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18F-LN1 PET/CT in Urothelial Carcinomas

Sponsor
Sichuan Provincial People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06120413
Collaborator
(none)
30
Enrollment
1
Location
11
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The clinical feasibility of 18F-LN1 PET/CT will be evaluated in 30 patients with urothelial carcinoma, and the results will be compared with those of 18F-FDG.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study aims to evaluate the recognition efficiency of 18F-LN1 and 18F-FDG PET imaging for tumor target Nectin-4 in patients with urothelial carcinoma. The main method is to compare the results of visually interpreted PET images with histopathological results (through surgery or biopsy), which are the gold standard for final diagnosis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Evaluation of 18F-LN1 PET/CT for Imaging of Nectin-4 in Urothelial Carcinomas
    Actual Study Start Date :
    Nov 1, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2024
    Anticipated Study Completion Date :
    Oct 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of 18F-LN1 and 18F-FDG Uptake in Patients with urothelial carcinoma [1 mouth]

      The correlation between the results of PET images and histopathological 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, urothelial carcinomas and have had no other treatment within 3 months

    Exclusion Criteria:

    • Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg

    • Complicated with chronic liver disease, myocardial infarction, stroke

    • Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception

    • Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Departments of Nuclear Medicine, Sichuan Provincial People's Hospital Chengdu Sichuan China 610072

    Sponsors and Collaborators

    • Sichuan Provincial People's Hospital

    Investigators

    • Study Director: Hao Wang, Sichuan Provincial People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hao Wang, Associate senior physician, Sichuan Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT06120413
    Other Study ID Numbers:
    • SichuanPPH-UCs
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Transitional Cell

    Study Results

    No Results Posted as of Nov 7, 2023