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

Breast Neoplasms Clinical Trial

— DOT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01394315
• Other study ID #: 11-7-BRE
• Status: Terminated
• Phase: N/A
• First received: July 12, 2011
• Last updated: May 2, 2013
• Start date: August 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: National Cancer Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: SingHealth Centralised Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore	National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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).	These parameters will be obtained from patients during neoadjuvant chemotherapy process, which is up to an average of 6 months	No