HER2 Expression of HER2 Affibody-based PET/CT to Predict Response in Bladder Cancer Patients Treated With ADC

Not Applicable

Recruiting

• Conditions: HER2 Positive or Suspicious Positive Tumors
• Interventions: Radiation: HER2 expression of PET imaging

• Registration Number: NCT06548529
• Lead Sponsor: Peking University Cancer Hospital & Institute

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-01
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-07
• Study First Posted: 2024-08-12
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2027-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Al18F-HER2-BCH PET/CT in bladder cancer patients	HER2 expression of PET imaging	-

Primary Outcome Measures

Name	Time	Method
SUV	4 years	The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT

Trial Locations

Locations (1)

uEXPLORER total-body PET/CT scanner (United Imaging, China); 🇨🇳 Beijing, China