Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer (DOT)

The aim of the study is to determine if DOT can detect response early in breast cancer patients undergoing neoadjuvant chemotherapy.

Study Overview

• Status: Terminated
• Conditions: Breast Neoplasms

Detailed Description

The pilot study will enrol up to ten patients over one year. Patients receiving neoadjuvant chemotherapy for breast cancer will undergo baseline clinical examination, mammography, ultrasound, MRI and DOT before commencement of treatment. DOT will be repeated at 1,3,6 weeks after chemotherapy, and at the end of each chemotherapy regimen. Ultrasound will be repeated every 6 weeks and at the end of treatment. Mammography and MRI will be repeated once at the end of treatment before surgery. A breast pathologist will evaluate the subtype of breast cancer and the pathologic response of the operative specimen at the end of treatment. Patient satisfaction questionnaires will be administered to evaluate their preferences for DOT, ultrasound, mammography and MRI scanning at the beginning and the end of the study.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169610
    • National Cancer Centre Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Approximately 60 patients are prescribed neaodjuvant chemotherapy for breast cancer at National Cancer Centre Singapore annually. Accrual is expected to be 10 patients per year. Up to 10 patients will be recruited for this study.

Description

Inclusion Criteria:

• Patients receiving neoadjuvant chemotherapy for breast cancer.
• Patients with locally advanced breast tumours or large operable tumours who require neoadjuvant treatment for downstaging.
• Histological confirmation of invasive breast carcinoma.
• Patients with metastatic disease may be eligible if they have oligometastatic disease and breast surgery after neoadjuvant chemotherapy is planned.
• Signed informed consent
• Age equal to or more than 21 years
• Life expectancy greater than 12 weeks.
• ECOG performance status 0-2

Exclusion Criteria:

• Fungating or ulcerated tumours
• Inability to provide informed consent
• Anticipated inability to follow-up patient for response to chemotherapy
• Any contraindication to undergoing ultrasound, MRI, MMG or DOT

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parameters derived from the optical images acquired with the DOT system	The primary parameters derived from the optical images acquired with the DOT system include: The volume of tumor microvasculature V, the total haemoglobin concentration (THC), and the blood volume index BVI (=VC). Other available optical parameters are: blood oxygenation in the tumor microvasculature (SO2), its spatial distribution and dynamic fluctuation; dynamic blood perfusion. These parameters will be compared with histopathological response.	These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation	The change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation will be correlated with response based on clinical examination, ultrasound, MMG and MRI. Standard definitions for clinical response will be used to classify patients into four categories: complete response (CR), partial response (PR), progressive disease (PD) and stable disease (SD).	These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months

Collaborators and Investigators

• Sponsor: National Cancer Centre, Singapore
• Collaborators: National University of Singapore
• Investigators: Principal Investigator: Yoon Sim Yap, MBBS, FRACP, National Cancer Centre, Singapore

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: July 13, 2011
• First Posted (Estimate): July 14, 2011

Study Record Updates

• Last Update Posted (Estimate): May 3, 2013
• Last Update Submitted That Met QC Criteria: May 2, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: breast cancer; response; neoadjuvant chemotherapy; diffuse optical tomography
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 11-7-BRE