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

NCT ID: NCT06638034

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-02-01

Brief Summary

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.

Detailed 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.

Conditions

FAP- Expressing Positive Tumors; RGD- Expressing Positive Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Patients with positive results were screened with 68Ga-FAPI PET / CT, and 2.22-3.33GBq(60mci-100mCi) 177Lu-FAPI-RGD was injected intravenously for therapy after contraindications were excluded and informed consent was signed.

Interventions

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

Patients with positive results were screened with 68Ga-FAPI PET / CT, and 2.22-3.33GBq(60mci-100mCi) 177Lu-FAPI-RGD was injected intravenously for therapy after contraindications were excluded and informed consent was signed.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhaohui Zhu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chinese Academy of Medical Science & Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhaohui Zhu, MD

Role: CONTACT

13611093752@163.com

13611093752

Facility Contacts

Zhaohui Zhu, MD

Role: primary

jialinx29@126.com

+8613051615100

Other Identifiers

PUMCH-FR-TRT

Identifier Type: -

Identifier Source: org_study_id