GzmB-PET/CT to Evaluate Neoadjuvant Therapy Efficacy in Breast Cancer
NCT ID: NCT06725940
Last Updated: 2024-12-10
Study Results
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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RECRUITING
50 participants
OBSERVATIONAL
2024-11-01
2025-11-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study cohort
Patient receiving 68Ga-GZMB PET/CT
68Ga-GZMB PET/CT
68Ga-GZMB PET/CT
Interventions
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68Ga-GZMB PET/CT
68Ga-GZMB PET/CT
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Kunwei Shen
Professor
Principal Investigators
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Xiaosong Chen
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
Locations
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Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Xiaosong Chen
Role: primary
Siji Zhu
Role: backup
Other Identifiers
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RJBC-GZMB
Identifier Type: -
Identifier Source: org_study_id