Clinical Study of 18F -FAPI-RGD in Renal Tumor

April 14, 2025 updated by: Hao Wang, Sichuan Provincial People's Hospital

Linical Study of 18F Labeled Probe Targeting Fibroblast Activating Protein and Integrin avβ3 (FAPI-RGD) in Renal Tumors

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Departments of Nephrology, Sichuan Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosed or highly suspected Renal Tumor

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between clinical indicators and PET/CT results
Time Frame: 2 months
Correlation of Clinical immunohistochemical indexes, ultrasound, enhanced CT, MRI, laboratory examination indexes and 18F-FAPI-RGD PET/CT results
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Actual)

January 15, 2024

Study Completion (Actual)

February 20, 2024

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SichuanPPH- renal tumor

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe