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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05976607
Other study ID # SichuanPPH- renal tumor
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 Renal Tumor. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.


Description:

Early detection, accurate diagnosis and staging are the keys to effective treatment of kidney cancer patients.Pathological diagnosis is still the gold standard, but renal perforation is invasive examination, there are certain complications, the most common is bleeding and hematoma, rare renal arteriovenous fistula formation and infection.A non-invasive test with high accuracy is expected.68Ga-FAPI-04 has been reported to be superior to 18F-FDG in the study of bone metastases in RCC patients, and in addition to detecting more metastases than 18F-FDGPET/CT, uptake is 3-4 times higher than 18F-FDG.There are also many literatures reporting that APIPET/CT may be better than 18F-FDGPET/CT in the detection of various malignant tumors, and FAPI targeted imaging is a promising way in the diagnosis and treatment of papillary renal cell carcinoma. 18F-FPPRGD2PET/CT may be a useful tool for monitoring early response to anti-angiogenic therapy in patients with mRCC.18F-FPRGD2PET/CT reliably estimated the expression of integrin αvβ3 in renal tumors, and in clear cell RCC(ccRCC) groups, 18F-FPRGD2PET signal correlated with the expression of integrin αvβ3 in tumor cells.In the papillary RCC(pRCC) group, the signal was correlated with the expression of αvβ3.The expression of integrin αvβ3 in ccRCC cells was significantly higher than that in pRCC cells.These findings are consistent with results obtained with other RGD-based tracers in various cancers.The expression level of integrin αvβ3 in tumor cells is associated with invasiveness and metastasis potential, and quantifying it with PET may contribute to the study of integrin αvβ3 as a prognostic factor. Heterodimer peptide FAPI-RGD was synthesized 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 of patients with various tumors.So, we plan to use 18F-FAPI-RGD PET/CT imaging is used in the diagnosis and treatment of renal 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, renal tumors and have had no other treatment within 3 months 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 Nephrology, 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 Clinical immunohistochemical indexes, ultrasound, enhanced CT, MRI, laboratory examination indexes and 18F-FAPI-RGD PET/CT results 2 months
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