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

Peking University Cancer Hospital & Institute

Status: Enrolling

Conditions: HER2 Positive or Suspicious Positive Tumors

Treatments: Radiation: HER2 expression of PET imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT06548529

2019KT114

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Al18F-HER2-BCH PET/CT in bladder cancer patients

Experimental group

Treatment:

Radiation: HER2 expression of PET imaging