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Active, Not Recruiting

NCT Number: NCT04459273

Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers

This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bladder Carcinoma Adenocarcinoma Adrenal Gland Diseases Adrenal Gland Neoplasms Brain Diseases Brain Neoplasms Cancer of Unknown Primary Site Carcinoma Carcinoma, Hepatocellular Carcinoma, Transitional Cell Central Nervous System Diseases Central Nervous System Neoplasms Cervical Carcinoma Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Hematologic Diseases Hematologic Neoplasms Hematopoietic and Lymphoid Cell Neoplasm Hemic and Lymphatic Diseases Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Lymphatic Diseases Male Urogenital Diseases Malignant Adrenal Gland Neoplasm Malignant Brain Neoplasm Malignant Pleural Neoplasm Malignant Skin Neoplasm Malignant Solid Neoplasm Malignant Testicular Neoplasm Malignant Thymus Neoplasm Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Unknown Primary Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Neoplasm Neuroendocrine Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Testicular Diseases Testicular Neoplasms Thoracic Neoplasms Thymus Neoplasms Thyroid Diseases Thyroid Gland 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

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 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies.

SECONDARY OBJECTIVES:

I. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue.

II. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-)

EXPERIMENTAL OBJECTIVE:

To assess the correlation of 68Ga-FAPI-46 biodistribution with 68Ga-DOTATATE or 18F-DOPA (FDOPA), depending on the specific indication in patients who had them available

OUTLINE:

Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with the following cancer types:
  • Brain cancer
  • Bladder cancer
  • Urothelial cancer
  • Testicular cancer
  • Skin cancer
  • Thyroid cancer
  • Hepatocellular carcinoma
  • Cholangiocarcinoma
  • Thymus cancer
  • Pleural cancer
  • Cervical cancer
  • Adrenal cancer
  • Neuroendocrine tumors
  • Hematologic cancer
  • Cancer of Unkown Primary
  • Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis
  • 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
  • Patients with any new cancer therapy between the baseline PET/CT and the investigational FAPI PET/CT
  • 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, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Gallium Ga 68 FAPi-46

Drug

Given IV

Other names: 68Ga-FAPi-46, Gallium-68-FAPi-46

Positron Emission Tomography

Procedure

Undergo PET/CT

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

18F-FDG

Radiation

Given IV

Other names: 18F-fluorodeoxyglucose

Primary outcomes

  1. Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues

    Time frame: At 20-90 minutes after injection]

    Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).

Secondary outcomes

  1. 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)

    Time frame: Up to year 2

    Will be correlated with FAP expression in surgically removed or biopsy derived tumor tissue.

  2. 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution

    Time frame: up to 2 years

    • To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-)

Other outcomes

  1. To assess the 68Ga-FAPI-46 biodistribution correlation with other PET tracers

    Time frame: 60 minutes after tracer injection

    The other PET tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax). The SUV of FAPI PET and the other PET tracers will be tested for correlation.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study title

PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation

Acronym: FAPI PET RDRC

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Jul 7, 2020
Registry last updated
Feb 5, 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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