PET/CT for Trop2 ADC Response Evaluation Cancers

Xiamen University

Status: Enrolling

Conditions: Breast Cancer; PET/CT; Trop2

Treatments: Diagnostic Test: 68Ga-MY6349 PET/CT

Study type: Observational

Funder types: Other

Identifiers

NCT07046689

XMYY-2025KY102

Details and patient eligibility

About

To evaluate whether serial 68Ga-MY6349 PET/CT imaging can serve as a noninvasive biomarker to predict the therapeutic efficacy of Trop2-targeted antibody-drug conjugate (Trop2-ADC) therapy in breast cancer patients.

Full description

Patients diagnosed with metastatic breast cancer will undergo 68Ga-MY6349 PET/CT imaging at baseline and after two cycles of Trop2-ADC therapy. Tumor uptake will be quantified using both maximum standardized uptake value (SUVmax) and mean SUV (SUVmean). Imaging changes will be correlated with treatment response to assess the utility of 68Ga-MY6349 PET/CT as a predictive biomarker.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients (aged 18 years or order)
• histologically or cytologically confirmed metastatic breast cancer previously treated with systemic therapy, supported by imaging (e.g., MRI, CT), tumor markers, or pathology reports
• presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
• willingness to undergo serial 68Ga-MY6349 PET/CT scans before and during Trop2-ADC therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Ability to provide written informed consent and, where applicable, assent in accordance with the requirements of the Clinical Research Ethics Committee

Exclusion criteria

• Evidence of significantly impaired hepatic or renal function
• Estimated life expectancy of less than 3 months

Trial design

50 participants in 1 patient group

68Ga-MY6349 PET/CT

Description:

Each participant will receive an intravenous injection of 68Ga-MY6349 and undergo PET/CT imaging at baseline and following two cycles of Trop2-ADC therapy.

Treatment:

Diagnostic Test: 68Ga-MY6349 PET/CT