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NCT Number: NCT07118176

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.

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Key information

Conditions

Anal Carcinoma Adenocarcinoma Adnexal Diseases Adrenal Gland Diseases Adrenal Gland Neoplasms Anus Diseases Anus Neoplasms Bladder Carcinoma Brain Diseases Brain Neoplasms Breast Carcinoma Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Hepatocellular Carcinoma, Medullary Carcinoma, Neuroendocrine Carcinoma, Transitional Cell Central Nervous System Diseases Central Nervous System Neoplasms Cervical Carcinoma Cholangiocarcinoma Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Carcinoma Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Carcinoma Head and Neck Neoplasms Hematopoietic and Lymphatic System Neoplasm Hepatocellular Carcinoma Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Lung Carcinoma Lung Diseases Lung Neoplasms Male Urogenital Diseases Malignant Adrenal Gland Neoplasm Malignant Brain Neoplasm Malignant Neoplasm of Unknown Primary Malignant Solid Neoplasm Malignant Testicular Neoplasm Malignant Uterine Neoplasm Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Fibrous Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Neoplasm Neuroendocrine Tumors Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Pancreatic Carcinoma Pancreatic Diseases Pancreatic Neoplasms Penile Carcinoma Penile Diseases Penile Neoplasms Pleural Carcinomatosis Primary Peritoneal Carcinoma Prostate Carcinoma Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Salivary Gland Carcinoma Salivary Gland Diseases Salivary Gland Neoplasms Sarcoma Skin Carcinoma Skin Diseases Skin and Connective Tissue Diseases Solitary Fibrous Tumor Solitary Fibrous Tumors Stomach Diseases Stomach Neoplasms Stomatognathic Diseases Testicular Diseases Testicular Neoplasms Thoracic Neoplasms Thymus Carcinoma Thyroid Diseases Thyroid Gland Carcinoma Thyroid Gland Medullary Carcinoma Thyroid Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Carcinoma Vaginal Diseases Vaginal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Computed Tomography

Procedure

Undergo PET/CT

Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Fludeoxyglucose F-18

Other

Given IV

Other names: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Gallium Ga 68 FAPi-46

Radiation

Given IV

Other names: (68GA)Ga-FAPI-46, 68Ga-FAPi-46, FAPI-46 GA-68, Gallium-68-FAPI-46

Positron Emission Tomography

Procedure

Undergo PET/CT

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Primary outcomes

  1. Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46)

    Time frame: Up to 2 years

    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.

Secondary outcomes

  1. Fludeoxyglucose F-18 (18F-FDG) biodistribution

    Time frame: Up to 2 years

    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-.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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