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RecruitingNCT06725940GzmB-PET4BCUpdated Dec 10, 2024

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

An observational study in Breast Cancer Invasive, sponsored by Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by Shanghai Jiao Tong University School of Medicine · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Cancer Invasive

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Keywords

  • breast cancer
  • Granzyme B
  • PET/CT
  • neoadjuvant treatment
  • pCR
03

In context

Breast Neoplasms

12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 50 is below the median of 184 across 2,643 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Breast cancer patients receiving neoadjuvant 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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Study cohort

    Patient receiving 68Ga-GZMB PET/CT

    Device: 68Ga-GZMB PET/CT

Interventions

  • Device68Ga-GZMB PET/CT

    68Ga-GZMB PET/CT

06

What researchers measure

Primary outcomes

  1. Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pCR

    Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response after neoadjuvant therapy in breast cancer

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Sensitivity and specificity of 68Ga-GZMB PET/CT for pCR

    Sensitivity and specificity of 68Ga-GZMB PET/CT in assessing pathological complete response after neoadjuvant therapy for breast cance

    Time frame: through study completion, an average of 1 year

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT

    Time frame: through study completion, an average of 1 year

  3. Correlation between the efficacy of 68Ga-GZMB PET/CT in predicting pathological complete response and tumor-infiltrating lymphocytes

    Correlation between the efficacy of 68Ga-GZMB PET/CT in predicting pathological complete response and tumor-infiltrating lymphocytes

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
    Shanghai, 200025, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06725940
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Kunwei Shen (Professor, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Dec 10, 2024
Start date
Nov 1, 2024
Primary completion
Nov 1, 2025 (estimated)
Completion
Nov 1, 2025 (estimated)
Last update
Dec 10, 2024

Study contacts

Xiaosong Chen
Contact
chenxiaosong0156@hotmail.com
+86-21-64370045-602102
Siji Zhu
Contact
zsj_mu@yeah.net
+86-21-64370045-602102
Xiaosong Chen
principal investigator · Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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