Breast Cancer, PET/CT, Trop2
Conditions
Keywords
Breast cancer, Trop2, PET/CT, Trop2-ADC
Brief 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.
Detailed 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.
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.
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The predictive value of series 68Ga-MY6349 PET/CT in patients with breast cancer who received Trop2-ADC therapy | 2024.11-2026.6 | For 68Ga-MY6349 PET/CT parameter, the maximum standard uptake value (SUVmax) is measured by defining a region of interest (ROI) around the primary tumor. SUVmax values obtained at baseline and after two cycles of Trop2-ADC therapy were collected and analyzed in relation to treatment response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between PET Parameters and Survival | 2024.11-2026.12 | Progression-free survival (PFS) amd overall survival (OS) will be monitored and analyzed in relation to imaging parameters obtained from serial 68Ga-MY6349 PET/CT scans. |
Countries
China
Contacts
Primary ContactLiang Zhao, phd
Outcome results
None listed