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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorShanghai Jiao Tong University School of Medicine

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Breast cancer patients receiving neoadjuvant treatment

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 68Ga-GZMB PET/CT

    Device

    68Ga-GZMB PET/CT

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Study cohort1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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