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

This study has been terminated.
Sponsor:
Collaborator:
National University, Singapore
Information provided by (Responsible Party):
Yap Yoon Sim, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier:
NCT01394315
First received: July 12, 2011
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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


Condition
Breast Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Centre, Singapore:

Primary Outcome Measures:
  • 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.



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 ] [ 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


Enrollment: 8
Study Start Date: August 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394315

Locations
Singapore
National Cancer Centre Singapore
Singapore, Singapore, 169610
Sponsors and Collaborators
National Cancer Centre, Singapore
National University, Singapore
Investigators
Principal Investigator: Yoon Sim Yap, MBBS, FRACP National Cancer Centre, Singapore
  More Information

No publications provided

Responsible Party: Yap Yoon Sim, Senior Consultant, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT01394315     History of Changes
Other Study ID Numbers: 11-7-BRE
Study First Received: July 12, 2011
Last Updated: May 2, 2013
Health Authority: Singapore: SingHealth Centralised Institutional Review Board

Keywords provided by National Cancer Centre, Singapore:
diffuse optical tomography
response
neoadjuvant chemotherapy
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014