PET/CT for Trop2 ADC Response Evaluation Cancers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Evidence of significantly impaired hepatic or renal function
Estimated life expectancy of less than 3 months
Trial population
Adult female patients with previously treated metastatic breast cancer (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report).
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
68Ga-MY6349 PET/CT
Diagnostic testEach participant will receive an intravenous injection of 68Ga-MY6349 and undergo PET/CT imaging at baseline and following two cycles of Trop2-ADC therapy.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: 68Ga-MY6349 PET/CT1 intervention
Trial outcomes
Primary outcomes
1
The predictive value of series 68Ga-MY6349 PET/CT in patients with breast cancer who received Trop2-ADC therapy
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.
Time frame
2024.11-2026.6Secondary outcomes
1
Correlation Between PET Parameters and Survival
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.
Time frame
2024.11-2026.12Sponsors and contacts
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Source ClinicalTrials.gov