Using fluorescence imaging to improve breast cancer surgery outcomes
ALA-induced Fluorescence Imaging of Breast Cancers Using the Handheld PRODIGI and Eagle Imaging Devices
University Health Network, Toronto · NCT01837225
This study is testing a new imaging tool to see if using a special dye during breast cancer surgery can help doctors find tumors better and reduce the need for extra surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Health Network, Toronto (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT01837225 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance breast cancer surgery by utilizing a handheld optical imaging device called PRODIGI, which detects fluorescence signals in breast tissue. The study will assess the effectiveness of a contrast agent, 5-ALA, in increasing the visibility of tumor margins compared to standard white light. Patients will be divided into cohorts receiving different doses of 5-ALA during their breast conservation surgery, allowing researchers to evaluate the optimal dose for improving tumor detection. The ultimate goal is to reduce the need for additional surgeries by improving the identification of cancerous tissue during the initial operation.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older with primary invasive breast cancer who have consented to standard surgical procedures.
Not a fit: Patients who have undergone pre-operative therapy or have conditions such as photosensitivity or liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly reduce the likelihood of cancer recurrence and the need for follow-up surgeries.
How similar studies have performed: Previous studies have shown promise in using fluorescence imaging for tumor detection, but this specific approach with PRODIGI and 5-ALA is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario and 1 other locations
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (ENROLLING_BY_INVITATION)
- Princess Margaret Hospital — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Ralph S DaCosta, PhD — University Health Network, Toronto
- Study coordinator: Ralph S DaCosta, PhD
- Email: ralph.dacosta@uhnresearch.ca
- Phone: (416) 581 8645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Fluorescence Imaging, Breast Tumor Margins, Real-time Assessment