Breast-Specific Gamma Imaging and Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy (BSGILAB)

April 9, 2019 updated by: Zhigang Zhang, Zhejiang University

A Prospective Study to Evaluate Dynamic Breast-Specific Gamma Imaging in Monitoring Tumor Responses in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy

A prospective cohort study design will be conducted. Patients with LABC who receive chemotherapy will undergo physical examination, ultrasound, MRI, and BSGI at baseline, midway, and at the completion of chemotherapy. Approximately 100 patients will be recruited over a 2-year period. This study will give clinicians further insight into the usefulness of ultrasound, MRI, and BSGI in monitoring treatment responses in patients with LABC. This could potentially lead to changes in clinical management of these patients.

Study Overview

Status

Unknown

Conditions

Detailed Description

Locally advanced breast cancer (LABC) is usually treated with neoadjuvant chemotherapy followed by surgery. At present, monitoring of tumor responses to chemotherapy is primarily carried out using physical examination at the beginning of each chemotherapy cycle. Differentiating viable tumor tissue from inflammation or fibrotic scar tissue can be difficult. There is a growing body of evidence that newer imaging techniques such as positron emission tomography (PET) and magnetic resonance imaging (MRI) may be better at determining whether or not the tumor is actually shrinking, but their sensitivity and specificity were not ideal. Breast-specific gamma imaging (BSGI) using 99mTcsestamibi is a relatively new nuclear medicine imaging technique for breast tumor detection. BSGI shows higher sensitivity than conventional scintimammography in the detection of small breast cancer lesions owing to its high resolution. BSGI is a useful complementary tool to ultrasound, mammography and MRI in breast cancer diagnosis, especially in dense breasts and multifocal or multicentric disease; however, little is known about the ability of BSGI to predict of clinical and pathological response to neo-adjuvant chemotherapy in patients with locally advanced breast cancer. The purpose of this study is to determine the sensitivity and specificity of BSGI in evaluating tumor responses to chemotherapy in patients with LABC and compare this with physical examination, ultrasound, mammography and MRI, which is the current conventional standard of care. A prospective cohort study design will be conducted. Patients with LABC who receive chemotherapy will undergo physical examination, ultrasound, MRI, and BSGI at baseline, midway, and at the completion of chemotherapy. Approximately 100 patients will be recruited over a 2-year period. This study will give clinicians further insight into the usefulness of ultrasound, MRI, and BSGI in monitoring treatment responses in patients with LABC. This could potentially lead to changes in clinical management of these patients.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy

Description

Inclusion Criteria

  • 18 Years and older, and histologic proof of breast cancer (invasive ductal or lobular carcinoma-not breast sarcoma or lymphoma)
  • Patients having a clinical diagnosis of locally advanced breast cancer (T3 or T4, or N2 according to TNM classification) including inflammatory breast cancer.
  • Patients must be able to undergo neoadjuvant chemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 sufficient to undergo chemotherapy

Exclusion Criteria

  • Previously treated cancer other than non melanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater.
  • Evidence of metastatic disease (found on chest X-ray, liver ultrasound or bone scan).
  • Previous chemotherapy or hormonal therapy for breast cancer.
  • Active infection or other significant illnesses which could hamper their ability to tolerate chemotherapy
  • Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease) making the patient unfit for surgery.
  • Any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment.
  • Pregnant or lactating females.
  • Inadequate hematologic, renal and liver function as measured by CBC (WBC<4.0 x 109, Hb<100 g/L, plt count<100 x 109), and abnormal hepatic transaminases (AST, ALT, GGT, alkaline phosphatase>2x normal), elevated total bilirubin, and elevated serum creatinine (Cr>110 micromol/L).
  • Any contraindication to undergoing MRI or BSGI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity/Specificity
Time Frame: 2 YEARS
BSGI have a high sensitivity/specificity t in predicting which LABC patients achieve a complete pathologic response (pCR) following neo-adjuvant chemotherapy
2 YEARS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathologic complete response
Time Frame: 2 YEARS
BSCGI might changes in clinical management by identifying non-responders earlier than with other examinations.
2 YEARS
Overall Survival
Time Frame: 2 YEARS
BSGI predict long-term survival
2 YEARS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Investigators

  • Study Chair: Jian Huang, Dr, Second Affiliated Hospital of Zhejiang University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 19, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

April 11, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSGILAB001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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