Fluorescence Imaging of Carcinoma During Breast Conserving Surgery

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Breast Neoplasm Female, Breast Cancer

In brief

Breast conserving surgery (BCS) is performed on patients with breast cancer to resect and completely remove the cancer while conserving as much of the surrounding healthy tissue as possible. Current methods do not allow surgeons to determine the completeness of surgical resection in real-time. This often results in the need for a second surgical procedure, or in some cases more than two surgical procedures in order to have confidence that all cancer has been removed. This Phase 3 study will evaluate the safety and efficacy of the fluorescent imaging agent PD G 506 A for the real-time visualization of cancer during standard of care breast conserving surgery. PD G 506 A is an investigational drug which is converted in the body into a fluorescent molecule that accumulates in cancer cells. Patients receiving PD G 506 A will undergo standard of care breast conserving surgery followed by fluorescence imaging and removal of any potentially cancerous tissue left behind in the surgical cavity.

Key facts

Study ID

NCT04815083

Run by

SBI ALApharma Canada, Inc.

People needed

57

Starts

2021-04-27

Expected to finish

2024-12-20

Last updated by the study team

2025-09-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female, 18 years or older
• Histologically or cytologically confirmed primary breast cancer (includes invasive lobular carcinoma, invasive ductal carcinoma, inflammatory breast cancer, papillary breast cancer, adenoid cystic carcinoma of the breast, mucinous breast cancer, metaplastic breast cancer, cribriform carcinoma and ductal carcinoma in situ, alone or in combination with invasive disease)
• Scheduled for a lumpectomy (including bilateral lumpectomy) of a breast malignancy (eligibility for breast conserving surgery/partial mastectomy based on clinical staging using TNM staging system (AJCC Cancer Staging Manual: Breast Cancer, 8th Edition70).
• Patient must have normal organ and bone marrow function and be appropriate surgical candidate per site standard of care
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) starting the day entering the study, and for the duration of the study period (until the Week 2 visit)

You may not qualify if…

• Currently on (neo)adjuvant therapy to treat another cancer
• Receiving or intended to receive neoadjuvant therapy to treat the primary breast cancer (including chemotherapy, endocrine therapy and radiotherapy)
• Stage 4 cancer, inclusive of metastatic disease
• Non-invasive diseases of the breast (includes lobular carcinoma in situ, phyllodes and Paget's disease of the breast)
• Patients who have had the following procedures performed on the involved breast:
• Surgery for a benign lesion(s) within 1 year of the BCS date
• Breast implants inserted within 1 year of the BCS date
• Breast reduction, surgery for malignant disease or mastectomy (at any time prior to the BCS date)
• Surgery for a benign lesion(s) or insertion of implants >1 year prior to the BCS date and who have signs of ongoing inflammation, active tissue healing and/or extensive scarring
• Radiation at any time prior to the BCS date and who have signs of ongoing inflammation, active tissue healing and/or extensive scarring
• Patients for whom intraoperative frozen section analysis is planned
• Patients who have not recovered from adverse events due an investigational pharmaceutical or diagnostic agents administered more than 30 days prior to their scheduled surgical procedure
• History of hypersensitivity to ALA HCl or porphyrins
• Known or documented personal or family history of porphyria
• Patient has a recording of any parameter as defined below:
• Bilirubin: Above upper limit of normal
• Aspartate aminotransferase (SGOT): > 2.5 X institutional upper limit of normal
• Alanine aminotransferase ( (SGPT): > 2.5 X institutional upper limit of normal
• Patient has serum creatinine >1.5 times institutional upper limit of normal, OR calculated creatinine clearance > 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal.
• Uncontrolled concurrent illness, that in the opinion of the Investigator would prevent the patient from participation in the study, including but not limited to:
• Ongoing or active infection;
• Cardiovascular disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia).
• Patients who have the following collagen vascular diseases:
• Lupus
• Scleroderma

Where it is running

• Stamford Hospital — Stamford, Connecticut, United States
• BayCare Morton Plant Hospital — Clearwater, Florida, United States
• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Orlando Health, Inc. — Orlando, Florida, United States
• BayCare St. Joseph's Hospital — Tampa, Florida, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Aurora St. Luke's Medical Centre — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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