NCT04459273

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

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

Type	Name	Description
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

Timeline

• Start date: 2020-08-27
• Primary completion: 2025-06-24
• Completion: 2027-07-01
• First posted: 2020-07-07
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study