Fluorescence imaging of carcinoma during breast conserving surgery
A prospective multi-center clinical study evaluating the use of PD G 506 A and the Eagle V1.2 Imaging System for the visualization of carcinoma during breast conserving surgery
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Clinical Trial Information
Trial Contact: Durand, Jennifer; Ribacchi, Stephanie; Porter, Janice (Melinda)
Trial Phone: 321.843.2026 ; 321-841-1077 ; 321.841.1077
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IRB No: Pro00048540
Protocol Abbrev: SBI-CIP-20-002
Principal Investigator: Terry P. Mamounas, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: SBI ALApharma
Treatment: Arm 1 (SoC): placebo + conventional BCS (data from this arm will not be analyzed for the primary or secondary efficacy endpoints) Arm 2 (experimental): PD G 506 A (20 mg/kg) + conventional BCS + Eagle V1.2 intraoperative imaging
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT04815083
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Objective
This Phase 3 study will evaluate the safety and patient-level clinical usefulness, as well as patient and margin-level diagnostic performance of PD G 506 A (ALA HCl granules for oral solution)-induced fluorescence for the real-time detection of carcinoma during standard of care (SoC) BCS.
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Key Eligibility
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
4. Patient must have normal organ and bone marrow function and be an 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)
Subject exclusion criteria
Disease and SoC treatment:
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 phyllodes, Paget’s disease of the breast, lobular carcinoma in situ)
5. Patients who have had previous surgery on the involved breast including breast surgeries, mastectomies, breast reconstructions or implants
6. Patients for whom intraoperative frozen section analysis is planned
