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NCT05976620 Clinical Trial

Clinical Study of 18F-FAPI-RGD in Breast Tumors

Breast Tumors Clinical Trial

Official title:
Clinical Study of 18F Labeled Probe Targeting Fibroblast Activation Protein Inhibitor and Integrin avβ3 (FAPI-RGD) in Breast Tumors

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05976620
Other study ID # SichuanPPH-Breast cancer
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 20, 2023
Est. completion date February 2024

Study information
Verified date October 2023
Source Sichuan Provincial People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to learn about the value of 18F-FAPI-RGD PET/CT imaging in Breast Tumors. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.

Description:

Breast cancer is the most common malignant disease in women worldwide.Early detection, accurate diagnosis and staging are the keys to effective treatment for breast cancer patients.18F-FDG PET/CT has become an important imaging method for the diagnosis and staging of breast cancer.However,FDG PET has certain limitations, including false-positive uptake for acute and chronic infections and false-negative uptake for less aggressive histological subtypes of breast cancer.In a number of studies, 68Ga-FAPI PET was positively correlated with the pathological grade and end-stage of primary breast cancer lesions, and SUVmax could predict tumor grade, final stage and lymph node metastasis. Compared with 18F-FDG,68Ga-FAPI PET/CT had higher specificity and accuracy in judging lymph node metastasis.Integrin αvβ3 is highly expressed in neovascular endothelial cells and tumor cells including breast cancer, and plays an important role in regulating tumor growth, angiogenesis, local invasion and metastasis potential.The use of integrin αvβ3 specific imaging probes derived from RGD peptides in breast cancer patients has also been reported. Several studies have confirmed that the heterodimer is superior to the corresponding monomer due to the polyvalent effect, thus improving the binding affinity and increasing the number of effective receptors.In order to simultaneously target FAP and integrin αvβ3, we synthesized the heterodimeric peptide FAPI-RGD from FAPI and RGD.FAPI-RGD is a heterodimeric peptide that targets FAP and αvβ3-integrin receptors. 68Ga-FAPI-RGDPET/CT imaging has been used in clinical imaging studies in patients with a variety of tumors.Therefore, we plan to use 18F-FAPI-RGD PET/CT imaging for the diagnosis and treatment of breast cancer, and preliminary experiments have confirmed that this examination has a good imaging effect.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date February 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 and above - No gender difference - Patients who have been diagnosed with, or are clinically highly suspected of, breast tumors and have had no other treatment within 3 months - Tumor size (T), lymph node status (N), and overall clinical stage of diagnosed patients were determined according to the American Joint Committee on Cancer criteria revised in 2010 Exclusion Criteria: - Patients with a second primary tumor - Pregnant or breastfeeding - Severe liver or kidney disease - Claustrophobia or other PET/CT scan contraindications

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Departments of Nuclear Medicine, Sichuan Provincial People's Hospital Chengdu Sichuan

Sponsors (1)
Lead Sponsor Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between clinical indicators and PET/CT results Correlation of Immunohistochemical indexes, ultrasound, X-ray, CT, MRI, tumor markers,estrogen assay and 18F-FAPI-RGD PET/CT results 2 months
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