GzmB-PET/CT to Evaluate Neoadjuvant Therapy Efficacy in Breast Cancer
Recruiting · NCT06725940 · Observational (researchers observe without assigning treatment) · Lead sponsor: Shanghai Jiao Tong University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
68Ga-GZMB PET/CT
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital - Shanghai, China