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

NCT06084767 | Unknown

• 1 other identifier: TCR-FAPI PET/CT in cancers
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Tumor; Positron Emission Tomography; Fibroblast Activation Protein Inhibitor

Keywords

Malignant Tumor; Positron Emission Tomography; Fibroblast Activation Protein Inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tumor uptake

  90days

Study Arms (1)

Malignant tumors

EXPERIMENTAL

This arm investigated the clinical value of 68Ga-TCR-FAPI PET/CT in suspected malignant tumors.

Diagnostic Test: 68Ga-TCR-FAPI PET/CT

Interventions

68Ga-TCR-FAPI PET/CT DIAGNOSTIC_TEST

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.

Malignant tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Peking University: collaborator
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (1)

Peking University Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Shaoyan Liu, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaoyan Liu, M.D.

CONTACT

0086-010-87787190; shaoyanliu.bj@263.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 68Ga-TCR-FAPI PET/CT was used for patients with suspected malignant tumors

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: May 5, 2023
• Primary Completion: April 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)