PET/CT for Trop2 ADC Response Evaluation Cancers

NCT07046689 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital of Xiamen University

Phase

Observational

Started

2024-11-01

Last updated

2025-07-15

Condition(s) studied

Breast CancerTrop2PET/CT

Investigational drug(s) / intervention(s)

68Ga-MY6349 PET/CT

68Ga-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.

Study 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

FEMALE

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07046689 on ClinicalTrials.gov ↗ ← All trials in China