uEXPLORER total-body PET/CT scanner (United Imaging, China)
Beijing, China
Location status: Recruiting
Recruiting
NCT Number: NCT06548529
HER2 Expression of HER2 Affibody-based PET/CT to Predict Response in Bladder Cancer Patients Treated With ADC
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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.
Treatment and study plan
HER2 expression of PET imaging
RadiationEvaluate the diagnostic potential of HER2 imaging using 18F-labelled HER2 affibody , evaluate the predictive and prognostic value of HER2 PET imaging in bladder cancer patients treated with ADC
Primary outcomes
-
SUV
Time frame: 4 years
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT
Sponsors and collaborators
Lead sponsor
Peking University Cancer Hospital & Institute
Other
Registry information
Official study title
Al18F-HER2-BCH PET/CT to Predict Response in Bladder Cancer Patients Treated With HER2 ADC
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Aug 12, 2024
- Registry last updated
- Aug 23, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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