Diagnosis of Metastatic Tumors on 68Ga-FAPI PET-CT and Radioligand Therapy With 177Lu-EB-FAPI

Early Phase 1

• Conditions: 177Lu-EB-FAPI
• Interventions: Drug: 68Ga-FAPI for PET / CT scan and 177Lu-EB-FAPI for therapy

• Registration Number: NCT05400967
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

FAP is a fibroblast activation protein and overexpressed in many tumor tissues. This study is intended to conduct preliminary clinical transformation and internal irradiation dosimetry research on 177Lu-EB-FAPI--a new 177Lu therapeutic drug modified by Evans Blue (EB) for the first time in the world.

Detailed Description

Fibroblast activation protein (FAP) is a serine peptidase on the surface of tumor associated fibroblasts. It belongs to type II transmembrane glycoprotein. It is rich and characteristic expressed in tumor associated fibroblasts. It has special biological characteristics and stable genome. FAP is expressed at a high level in mesenchymal cells during the embryonic period and is inhibited shortly after birth. It is usually not expressed or expressed at a low level in the resting tissues of normal adults, but it is highly expressed in diseases related to tissue repair and matrix reconstruction, such as wound healing, inflammatory response, fibrosis and cancer It plays an important role in metastasis and immunosuppression.Currently, 68Ga labeled FAPI (68Ga-FAPI) has been successfully applied to a variety of tumor PET/CT imaging, including lung cancer, breast cancer, and gastrointestinal tract tumors.By modifying FAPI with Evans blue (EB) to form a new EB-FAPI, endogenous albumin can be used as a reversible carrier to prolong the retention time of drugs in the blood, thus increasing the targeted aggregation and retention of 177Lu-EB-FAPI in tumor cells, and effectively killing a variety of transplanted tumors with positive FAP expression.we'll try to assess the safety and therapeutic response to 177Lu-EB-FAPI in patients with metastatic tumors in human.

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-01
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-05-27
• Last Update Submitted: 2022-05-27
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02
• Primary Completion: 2023-01-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• confirmed treated or untreated metastatic tumors patients;
• 68Ga-FAPI PET/CT and 18F-FDG PET/CT within two weeks;
• signed written consent.

Exclusion Criteria

• pregnancy;
• breastfeeding;
• any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI PET/CT for scan and 177Lu-EB- FAPI for therapy	68Ga-FAPI for PET / CT scan and 177Lu-EB-FAPI for therapy	All patients diagnosed with metastatic tumors underwent 68Ga-FAPI PET/CT scan. If the PET/CT showed high FAPI expression in tumor lesions of some patients, they would intravenously injected with the dose about 2.22GBq (60 mCi) of 177Lu-EB-FAPI for therapy.

Primary Outcome Measures

Name	Time	Method
Safety of therapy	through study completion, an average of 1 year	the safety assessed by CTCAE v4.0
Therapeutic effect	through study completion, an average of 1 year	the therapeutic response assessed by 68Ga-FAPI PET/CT to 177Lu-EB-FAPI in patients with metastatic tumors

Secondary Outcome Measures

Name	Time	Method
Diagnostic value	through study completion, an average of 1 year	Sensitivity and Specificity of 68Ga-FAPI PET/CT for metastatic tumors in comparison with 18F-FDG PET/CT

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China