A Prototype Tri-modal Imaging Device for Breast Cancer

University Health Network, Toronto

Status and phase

Completed

Phase 1

Conditions

Primary Invasive Breast Cancer

Breast Cancer Invasive Nos

Treatments

Device: Tri-modal imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT02794064

14-8692

Details and patient eligibility

About

Breast conservation surgery (BCS) is performed on patients with breast cancer with the intent to resect and completely remove the tumour while conserving as much of the surrounding normal tissue as possible. Currently, there is no way for surgeons to determine the adequacy of surgical resection in real-time during surgery; the assessment of surgical margins requires histological examination that is not available in real-time and is impractical in most clinical cases. This results in a re-excision rate of 23% among Canadian women in order to achieve optimal surgical margins. In addition, the presence or absence of cancer in tumor draining lymph nodes is recognized as a key element for breast cancer staging; however, lymph node dissection can be associated with overtreatment and morbidity (nerve damage and post surgical lymphedema) and histological analysis of nodes can be time consuming and thus delay subsequent procedures. In an effort to address these issues, we have designed and constructed, in collaboration with Sogang University, Seoul, S. Korea, a novel imaging system that performs three complementary imaging modalities (tri-modal): ultrasound (US), photoacoustic (PA) and fluorescence (FL).

This first-in-human pilot study will recruit 10 breast cancer patients undergoing breast conserving surgery at Princess Margaret Hospital (Toronto, Canada). The study is designed to test our tri-modal (US, PA, FL) imaging technology in breast cancer patients. The overall goal is to obtain initial information on the technical feasibility of the tri-modal system in a peri-operative setting and to confirm the anticipated safety of the procedures. Additionally, it will provide initial data on the ability of this system to detect/localize primary breast cancer lesions and cancer-involved lymph nodes prior to surgery.

Enrollment

5 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female patients with biopsy-confirmed first primary invasive unilateral breast cancer
18 years of age or older
Have consented to standard of care surgery (lumpectomy, mastectomy) for primary invasive breast cancer, with or without auxiliary lymph node dissection
Have had pre-surgical imaging of the affected breast and (where applicable) lymph notes (Note: additional imaging may also be done day of scheduled surgery i.e. mammography, nuclear medicine)
Have existing biopsies banked at the hospital
Surgery scheduled at Princess Margaret Hospital
Tumor size of 1 cm or larger

Exclusion criteria

Inability to provide informed consent
Pre-operative therapy for current breast cancer (including chemotherapy, endocrine therapy and radiotherapy)
history of other previous cancer requiring therapy (including chemotherapy, endocrine therapy and radiotherapy) within the past 12 months
History of photosensitivity, skin disease or recurrent disease
Pregnancy
Absence of in-house biopsy in tissue bank
Bilateral breast cancer