About this trial
To explore the efficacy of 68Ga-GZMB PET/CT in assessing the response to neoadjuvant therapy for breast cancer, and to investigate the optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response (pCR), aiming to provide a new and effective means for accurately and non-invasively evaluating the efficacy of neoadjuvant therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 16-65
histologically confirmed unilateral primary invasive breast cancer
Tumor size≥2cm, axillary lymph node positive, treated with neoadjuvant therapy
complete clinical and histo-pathological information
Disqualifiers
bilateral or metastatic (stage IV) breast cancer
There has been a history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
Severe systemic infection or other uncontrolled diseases
Patients with psychiatric disorders or those unable to comply with treatment due to other reasons
Trial population
Breast cancer patients receiving neoadjuvant treatment
Trial design
Cohort
Prospective
Treatments tested in this trial
68Ga-GZMB PET/CT
Device68Ga-GZMB PET/CT
Treatment groups
Trial outcomes
Primary outcomes
Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pCR
Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response after neoadjuvant therapy in breast cancer
Secondary outcomes
Sensitivity and specificity of 68Ga-GZMB PET/CT for pCR
Sensitivity and specificity of 68Ga-GZMB PET/CT in assessing pathological complete response after neoadjuvant therapy for breast cance
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT
Correlation between the efficacy of 68Ga-GZMB PET/CT in predicting pathological complete response and tumor-infiltrating lymphocytes
Correlation between the efficacy of 68Ga-GZMB PET/CT in predicting pathological complete response and tumor-infiltrating lymphocytes
Sponsors and contacts
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