Fluorescence Imaging of Carcinoma During Breast Conserving Surgery
Public ClinicalTrials.gov record NCT04815083. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04815083
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 57 participants
Conditions and interventions
Conditions
Interventions
- Aminolevulinic Acid Hydrochloride Drug
- Eagle V1.2 Imaging System Device
- Placebo Drug
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 27, 2021 (Actual)
- Primary completion
- Oct 22, 2024 (Actual)
- Completion
- Dec 20, 2024 (Actual)
- Last update posted
- Sep 3, 2025
2021 – 2024
United States locations
- U.S. sites
- 7
- U.S. states
- 4
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stamford Hospital | Stamford | Connecticut | 06902 | — |
| BayCare Morton Plant Hospital | Clearwater | Florida | 33756 | — |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Orlando Health, Inc. | Orlando | Florida | 32806 | — |
| BayCare St. Joseph's Hospital | Tampa | Florida | 33607 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Aurora St. Luke's Medical Centre | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04815083, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 3, 2025 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04815083 live on ClinicalTrials.gov.