Fluorescence Imaging to Help Remove Cancer During Breast Surgery

Sponsor: SBI ALApharma Canada, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04815083

Provider View

This study is testing a new imaging method to help surgeons see and remove all cancer during breast-conserving surgery, potentially reducing the need for additional surgeries.

Patient Parameters

Program Overview

Breast-conserving surgery aims to remove breast cancer while keeping as much healthy tissue as possible. However, it's often hard for surgeons to know if they've removed all the cancer during the operation, which can lead to more surgeries. This Phase 3 study is testing a new imaging agent, PD G 506 A, that helps visualize cancer in real-time during surgery. PD G 506 A turns into a fluorescent molecule in the body that lights up cancer cells, helping surgeons see and remove any remaining cancerous tissue during the procedure.

Description

When breast-conserving surgery doesn't remove all the cancer, it can lead to more surgeries, increased stress, and higher medical costs. This study is testing a new method to help surgeons see cancer in real-time during the initial surgery. The imaging agent, PD G 506 A, contains a substance called aminolevulinic acid hydrochloride (ALA HCl), which turns into a fluorescent molecule that accumulates in cancer cells. This helps surgeons see cancerous areas more clearly.

The study is in two parts: Part A is a training phase to optimize the process, and Part B is a randomized trial to test the effectiveness and safety of PD G 506 A. The Eagle V1.2 Imaging System will be used to visualize the fluorescence during surgery.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Diagnosed with primary breast cancer, including various types like invasive ductal carcinoma and ductal carcinoma in situ.
  • Scheduled for a lumpectomy (breast-conserving surgery).
  • Must have normal organ and bone marrow function and be a suitable candidate for surgery.
  • Women of childbearing potential must agree to use effective birth control during the study.

Exclusion Criteria

  • Currently receiving treatment for another cancer.
  • Planning to receive pre-surgery treatment for breast cancer.
  • Have stage 4 cancer or non-invasive breast diseases.
  • Have had certain breast procedures or surgeries within specific timeframes.
  • Have a history of allergic reactions to the study drug or similar substances.
  • Have certain medical conditions or lab results outside normal ranges.
  • Pregnant or breastfeeding women.
  • Unable to consent or comply with study requirements.

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