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

Phase 1

Recruiting

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

• Registration Number: NCT04459273
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

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).

Study Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-07
• Study Start: 2020-08-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Basic science (68GA-FAPI-46 PET/CT)	Computed Tomography	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).
Basic science (68GA-FAPI-46 PET/CT)	Gallium Ga 68 FAPi-46	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).
Basic science (68GA-FAPI-46 PET/CT)	Positron Emission Tomography	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).
Basic science (68GA-FAPI-46 PET/CT)	18F-FDG	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).

Primary Outcome Measures

Name	Time	Method
Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues	At 20-90 minutes after injection]	Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).

Secondary Outcome Measures

Name	Time	Method
68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)	Up to year 2	Will be correlated with FAP expression in surgically removed or biopsy derived tumor tissue.
68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution	up to 2 years	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-)

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States