Using PET imaging to predict treatment response in bladder cancer patients
Al18F-HER2-BCH PET/CT to Predict Response in Bladder Cancer Patients Treated With HER2 ADC
This study is testing if a special imaging technique can help predict how well bladder cancer patients with certain tumors will respond to a new treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | trastuzumab |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06548529 on ClinicalTrials.gov |
What this trial studies
This study evaluates the predictive and prognostic value of HER2 expression in bladder cancer patients using a molecular PET radionuclide labeled HER2 Affibody. Patients with HER2 positive or suspicious positive tumors who have previously been treated with trastuzumab and taxane will undergo PET imaging to assess their response to anti-HER2 antibody-drug conjugate (ADC) treatment. The study aims to determine how well HER2 expression can predict treatment outcomes in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unresectable or metastatic HER2 positive or suspicious positive bladder tumors who have received prior treatment with trastuzumab and taxane.
Not a fit: Patients with significant hepatic or renal dysfunction, those who are pregnant, or individuals with claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for bladder cancer patients based on HER2 expression levels.
How similar studies have performed: Other studies have shown promising results using similar PET imaging approaches to evaluate treatment responses in cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged # 18 years old; ECOG 0 or 1; 2. Is unresectable or metastatic; 3. Patients with HER2 positive or suspicious positive tumors; 4. was previously treated with trastuzumab and taxane in the advanced setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane; 5. Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions; 6. Receives anti-HER2 ADC treatment 7. Life expectancy \> 3 months Exclusion Criteria: 1. Significant hepatic or renal dysfunction; 2. Is pregnant or ready to pregnant; 3. Cannot keep their states for half an hour; 4. Refused to join the clinical research; 5. Suffering from claustrophobia or other mental disorders; 6. Any other situation that researchers considered it unsuitable to participate in the trial.
Where this trial is running
Beijing
- uEXPLORER total-body PET/CT scanner (United Imaging, China) — Beijing, China (Recruiting)
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.