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

Terminated

• Conditions: Breast Neoplasms

• Registration Number: NCT01394315
• Lead Sponsor: National Cancer Centre, Singapore

Brief Summary

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

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 Timeline

• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Study Start: 2011-08
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-02
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parameters derived from the optical images acquired with the DOT system	These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation	These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months	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).

Trial Locations

Locations (1)

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore