Imaging Nectin-4 in Bladder Cancer
Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma
This study is testing a new imaging method to see if it can help find a specific protein in patients with advanced bladder cancer to improve diagnosis and treatment planning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05321316 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a specific PET probe, [68Ga]N188, in detecting nectin-4 overexpression in patients with urothelial carcinoma, particularly those with recurrent or advanced bladder cancer. The approach involves using this imaging technique to improve diagnostic accuracy and treatment planning. Participants will undergo PET/CT examinations to assess the presence of measurable target lesions as per RECIST1.1 criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with urothelial carcinoma who are recommended for PET/CT examination.
Not a fit: Patients with serious liver, kidney, or blood abnormalities, or those who are pregnant or lactating, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the detection and management of urothelial carcinoma, leading to better treatment outcomes for patients.
How similar studies have performed: While this specific approach is novel, similar imaging techniques have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-75 years old, male or female; 2. Heart function is normal; 3. Normal heart function; 4. Estimated survival ≥12 weeks; 5. Good follow-up compliance; 6. presence of at least one measurable target lesion according to RECIST1.1 criteria; 7. Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test; 8. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging; 9. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent. Exclusion Criteria: 1. Serious abnormality of liver, kidney and blood; 2. Pregnant patients; 3. Pregnant and lactation women; 3\) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhi Yang, Professor
- Email: pekyz@163.com
- Phone: 010-88196495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.