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| Name | Class |
|---|---|
| National University of Singapore | OTHER |
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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.
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.
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| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Yoon Sim Yap, MBBS, FRACP | National Cancer Centre, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Centre Singapore | Singapore | Singapore | 169610 | Singapore |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Pre-operative biopsy specimens and definitive surgical specimens
| These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |