HER2 Positive or Suspicious Positive Tumors
Conditions
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
Interventions
RADIATIONHER2 expression of PET imaging
Evaluate 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
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SUV | 4 years | The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT |
Countries
China
Outcome results
None listed