Clinical trial NCT01394315: Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer
Official title: Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Neoplasms
Keywords: diffuse optical tomography
response
neoadjuvant chemotherapy
breast cancer
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2011-07-14
Enrollment: 8
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parameters derived from the optical images acquired with the DOT system
timeFrame: These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
Secondary outcomes:
measure: Change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation
timeFrame: These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Yoon Sim Yap, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References: