Fluorescence Imaging of Carcinoma During Breast Conserving Surgery

NCT04815083 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: SBI-CIP 20-002
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Breast Neoplasm Female; Breast Cancer

Keywords

Breast conserving surgery; Fluorescence Imaging; Intraoperative margin assessment

Outcome Measures

Primary Outcomes (3)

• Positive Margin Conversion Rate

  Percentage of patients with negative-margins following fluorescence-guided resection (FGR) among patients all patients imaged

  2 weeks

• Diagnostic Performance (Specificity)

  Patient-level specificity to identify residual carcinoma

  2 weeks

• Diagnostic Performance (Sensitivity)

  Patient-level sensitivity to identify residual carcinoma

  2 weeks

Secondary Outcomes (16)

• Orientation-level Diagnostic Performance

  2 weeks

• Positive Margin Conversion Rate Among All Patients

  2 weeks

• Patient-level Diagnostic Performance

  2 weeks

• Patient-level Diagnostic Performance of PD G 506 A to Detect Residual Cancer at the End of FGR With Modified Patient-level Definitions

  2 weeks

• Patient-level Diagnostic Performance of PD G 506 A to Detect Cancer After SoC BCS

  2 weeks

Study Arms (2)

Standard of Care Arm

PLACEBO COMPARATOR

Patients in this arm will receive the placebo orally approximately 3 hrs prior to anesthesia followed by standard of care BCS. Fluorescence imaging will be performed on tissue specimens resected prior to completion of standard of care resection. Fluorescence-guided resection will not be performed in patients in this arm.

Drug: Placebo

PD G 506 A + Fluorescence-Guided Resection Arm

EXPERIMENTAL

Patients in this arm will receive PD G 506 A orally approximately 3 hrs prior to anesthesia followed by standard of care BCS. Fluorescence imaging will be performed on tissue specimens resected prior to completion of standard of care resection. Fluorescence imaging performed after SoC BCS is complete will guide the resection of additional tissue.

Drug: Aminolevulinic Acid Hydrochloride; Device: Eagle V1.2 Imaging System

Interventions

Aminolevulinic Acid Hydrochloride DRUG

PD G 506 A for oral solution (aminolevulinic acid \[ALA\] hydrochloride \[HCl\] granules for oral solution) is administered as a single dose (20 mg/kg body weight) approximately 3 hours (min 2 hours, max 4 hours) prior to anesthesia.

Also known as: PD G 506 A

PD G 506 A + Fluorescence-Guided Resection Arm

Eagle V1.2 Imaging System DEVICE

Fluorescence imaging camera and associated accessories used to view and capture fluorescence and white light images and videos of the surgical cavity and excised tissue specimens during the surgical procedure.

PD G 506 A + Fluorescence-Guided Resection Arm

Placebo DRUG

Oral placebo is administered as a single dose approximately 3 hours (min 2 hours, max 4 hours) prior to anesthesia.

Standard of Care Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• SBI ALApharma Canada, Inc.: lead

Study Sites (7)

Stamford Hospital

Stamford, Connecticut, 06902, United States

Location

BayCare Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Orlando Health, Inc.

Orlando, Florida, 32806, United States

Location

BayCare St. Joseph's Hospital

Tampa, Florida, 33607, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Aurora St. Luke's Medical Centre

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Study was terminated early prior to meeting expected enrolment for Part A. No formal data analysis was performed.

Results Point of Contact

• Title: Vice President Clinical Development & Regulatory Affairs
• Organization: photonamic GmbH & Co. KG

info@photonamic.de

+49 (0)4101 78539 09

Study Officials

• Ralph DaCosta, PhD

  SBI ALApharma Canada

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In Part B, the participant and pathologist will be blind to treatment arm allocation for the duration of the study. The surgeon will be blind to treatment arm allocation up until the time that standard of care resection is complete. The blind will be broken during the surgical procedure after the surgeon declares standard of care resection complete.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A of the study is open-label. All patients in Part A will receive the investigational drug and will undergo standard of care breast conserving surgery (BCS) followed by fluorescence-guided resection. Part B of the study is randomized and placebo controlled; patients will be randomized to receive placebo + standard of care BCS alone or PD G 506 A + SoC BCS followed by fluorescence-guided resection.

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: April 27, 2021
• Primary Completion: October 22, 2024
• Study Completion: December 20, 2024
• Last Updated: September 3, 2025
• Results First Posted: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)