Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Apr 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging test called \[68Ga\]N188, which helps doctors see a specific protein called nectin-4 in patients with urothelial carcinoma, particularly those with advanced or recurrent bladder cancer. The goal is to determine how well this test can detect the presence of nectin-4, which may help in diagnosing and tracking the disease.

To participate in the trial, you need to be between 18 and 75 years old and generally healthy, with normal heart function and a measurable tumor that your doctor believes needs further examination. It’s important that you can lie flat for about half an hour during the imaging process and are willing to follow the study's guidelines. Women who can become pregnant will need to take a pregnancy test before starting the trial, and both men and women must agree to use effective birth control during the study. If you decide to take part, you will receive clear information about the trial, and your participation will be fully voluntary.

Gender

ALL

Eligibility 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.