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

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

Interventions

PROCEDURE

Computed Tomography

Undergo PET/CT

DRUG

Gallium Ga 68 FAPi-46

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

RADIATION

18F-FDG

Given IV

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Jeremie Calais · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-27

Primary Completion

2025-06-24

Completion

2027-07-01

FDA Drug

Yes

Countries

• United States

Study Locations