Phase 3 Clinical Trial
Randomized Phase 3 Clinical Trial
Pivotal Phase III Study to Evaluate Real-Time Intraoperative Fluorescence Visualization of Cancer
SBI ALApharma Canada Inc. is currently performing a pivotal Phase III randomized controlled clinical trial. This trial will evaluate the safety and efficacy of the imaging agent PD G 506 A (5-Aminolevulinic Acid) during breast conserving surgery, for real-time intraoperative fluorescence visualization of cancer.
Study details can be found at
the FDA’s clinical trial page
Fluorescence Imaging of Carcinoma During Breast Conserving Surgery
Approximately 1 in 5 women still require a second surgery, following their index breast conserving surgery, in order to achieve clean surgical margins. SBI ALApharma Canada Inc. recognizes this un-met need. It is our mission to address this requirement in care - by providing breast cancer surgeons with the ability to visualize residual disease in real-time during index breast cancer surgeries. Driven by this mission, SBI ALApharma Canada Inc. is conducting a pivotal Phase III clinical trial to assess the use of fluorescence-guided surgery for breast cancer patients.
This clinical trial will collect data on the use of PD G 506 A (investigational drug) and the Eagle V1.2 Imaging System (investigational device) to evaluate intra-operative real-time fluorescent visualization of cancer during breast lumpectomy surgeries.
Learn more about SBI ALApharma Canada Inc.’s approach to improving margin assessment.→
5-Aminolevulinic Acid Hydrochloride
PD G 506 A (aminolevulinic acid hydrochloride granules for oral solution) is an investigational pro- drug. It is converted in the body into protoporphyrin IX (PpIX), a molecule that builds-up in cancer cells, and produces bright red fluorescence when exposed to blue light.
The Eagle Imaging
SystemTM
The Eagle V1.2 Imaging SystemTM is an investigational intraoperative fluorescence imaging device, which will be used in this trial to visualize the distinct red fluorescence produced by cancer cells, against the natural green fluorescence of healthy breast tissues.
Clinical Trial Overview
In this Phase III clinical trial, patients receiving PD G 506 A will undergo standard of care breast conserving surgery. After standard of care surgery has been completed, fluorescence imaging will be conducted, and any potentially cancerous red fluorescent tissue left behind in the surgical cavity will be removed.
The goal of this trial is to determine whether visualization of PD G 506 A-induced fluorescence during standard of care breast lumpectomy results in a lower number of positive margins, due to improved resection of cancerous tissue during initial breast conserving surgery.
SBI ALApharma Canada Inc. has obtained regulatory authorization from both FDA and Health Canada for the use of the investigational imaging agent and device, and has already partnered with several hospitals in North America to conduct this trial. We anticipate 20 sites in total to participate in this trial.
Clinical Trial Sites
SBI ALApharma Canada Inc. is working with -breast cancer surgeons at cancer centers across North America to conduct this pivotal Phase III clinical trial. Study sites currently include:
