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

Sponsor
Sichuan Provincial People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05976607
Collaborator
(none)
30
Enrollment
6.9
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Linical Study of 18F Labeled Probe Targeting Fibroblast Activating Protein and Integrin avβ3 (FAPI-RGD) in Renal Tumors
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Jan 31, 2024
    Anticipated Study Completion Date :
    Feb 28, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between clinical indicators and PET/CT results [2 months]

      Correlation of Clinical immunohistochemical indexes, ultrasound, enhanced CT, MRI, laboratory examination indexes and 18F-FAPI-RGD PET/CT results

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sichuan Provincial People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hao Wang, Principal Investigator, Sichuan Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05976607
    Other Study ID Numbers:
    • SichuanPPH- renal tumor
    First Posted:
    Aug 4, 2023
    Last Update Posted:
    Aug 4, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Kidney Neoplasms

    Study Results

    No Results Posted as of Aug 4, 2023