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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Early Phase 1

Conditions: FAP- Expressing Positive Tumors; RGD- Expressing Positive Tumors

Treatments: Drug: 68Ga-FAPI-RGD for PET / CT scan and 177Lu-FAPI-RGD for therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06638034

PUMCH-FR-TRT

Details and patient eligibility

About

FAP and RGD are overexpressed in many tumor tissues. This study is intended to conduct preliminary clinical transformation and internal irradiation dosimetry research on 177Lu-FAPI-RGD--a new dual-targeted 177Lu therapeutic drug for the first time in the world.

Full description

Fibroblast activation protein (FAP) and RGD are serine peptidase on the surface of tumor associated fibroblasts. It has special biological characteristics and stable genome. They are 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,Receptor imaging with a single target also has some limitations in clinical application. For example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion. The dual-target molecular imaging based on FAP expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors and used to 177Lu PRRT. We'll try to assess the safety and therapeutic response to 177Lu-FAPI-RGD in patients with metastatic tumors in human.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

68Ga-FAPI-RGD PET/CT for scan and 177Lu-FAPI-RGD for therapy

Experimental group

Description:

All patients diagnosed with metastatic tumors underwent 68Ga-FAPI-RGD 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 2.22-3.33 GBq (60-100 mCi) of 177Lu-FAPI-RGD for therapy.

Treatment:

Drug: 68Ga-FAPI-RGD for PET / CT scan and 177Lu-FAPI-RGD for therapy