Urothelial CarcinomaNCT06120413
18F-LN1 PET/CT in Urothelial Carcinomas
An observational study of Urothelial Carcinoma, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinically suspected or diagnosed urothelial carcinomas
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Departments of Nuclear Medicine, Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Hao Wang, Doctor, +86-18313820216, 474556259@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Urothelial Carcinoma
- Medical subject headings
- Carcinoma, Transitional Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of 18F-LN1 and 18F-FDG Uptake in Patients with urothelial carcinoma
The correlation between the results of PET images and histopathological results
Measured: 1 mouth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2023
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Wang, Sichuan Provincial People's Hospital
- Investigators
- Hao Wang, Study director, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120413
- Sponsor's protocol ID
- SichuanPPH-UCs
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 18F-LN1 PET/CT for Imaging of Nectin-4 in Urothelial Carcinomas
- ClinicalTrials.gov ID
- NCT06120413
- Acronym / sponsor ID
- SichuanPPH-UCs
- Conditions
- Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically suspected or diagnosed urothelial carcinomas
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Wang study director
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Wang, Doctor (+86-18313820216, 474556259@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of 18F-LN1 and 18F-FDG Uptake in Patients with urothelial carcinoma (time frame: 1 mouth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.