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

NCT04459273 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 20-000630NCI-2020-03766
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Carcinoma; Cervical Carcinoma; Cholangiocarcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Hepatocellular Carcinoma; Malignant Adrenal Gland Neoplasm; Malignant Brain Neoplasm; Malignant Pleural Neoplasm; Malignant Skin Neoplasm; Malignant Solid Neoplasm; Malignant Testicular Neoplasm; Malignant Thymus Neoplasm; Neuroendocrine Neoplasm; Thyroid Gland Carcinoma; Urothelial Carcinoma; Cancer of Unknown Primary Site

Outcome Measures

Primary Outcomes (1)

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

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

  At 20-90 minutes after injection]

Secondary Outcomes (2)

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

  Up to year 2

• 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution

  up to 2 years

Other Outcomes (1)

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

  60 minutes after tracer injection

Study Arms (1)

Basic science (68GA-FAPI-46 PET/CT)

EXPERIMENTAL

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).

Procedure: Computed Tomography; Drug: Gallium Ga 68 FAPi-46; Procedure: Positron Emission Tomography; Radiation: 18F-FDG

Interventions

18F-FDG RADIATION

Given IV

Also known as: 18F-fluorodeoxyglucose

Basic science (68GA-FAPI-46 PET/CT)

Gallium Ga 68 FAPi-46 DRUG

Given IV

Also known as: 68Ga-FAPi-46, Gallium-68-FAPi-46

Basic science (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 Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Basic science (68GA-FAPI-46 PET/CT)

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Basic science (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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Uterine Cervical Neoplasms; Cholangiocarcinoma; Hematologic Neoplasms; Carcinoma, Hepatocellular; Adrenal Gland Neoplasms; Brain Neoplasms; Skin Neoplasms; Testicular Neoplasms; Thymus Neoplasms; Neuroendocrine Tumors; Thyroid Neoplasms; Carcinoma, Transitional Cell; Neoplasms, Unknown Primary

Interventions

FAPI-46; Magnetic Resonance Spectroscopy; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver 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; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Testicular Diseases; Gonadal Disorders; Thoracic Neoplasms; Lymphatic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Head and Neck Neoplasms; Thyroid Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jeremie Calais

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: August 27, 2020
• Primary Completion: June 24, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2025-08

Locations

US (1)