Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer
The aim of the study is to determine if DOT can detect response early in breast cancer patients undergoing neoadjuvant chemotherapy.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer|
- 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 ] [ Designated as safety issue: No ]
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.
- 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 ] [ Designated as safety issue: No ]
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
|Study Start Date:||August 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394315
|National Cancer Centre Singapore|
|Singapore, Singapore, 169610|
|Principal Investigator:||Yoon Sim Yap, MBBS, FRACP||National Cancer Centre, Singapore|