PET/CT for Trop2 ADC Response Evaluation Cancers

Recruiting

• Conditions: Breast Cancer; Trop2; PET/CT

• Registration Number: NCT07046689
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

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.

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• (i) Evidence of significantly impaired hepatic or renal function; (ii) Estimated life expectancy of less than 3 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China