PET/CT for Trop2 ADC Response Evaluation Cancers

NCT ID: NCT07046689

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Trop2 PET/CT

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

68Ga-MY6349 PET/CT

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liang Zhao, phd

Role: CONTACT

86 18818350620

Facility Contacts

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Liang Zhao

Role: primary

86 0592-213-7366

Other Identifiers

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XMYY-2025KY102

Identifier Type: -

Identifier Source: org_study_id

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