Using PET/CT to assess breast cancer treatment effectiveness
Clinical Study on the Evaluation of Neoadjuvant Therapy Efficacy in Breast Cancer Using PET/CT With Granzyme B Imaging Probe
This study is testing a new imaging method to see how well neoadjuvant therapy works for patients with invasive breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06725940 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 68Ga-GZMB PET/CT imaging in determining how well patients with invasive breast cancer respond to neoadjuvant therapy. It aims to identify the optimal SUVmax threshold for predicting pathological complete response (pCR) to treatment. By providing a non-invasive method to assess treatment efficacy, the study seeks to improve patient management and outcomes in breast cancer care.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16-65 with unilateral primary invasive breast cancer, tumor size ≥2cm, and positive axillary lymph nodes who are undergoing neoadjuvant therapy.
Not a fit: Patients with bilateral or metastatic breast cancer, or those with a history of other malignancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate assessments of treatment response, allowing for better-informed clinical decisions in breast cancer management.
How similar studies have performed: While the use of PET/CT in cancer assessment is established, this specific approach using Granzyme B is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai
- Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xiaosong Chen — Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
- Study coordinator: Xiaosong Chen
- Email: chenxiaosong0156@hotmail.com
- Phone: +86-21-64370045-602102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.