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

Hepatocellular Carcinoma Clinical Trial

— FAPI PET RDRC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04459273
• Other study ID #: 20-000630
• Secondary ID: NCI-2020-03766
• Status: Recruiting
• Phase: Phase 1
• Start date: August 27, 2020
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2023
• Source: Jonsson Comprehensive Cancer Center
• Contact: Ethan Lam
• Phone: 310-206-7372
• Email: eclam[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Bladder Carcinoma
• Brain Neoplasms
• Cancer of Unknown Primary Site
• 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
• Neoplasms
• Neoplasms, Unknown Primary
• Neuroendocrine Neoplasm
• Neuroendocrine Tumors
• Pleural Neoplasms
• Skin Neoplasms
• Testicular Neoplasms
• Thymus Neoplasms
• Thyroid Gland Carcinoma
• Thyroid Neoplasms
• Urinary Bladder Neoplasms
• Urothelial Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess the 68Ga-FAPI-46 biodistribution correlation with other PET tracers	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.	60 minutes after tracer injection
Primary	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	68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)	Will be correlated with FAP expression in surgically removed or biopsy derived tumor tissue.	Up to year 2
Secondary	68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution	2. 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-)	up to 2 years