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

NCT07118176 | Recruiting Phase 1 DMC FDA Device

• 2 other identifiers: 25-0201NCI-2025-04961
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fludeoxyglucose F-18 (18F-FDG) biodistribution

  Up to 2 years

Study Arms (1)

Diagnostic (68Ga-FAPi-46 PET/CT)

EXPERIMENTAL

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; Other: Fludeoxyglucose F-18; Radiation: Gallium Ga 68 FAPi-46; Procedure: Positron Emission Tomography

Interventions

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Diagnostic (68Ga-FAPi-46 PET/CT)

Fludeoxyglucose F-18 OTHER

Given IV

Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Diagnostic (68Ga-FAPi-46 PET/CT)

Gallium Ga 68 FAPi-46 RADIATION

Given IV

Also known as: (68GA)Ga-FAPI-46, 68Ga-FAPi-46, FAPI-46 GA-68, Gallium-68-FAPI-46

Diagnostic (68Ga-FAPi-46 PET/CT)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Diagnostic (68Ga-FAPi-46 PET/CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Anus Neoplasms; Urinary Bladder Neoplasms; Breast Neoplasms; Uterine Cervical Neoplasms; Cholangiocarcinoma; Colorectal Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Carcinoma, Hepatocellular; Lung Neoplasms; Adrenal Gland Neoplasms; Brain Neoplasms; Testicular Neoplasms; Uterine Neoplasms; Neuroendocrine Tumors; Ovarian Neoplasms; Pancreatic Neoplasms; Penile Neoplasms; Prostatic Neoplasms; Salivary Gland Neoplasms; Sarcoma; Solitary Fibrous Tumors; Thyroid Neoplasms; Carcinoma, Medullary; Carcinoma, Transitional Cell; Vaginal Neoplasms

Interventions

Fluorodeoxyglucose F18; FAPI-46; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Colonic Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Diseases; Liver Neoplasms; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Testicular Diseases; Gonadal Disorders; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Ovarian Diseases; Adnexal Diseases; Pancreatic Diseases; Penile Diseases; Prostatic Diseases; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Thyroid Diseases; Carcinoma, Neuroendocrine; Neoplasms, Ductal, Lobular, and Medullary; Vaginal Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jeremie Calais

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): September 7, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

US (1)