Phase 3 Clinical Trial

SBI ALApharma Canada Inc's
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

More information at

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.

A specimen imaged under blue light producing bright red fluorescence

The Eagle Imaging

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.

Learn More About Becoming a Study Site →


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:

Interested in becoming
a clinical partner?

We are currently recruiting new clinical sites in the USA and Canada.

Are you a surgeon who performs breast-conserving lumpectomies at your institution?

Do you wish to learn more about this clinical trial? Please fill in your details here. Our clinical team will reach out to you about becoming a site with this Phase III clinical trial.

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.