GzmB-PET/CT to Evaluate Neoadjuvant Therapy Efficacy in Breast Cancer

Официальное название

Clinical Study on the Evaluation of Neoadjuvant Therapy Efficacy in Breast Cancer Using PET/CT With Granzyme B Imaging Probe

Обзор

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.

Вмешательства

• Устройство 68Ga-GZMB PET/CT
  68Ga-GZMB PET/CT

Первичные конечные точки

• Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pCR [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (3)

• Sensitivity and specificity of 68Ga-GZMB PET/CT for pCR [Срок оценки: through study completion, an average of 1 year]
• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT [Срок оценки: through study completion, an average of 1 year]
• Correlation between the efficacy of 68Ga-GZMB PET/CT in predicting pathological complete response and tumor-infiltrating lymphocytes [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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
• ECOG 0-1 within 10 days from the beginning of the study
• Normal Bone Marrow Reserve: White blood cell count ≥ 3.0×10\^9/L, Neutrophil count ≥ 1.5×10\^9/L, Hemoglobin level ≥ 90g/L; Platelet count (PLT) ≥ 80×10\^9/L; Normal Liver and Kidney Function: Blood aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal, Total bilirubin ≤ 1.5 times the upper limit of normal, Serum creatinine ≤ 1.5 times the upper limit of normal, and Creatinine clearance rate > 50ml/min.
• The patient has good compliance with the planned treatment, understands the research procedures, and has signed a written informed consent form

Критерии исключения

• 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
• Known allergy or intolerance to the drug or its excipients
• Having received cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason in the past
• Patients who are pregnant or lactating, as well as patients of reproductive age who refuse to take appropriate contraceptive measures during the course of this trial.
• Patients deemed unsuitable for participation in this study by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital — Шанхай

Идентификаторы

NCT: NCT06725940 · RJBC-GZMB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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