Trial Outcomes & Findings for Fluorescence Imaging of Carcinoma During Breast Conserving Surgery (NCT NCT04815083)

NCT ID: NCT04815083

Last Updated: 2025-09-03

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 57 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2025-09-03

Participant Flow

Participants were recruited between 04/27/2021 and 08/30//2025. Patients were recruited by their surgeon at surgical clinic visits. Participants were recruited at each of the 7 study sites.

Fifty-seven (57) patients were enrolled for baseline characteristics as indicated in eligibility criteria prior to assignment in Part A of the study. Four (4) enrolled patients were excluded after enrollment due not meeting eligibility requirements. Three (3) patients who were enrolled were not completed due to a physician decision (1 patient) or a study pause (2 patients). The Part B (randomized and placebo controlled) was never initiated. The trial was terminated beforehand.

Participant milestones

Measure	PD G 506 A + Fluorescence-Guided Resection Arm 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.
Overall Study STARTED	57
Overall Study PD G 506 A + Fluorescence-Guided Resection Arm	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	PD G 506 A + Fluorescence-Guided Resection Arm 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.
Overall Study Physician Decision	1
Overall Study Study pause	2
Overall Study Screening failure	4

Baseline Characteristics

Fluorescence Imaging of Carcinoma During Breast Conserving Surgery

Baseline characteristics by cohort

Measure	PD G 506 A + Fluorescence-Guided Resection (Part A) n=57 Participants Patients in this arm received PD G 506 A orally approximately 3 hrs prior to anesthesia followed by standard of care BCS. Fluorescence imaging was be performed on tissue specimens resected prior to completion of standard of care resection. Fluorescence image-guided resection was performed after SoC BCS was complete.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants
Diagnosis Invasive carcinoma (± in situ carcinoma)	39 Participants n=5 Participants
Diagnosis In situ carcinoma	13 Participants n=5 Participants
Diagnosis Other (± in situ carcinoma)	4 Participants n=5 Participants
Diagnosis Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Patient-level specificity to identify residual carcinoma

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Patient-level sensitivity to identify residual carcinoma

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Orientation-level diagnostic performance of PD G 506 A-induced fluorescence to determine the presence or absence of cancer in the surgical cavity as compared to margin histopathology.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Percentage of patients with at least one histopathology-positive margin following SoC who then have ALL histopathology-negative margins following FGR, among all patients imaged.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Patient-level sensitivity, specificity, NPV, PPV of PD G 506 A-induced fluorescence to determine the presence or absence of residual cancer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Patient-level sensitivity, specificity, PPV and NPV to determine the presence or absence of residual cancer in the surgical cavity at the end of FGR (using modified patient-level definitions).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Patient-level sensitivity, specificity, PPV and NPV to determine the presence or absence of cancer in the surgical cavity after SoC BCS.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Patient-level sensitivity, specificity, PPV and NPV to determine the presence or absence of cancer in the surgical cavity after SoC (using modified patient-level definitions).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Percentage of patients assessed as residual tumor negative at the end of FGR who had positive final margins on histopathology.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Percentage of patients in whom SOC final margins were carcinoma negative and all FL-driven shave specimens are carcinoma-negative.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Percentage of patients with histopathology-negative margins at the end of SoC who have at least one orientation that was both FL-positive and histopathology-positive among (1) patients with histopathology negative final margins after SOC and (2) all patients imaged.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Percentage of patients with no fluorescence identified at the end of SoC in whom all final margins after SoC are histopathologically confirmed to be negative for carcinoma.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Patient-level in vivo diagnostic performance of PD G 506 A-induced fluorescence to determine the presence or absence of residual cancer in the surgical cavity at the end of FGR as compared to the final margin histopathology.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Percentage of orientations where in vivo and ex vivo fluorescence assessments are discordant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Percentage of patients receiving a 2nd surgery on the ipsilateral breast within 1 year of index BCS to remove suspected residual disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 - 6 months

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Percentage of patients receiving an early 2nd surgery (planned or actual) on the ipsilateral breast related to positive final margins.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 - 6 months

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Weight (mg) of all tissue removed based on SoC and/of FGR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks, 3-, 6- and 12-months

Population: The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed.

Patient satisfaction with the cosmetic outcome of breast conserving surgery performed based on SoC in combination with PD G 506 A and the Eagle V1.2 Imaging System.

Outcome measures

Outcome data not reported

Adverse Events

PD G 506 A + Fluorescence-Guided Resection Arm (Part A)

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure

PD G 506 A + Fluorescence-Guided Resection Arm (Part A) n=50 participants at risk 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. Aminolevulinic Acid Hydrochloride: 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. Eagle V1.2 Imaging System: 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.

Vascular disorders Hypotension

2.0% 1/50 • All adverse events were followed from the time of consent to through to the Week 2 visit (~14 days after surgery). If a serious or non-serious adverse event (AE) was recorded at the Week 2 visit, the participant was assessed for an additional 7 days for non-serious adverse events or for at least an additional 30 calendar days for serious adverse events following the Week 2 visit. Any serious adverse events were followed until resolution or stabilization.

Other adverse events

Measure	PD G 506 A + Fluorescence-Guided Resection Arm (Part A) n=50 participants at risk 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. Aminolevulinic Acid Hydrochloride: 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. Eagle V1.2 Imaging System: 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.
Skin and subcutaneous tissue disorders Photosensitivity reaction	8.0% 4/50 • Number of events 5 • All adverse events were followed from the time of consent to through to the Week 2 visit (~14 days after surgery). If a serious or non-serious adverse event (AE) was recorded at the Week 2 visit, the participant was assessed for an additional 7 days for non-serious adverse events or for at least an additional 30 calendar days for serious adverse events following the Week 2 visit. Any serious adverse events were followed until resolution or stabilization.
Injury, poisoning and procedural complications Procedural pain	16.0% 8/50 • Number of events 10 • All adverse events were followed from the time of consent to through to the Week 2 visit (~14 days after surgery). If a serious or non-serious adverse event (AE) was recorded at the Week 2 visit, the participant was assessed for an additional 7 days for non-serious adverse events or for at least an additional 30 calendar days for serious adverse events following the Week 2 visit. Any serious adverse events were followed until resolution or stabilization.
Gastrointestinal disorders Nausea	12.0% 6/50 • Number of events 6 • All adverse events were followed from the time of consent to through to the Week 2 visit (~14 days after surgery). If a serious or non-serious adverse event (AE) was recorded at the Week 2 visit, the participant was assessed for an additional 7 days for non-serious adverse events or for at least an additional 30 calendar days for serious adverse events following the Week 2 visit. Any serious adverse events were followed until resolution or stabilization.
Skin and subcutaneous tissue disorders Skin burning sensation	6.0% 3/50 • Number of events 3 • All adverse events were followed from the time of consent to through to the Week 2 visit (~14 days after surgery). If a serious or non-serious adverse event (AE) was recorded at the Week 2 visit, the participant was assessed for an additional 7 days for non-serious adverse events or for at least an additional 30 calendar days for serious adverse events following the Week 2 visit. Any serious adverse events were followed until resolution or stabilization.

Additional Information

Vice President Clinical Development & Regulatory Affairs

photonamic GmbH & Co. KG

Phone: +49 (0)4101 78539 09

Email: info@photonamic.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place