Using PET imaging to predict treatment response in bladder cancer patients
Official title: Al18F-HER2-BCH PET/CT to Predict Response in Bladder Cancer Patients Treated With HER2 ADC
Run by Peking University Cancer Hospital & Institute · NCT06548529 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | trastuzumab |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2028 |
| Registry record updated | August 23, 2024 |
| Trial ID | NCT06548529 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with significant hepatic or renal dysfunction, those who are pregnant, or individuals with claustrophobia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results using similar PET imaging approaches to evaluate treatment responses in cancer patients.
Who can join: the full rules
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 it's running
-
uEXPLORER total-body PET/CT scanner (United Imaging, China)
Beijing, China Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
PD-L1-targeted PET probe to map PD-L1 in solid tumors
A PET tracer called 18F-F-PDL1-3 is being tested to see if it can detect PD-L1 expression in primary and metastatic tumors to help guide personalized treatment.
-
Local methylene blue injection around the pelvis to help avoid leakage after rectal cancer surgery
This study tests whether injecting a diluted methylene blue around the pelvic area after rectal cancer surgery can reduce leakage and help avoid a permanent stoma in high-risk patients.
-
18F-grazy-02 PET/CT to monitor immune therapy in cancer
This study tests whether 18F-grazy-02 PET/CT can safely monitor immune therapy in people with lymphoma or solid tumors being treated with immune checkpoint inhibitors or CAR-T cells.
-
Firmonertinib given before surgery for EGFR-mutated NSCLC
This study tests whether taking firmonertinib before and around surgery helps patients with resectable EGFR-mutated NSCLC see more tumor shrinkage before the operation.
-
CAIX-targeted PET imaging to help diagnose kidney cancer
This early-phase PET imaging study tests a CAIX-targeted tracer to see if it can help identify clear cell renal cell carcinoma in patients with kidney cancer.
-
Regorafenib plus envafolimab versus physician's choice for metastatic GIST with KIT exon 17 mutation
This study will test whether combining regorafenib with the immune drug envafolimab helps people with metastatic GIST who have KIT exon 17 mutations and have stopped responding to standard treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.