18F-LN1 PET/CT in Urothelial Carcinomas | NCT06120413

Studies
18F-LN1 PET/CT in Urothelial Carcinomas

NCT06120413

Sponsor

Sichuan Provincial People's Hospital

Status

Unknown status

Last Update Posted

Nov 7, 2023Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Urothelial Carcinoma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

Oct 2024Estimated

First Submitted Date

Nov 2, 2023

First Submission Date that Met QC Criteria

Nov 2, 2023

First Posted Date

Nov 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2023

Last Update Posted Date

Nov 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hao Wang, Associate senior physician, Sichuan Provincial People's HospitalPrincipal Investigator

Lead Sponsor

Sichuan Provincial People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with clinically suspected or diagnosed urothelial carcinomas

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hao Wang, Doctor	Contact	+86-18313820216		474556259@qq.com

Overall Officials

Name	Affiliation	Role
Hao Wang	Sichuan Provincial People's Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departments of Nuclear Medicine, Sichuan Provincial People's Hospital	Recruiting	Chengdu	Sichuan	610072	China

Condition Browse Module

MeSH Terms

ID	Term
D002295	Carcinoma, Transitional Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

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