GzmB-PET/CT to Evaluate Neoadjuvant Therapy Efficacy in B... | NCT06725940

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

NCT06725940

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Recruiting

Last Update Posted

Dec 10, 2024Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Breast Cancer Invasive

Interventions

68Ga-GZMB PET/CT

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Nov 1, 2025Estimated

Completion Date

Nov 1, 2025Estimated

First Submitted Date

Nov 24, 2024

First Submission Date that Met QC Criteria

Dec 5, 2024

First Posted Date

Dec 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2024

Last Update Posted Date

Dec 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
Study cohort		Patient receiving 68Ga-GZMB PET/CT	Device: 68Ga-GZMB PET/CT

Name	Type	Description	Arm Group Labels	Other Names
68Ga-GZMB PET/CT	Device	68Ga-GZMB PET/CT	Study cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
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	through study completion, an average of 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Breast cancer patients receiving neoadjuvant treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaosong Chen	Contact	+86-21-64370045-602102		chenxiaosong0156@hotmail.com
Siji Zhu	Contact	+86-21-64370045-602102		zsj_mu@yeah.net

Overall Officials

Name	Affiliation	Role
Xiaosong Chen	Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital	Recruiting	Shanghai		200025	China

ID	Term
D001943	Breast Neoplasms
D052497	Lipodystrophy, Congenital Generalized

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases