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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
RECRUITING
Shanghai
Contact Information
Primary
Xiaosong Chen
chenxiaosong0156@hotmail.com
+86-21-64370045-602102
Backup
Siji Zhu
zsj_mu@yeah.net
+86-21-64370045-602102
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 50
Treatments
Study cohort
Patient receiving 68Ga-GZMB PET/CT
Related Therapeutic Areas
Sponsors
Leads: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov