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

Last updated: October 10, 2024
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasm Metastasis

Neoplasms

Treatment

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

Clinical Study ID

NCT06638034
PUMCH-FR-TRT
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • pregnancy;

  • breastfeeding;

  • any medical condition that in the opinion of the investigator may significantlyinterfere with study compliance

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: 68Ga-FAPI-RGD for PET / CT scan and 177Lu-FAPI-RGD for therapy
Phase: 1
Study Start date:
May 01, 2024
Estimated Completion Date:
February 01, 2025

Study 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.

Connect with a study center

  • Chinese Academy of Medical Science & Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

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