NCT06120413

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

November 2, 2023

Last Update Submit

November 2, 2023

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Comparison of 18F-LN1 and 18F-FDG Uptake in Patients with urothelial carcinoma

    The correlation between the results of PET images and histopathological results

    1 mouth

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with clinically suspected or diagnosed urothelial carcinomas

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departments of Nuclear Medicine, Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Hao Wang

    Sichuan Provincial People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Hao Wang, Doctor

CONTACT

+86-18313820216474556259@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate senior physician

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 7, 2023

Study Start

November 1, 2023

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

CN(1)