18F-LN1 PET/CT in Urothelial Carcinomas

November 2, 2023 updated by: Hao Wang, Sichuan Provincial People's Hospital

Clinical Evaluation of 18F-LN1 PET/CT for Imaging of Nectin-4 in Urothelial Carcinomas

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Departments of Nuclear Medicine, Sichuan Provincial People's Hospital
        • Contact:

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 clinically suspected or diagnosed urothelial carcinomas

Description

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

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
Comparison of 18F-LN1 and 18F-FDG Uptake in Patients with urothelial carcinoma
Time Frame: 1 mouth
The correlation between the results of PET images and histopathological results
1 mouth

Collaborators and Investigators

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

Sponsor

Sichuan Provincial People's Hospital

Investigators

  • Study Director: Hao Wang, 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)

November 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SichuanPPH-UCs

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Urothelial Carcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe