RecruitingNCT07046689

PET/CT for Trop2 ADC Response Evaluation Cancers

Evaluation of Treatment Response to Trop2 ADC by 68Ga-MY6349 PET/CT in Advanced Breast Cancer

Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

50 participants

Start Date

Nov 1, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Trop2 PET/CT

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

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 Criteria2

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

Interventions

DIAGNOSTIC_TEST68Ga-MY6349 PET/CT

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.