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Trial Title:
Diagnosis of Metastatic Tumors on 68Ga-FAPI-RGD PET-CT and Radioligand Therapy With 177Lu-FAPI-RGD
NCT ID:
NCT06638034
Condition:
FAP- Expressing Positive Tumors
RGD- Expressing Positive Tumors
Conditions: Official terms:
Neoplasms
Neoplasm Metastasis
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-FAPI-RGD for PET / CT scan and 177Lu-FAPI-RGD for therapy
Description:
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.
Arm group label:
68Ga-FAPI-RGD PET/CT for scan and 177Lu-FAPI-RGD for therapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese Academy of Medical Science & Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaohui Zhu, MD
Phone:
+8613051615100
Email:
jialinx29@126.com
Start date:
May 1, 2024
Completion date:
February 1, 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06638034
