RecruitingNCT07151898
PET/CT for Trop2 ADC Response Evaluation NSCLC
Evaluation of Treatment Response to Trop2 ADC by 68Ga-MY6349 PET/CT in NSCLC
Sponsor
The First Affiliated Hospital of Xiamen University
Enrollment
50 participants
Start Date
May 1, 2025
Study Type
OBSERVATIONAL
Conditions
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 NSCLC patients.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- adult patients (aged 18 years or order)
- histologically or cytologically confirmed metastatic NSCLC previously treated with systemic therapy, supported by imaging (e.g. CT, MRI), 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
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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 and/or four cycles of Trop2-ADC therapy.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07151898
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