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

NCT01394315 | Terminated

• 1 other identifier: 11-7-BRE
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Neoplasms

Keywords

diffuse optical tomography; response; neoadjuvant chemotherapy; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in DOT parameters such as BVI, SO2, blood perfusion dynamic fluctuation

  These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National Cancer Centre Singapore

Singapore, Singapore, 169610, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pre-operative biopsy specimens and definitive surgical specimens

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yoon Sim Yap, MBBS, FRACP

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 14, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

SG (1)