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

Not Applicable

Recruiting

• Conditions: Fibroblast Activation Protein Inhibitor; Malignant Tumor; Positron Emission Tomography
• Interventions: Diagnostic Test: 68Ga-TCR-FAPI PET/CT

• Registration Number: NCT06084767
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

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 Timeline

• Study Start: 2023-05-05
• Status Verified: 2023-08
• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-16
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23
• Primary Completion: 2025-04-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Tumor uptake	90days	The standardized uptake value (SUV) of lesions were calculated.

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, China