Know Cancer

or
forgot password

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


N/A
21 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Parameters derived from the optical images acquired with the DOT system

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Yoon Sim Yap, MBBS, FRACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Centre, Singapore

Authority:

Singapore: SingHealth Centralised Institutional Review Board

Study ID:

11-7-BRE

NCT ID:

NCT01394315

Start Date:

August 2011

Completion Date:

May 2013

Related Keywords:

  • Breast Neoplasms
  • diffuse optical tomography
  • response
  • neoadjuvant chemotherapy
  • breast cancer
  • Breast Neoplasms
  • Neoplasms

Name

Location