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

Malignant Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084767
• Other study ID #: TCR-FAPI PET/CT in cancers
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: August 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Shaoyan Liu, M.D.
• Phone: 0086-010-87787190
• Email: shaoyanliu.bj[@]263.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Tumor
• Neoplasms
• Positron Emission Tomography

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Peking University, Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tumor uptake	The standardized uptake value (SUV) of lesions were calculated.	90days