Status:
RECRUITING
HER2 Expression of HER2 Affibody-based PET/CT to Predict Response in Bladder Cancer Patients Treated With ADC
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
HER2 Positive or Suspicious Positive Tumors
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value of HER2 expression in bladder cancer patients treated with HER2 ADC
Eligibility Criteria
Inclusion
- Aged # 18 years old; ECOG 0 or 1;
- Is unresectable or metastatic;
- Patients with HER2 positive or suspicious positive tumors;
- 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;
- Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions;
- Receives anti-HER2 ADC treatment
- Life expectancy \> 3 months
Exclusion
- Significant hepatic or renal dysfunction;
- Is pregnant or ready to pregnant;
- Cannot keep their states for half an hour;
- Refused to join the clinical research;
- Suffering from claustrophobia or other mental disorders;
- Any other situation that researchers considered it unsuitable to participate in the trial.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06548529
Start Date
June 1 2024
End Date
December 1 2028
Last Update
August 23 2024
Active Locations (1)
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1
uEXPLORER total-body PET/CT scanner (United Imaging, China)
Beijing, China