68Ga-TCR-FAPI PET/CT in Patients With Various Types of Cancer

Evaluating the Clinical Value of 68Ga-TCR-FAPI PET/CT in Patients With Various Types of Cancer

Adding targeted covalent radiopharmaceutical (TCR) moiety to fibroblast activation protein inhibitor (FAPI) can increase tumor uptake and tumor retention in pre-clinical studies. This study is an open-labeled single-arm phase II diagnostic clinical trial to explore the clinical value of 68Ga-TCR-FAPI PET/CT in suspected malignant tumor patients.

Study Overview

• Status: Recruiting
• Conditions: Malignant Tumor; Positron Emission Tomography; Fibroblast Activation Protein Inhibitor
• Intervention / Treatment: Diagnostic test: 68Ga-TCR-FAPI PET/CT

Detailed Description

TCR-FAPI can covalently bind to FAP that increase tumor uptake and tumor retention in pre-clinical studies, which elevates the ability for cancer imaging and facilitates the targeted radionuclide therapy. This study is an open-labeled single-arm phase II diagnostic clinical trial to explore the clinical value of 68Ga-TCR-FAPI PET/CT in suspected malignant tumor patients. Quantitative features (i.e., SUVmax) will be calculated to evaluate the PET images. Alternative imaging modality, including but not limited to, Ultrasound, CT, MRI, and PET/CT with other radiotracers, might be applied according to clinical needs. For patients who took surgery after multiple examination, tumor tissue and histopathology will also be obtained. For patients who underwent other treatment, treatment response of each individual lesion will be observed.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shaoyan Liu, M.D.; Phone Number: 0086-010-87787190; Email: shaoyanliu.bj@263.net

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Cancer Hospital
    • Contact: Zhibo Liu, Ph.D.; Phone Number: 0086-010-62751715; Email: zbliu@pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Suspected to have malignant tumors (supported by MRI and/or CT and/or tumor markers and/or pathology report), the tumor may be newly diagnosed or previously treated;
• Meet the indications for PET examination, show a clear indication and no contraindications;
• Have a performance status of score ≥ 80 on KPS scale or score 0-1 points on ECOG scale, a relatively good general situation;
• No major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection;
• Be ≥ 18 years of age;
• Be willing and able to understand the research content and provide written informed consent/assent for the trial.

Exclusion Criteria:

• Have a history of imaging agent allergies;
• Does not meet the PET-CT scan sedation requirements, or has contraindications for PET-CT examination;
• Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Malignant tumors; This arm investigated the clinical value of 68Ga-TCR-FAPI PET/CT in suspected malignant tumors.	Diagnostic test: 68Ga-TCR-FAPI PET/CT; A dose of 3.7 MBq/kg 68Ga-TCR-FAPI will be intravenously injected and PET examination will be carried out within the specified time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	The sensitivity, specificity, and accuracy of 68Ga-TCR-FAPI PET/CT to detect tumor lesions were calculated to evaluate the diagnostic efficacy.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor uptake	The standardized uptake value (SUV) of lesions were calculated.	90days

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Peking University; Peking University Cancer Hospital & Institute
• Investigators: Principal Investigator: Shaoyan Liu, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Positron Emission Tomography; Malignant Tumor; Fibroblast Activation Protein Inhibitor
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TCR-FAPI PET/CT in cancers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No