Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer (DOT)
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The aim of the study is to determine if DOT can detect response early in breast cancer patients undergoing neoadjuvant chemotherapy.
Condition or disease
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.
Parameters derived from the optical images acquired with the DOT system [ Time Frame: 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 :
Change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation [ Time Frame: 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).
Biospecimen Retention: Samples With DNA
Pre-operative biopsy specimens and definitive surgical specimens
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Ages Eligible for Study:
21 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
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