Fluorescence Imaging of Carcinoma During Breast Conserving Surgery

Launched by SBI ALAPHARMA CANADA, INC. · Mar 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique that uses a special fluorescent agent called PD G 506 A to help surgeons see cancer cells during breast-conserving surgery. The goal is to ensure that all cancerous tissue is removed in one procedure, reducing the need for additional surgeries. Currently, surgeons can't always tell if they have completely removed the cancer while performing the surgery, which can lead to extra operations. By using this fluorescent agent, which highlights cancer cells, doctors hope to improve the accuracy of their surgery and help patients avoid the stress and recovery time associated with repeat procedures.

To be eligible for this trial, participants must be women aged 18 or older with confirmed breast cancer who are scheduled for a lumpectomy, which is a surgery to remove the cancer while preserving as much healthy breast tissue as possible. Participants should also be in good overall health and not currently receiving treatment for another type of cancer. If you join the study, you will receive the standard surgery and then the fluorescent imaging to check for any remaining cancer cells. It's an opportunity to potentially benefit from a new technique that aims to improve surgical outcomes for breast cancer patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Female, 18 years or older
• • 2. 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)
• • 3. 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).
• • 4. Patient must have normal organ and bone marrow function and be appropriate surgical candidate per site standard of care
• • 5. 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)
• Exclusion Criteria:
• • 1. Currently on (neo)adjuvant therapy to treat another cancer
• • 2. Receiving or intended to receive neoadjuvant therapy to treat the primary breast cancer (including chemotherapy, endocrine therapy and radiotherapy)
• • 3. Stage 4 cancer, inclusive of metastatic disease
• • 4. Non-invasive diseases of the breast (includes lobular carcinoma in situ, phyllodes and Paget's disease of the breast)
• 5. Patients who have had the following procedures performed on the involved breast:
• • 1. Surgery for a benign lesion(s) within 1 year of the BCS date
• • 2. Breast implants inserted within 1 year of the BCS date
• • 3. Breast reduction, surgery for malignant disease or mastectomy (at any time prior to the BCS date)
• • 4. 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
• • 5. Radiation at any time prior to the BCS date and who have signs of ongoing inflammation, active tissue healing and/or extensive scarring
• • 6. Patients for whom intraoperative frozen section analysis is planned
• • 7. 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
• • 8. History of hypersensitivity to ALA HCl or porphyrins
• • 9. Known or documented personal or family history of porphyria
• 10. Patient has a recording of any parameter as defined below:
• • 1. Bilirubin: Above upper limit of normal
• • 2. Aspartate aminotransferase (SGOT): \> 2.5 X institutional upper limit of normal
• • 3. Alanine aminotransferase ( (SGPT): \> 2.5 X institutional upper limit of normal
• • 11. 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.
• 12. Uncontrolled concurrent illness, that in the opinion of the Investigator would prevent the patient from participation in the study, including but not limited to:
• • 1. Ongoing or active infection;
• • 2. Cardiovascular disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia).
• 13. Patients who have the following collagen vascular diseases:
• • 1. Lupus
• • 2. Scleroderma
• • 14. Use of an investigational drug within 30 days of their scheduled surgical procedure
• • 15. Simultaneous use of other potentially phototoxic substances (such as St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period.
• • 16. Social or medical situations including uncontrolled psychiatric illnesses that would in the opinion of the Investigator limit compliance with study requirements (e.g. ability to travel for follow-up)
• • 17. Patients who are pregnant or become pregnant (it is unknown if ALA HCl is teratogenic or has abortifacient effects)
• • 18. Patients who are breast feeding (there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ALA HCl, breastfeeding should be discontinued if the mother is treated with ALA HCl)
• • 19. Inability to consent