi-46

Given IV

PROCEDURE: Positron Emission Tomography

Undergo PET/CT

Primary Outcome Measures	Measure Description	Time Frame
Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46)	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	Measure Description	Time Frame
Fludeoxyglucose F-18 (18F-FDG) biodistribution	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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

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

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Jeremie Calais, UCLA / Jonsson Comprehensive Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record