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

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

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.

Study Overview

• Status: Recruiting
• Conditions: FAP- Expressing Positive Tumors; RGD- Expressing Positive Tumors
• Intervention / Treatment: Drug: 68Ga-FAPI-RGD for PET / CT scan and 177Lu-FAPI-RGD for therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Zhaohui Zhu, MD; Phone Number: 13611093752; Email: 13611093752@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Chinese Academy of Medical Science & Peking Union Medical College Hospital
      • Contact: Zhaohui Zhu, MD; Phone Number: +8613051615100; Email: jialinx29@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tandarStandardized uptake value of 177Lu-TATE-RGD in normal organs and tumors.	The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value at each time point in normal organs and tumors will be measured.	through study completion, an average of half-year
Adverse events collection	Adverse events within 2 months after the injection and scanning of patients will be followed and assessed.	through study completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SUVmax, SUVmean, lesion-based analysis	Sensitivity and Specificity of 68Ga-FAPI PET/CT for metastatic tumors in comparison with 18F-FDG PET/CT, including some semi-quantative quota for lesion-based analysis, such as SUVmax, SUVmean	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: PUMCH-FR-TRT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No