Know Cancer

forgot password

ALA-induced Fluorescence Imaging of Breast Cancers Using the Handheld PRODIGI Imaging Device

18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

ALA-induced Fluorescence Imaging of Breast Cancers Using the Handheld PRODIGI Imaging Device

Inclusion Criteria:

1. Female patients with breast cancer

2. 18 years or older

3. Have consented for their standard surgeries for primary invasive breast cancers, with
or without auxiliary procedure.

4. Have existing biopsies banked at the hospital (for ALA patients)

Exclusion Criteria:

1. Pre-operative therapy (including chemotherapy, endocrine therapy and radiotherapy)

2. Inability to consent

3. Prior history of photosensitivity, liver disease, or recurrent disease

4. Pregnancy

5. Absence of in-house core biopsy in tissue bank

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The sensitivities and specificities for the two (oral) doses of 5-ALA (15 mg/kg and 30 mg/kg) and control (0 mg/kg ALA) in differentiating cancer/normal tissue.

Outcome Description:

The sensitivity and specificity of fluorescence imaging for differentiating cancer from normal tissue in the breast will be evaluated by tissue histopathology and compared to standard white-light imaging. The sensitivities and specificities for auto-fluorescence (Cohort 1: 0 mg/kg 5-ALA) will be compared to the sensitivities and specificities of the two doses of 5-ALA (Cohort 2: 15mg/kg and Cohort 3: 30mg/kg). In addition, the sensitivities and specificities between the two 5-ALA dosing cohorts will be compared.

Outcome Time Frame:

The fluorescence and white-light images will be evaluated and compared to histopathology within an average of 2 months after the surgery. The sensitivities and specificities will be calculated within 4 months of achieving a full dataset (45 patients).

Safety Issue:


Principal Investigator

Ralph S DaCosta, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Health Canada

Study ID:




Start Date:

September 2010

Completion Date:

May 2015

Related Keywords:

  • Breast Cancer
  • Fluorescence Imaging
  • Breast Tumor Margins
  • Real-time Assessment
  • Breast Neoplasms