Breast Neoplasm FemalePhase 3NCT04815083

Fluorescence Imaging of Carcinoma During Breast Conserving Surgery

A Phase 3 study testing Aminolevulinic Acid Hydrochloride and Eagle V1.2 Imaging System in people with Breast Neoplasm Female and Breast Cancer, run by SBI ALApharma Canada, Inc. at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Neoplasm Female, Breast Cancer
What is being tested?: Aminolevulinic Acid Hydrochloride and Eagle V1.2 Imaging System
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 7 sitesUnited States
Study dates: 27 Apr 2021to 20 Dec 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 31Show fewer

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:
Bilirubin: Above upper limit of normal
Aspartate aminotransferase (SGOT): > 2.5 X institutional upper limit of normal
Alanine aminotransferase ( (SGPT): > 2.5 X institutional upper limit of normal
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.
Uncontrolled concurrent illness, that in the opinion of the Investigator would prevent the patient from participation in the study, including but not limited to:
Ongoing or active infection;
Cardiovascular disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia).
Patients who have the following collagen vascular diseases:
Lupus
Scleroderma
Use of an investigational drug within 30 days of their scheduled surgical procedure
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.
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)
Patients who are pregnant or become pregnant (it is unknown if ALA HCl is teratogenic or has abortifacient effects)
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)
Inability to consent

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

BayCare Morton Plant Hospital
Clearwater, Florida, 33756
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Aurora St. Luke's Medical Centre
Milwaukee, Wisconsin, 53215
Orlando Health, Inc.
Orlando, Florida, 32806
Stamford Hospital
Stamford, Connecticut, 06902
BayCare St. Joseph's Hospital
Tampa, Florida, 33607
Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

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

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.

Read the detailed description

Re-operations due to positive margins following breast conserving surgery (BCS) increase poor cosmesis, complications, discomfort, stress, adjuvant delay, medical costs and risk of local recurrence. Reducing positive margin rates can be achieved through optimizing surgical procedures. This study evaluates a new method for surgeons to visualize carcinoma in real-time, both in the surgical cavity and on the margins of excised specimen(s) during the index BCS procedure.

The active ingredient of PD G 506A is aminolevulinic acid hydrochloride (ALA HCl). ALA HCl is a prodrug that is metabolized intracellularly to form the fluorescent molecule protoporphyrin IX (PpIX). The exogenous application of ALA HCl leads to a highly selective accumulation of PpIX in malignant tissues.

This Phase 3, 2-part, single-blind [pathologist(s)-blinded] randomized placebo-controlled trial study is designed to evaluate the efficacy and safety of PD G 506 A to aid in the visualization of carcinoma during BCS. The Eagle V1.2 Imaging System will be used in this trial to visualize PpIX fluorescence.

Part A is an open-label training phase of the study to optimize workflow and Part B of the study is randomized and single-blind and will serve as the pivotal portion of the study.

Conditions: Breast Neoplasm Female, Breast Cancer
Being tested: Aminolevulinic Acid Hydrochloride, Eagle V1.2 Imaging System, Placebo
Keywords: Breast conserving surgery, Fluorescence Imaging, Intraoperative margin assessment
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aminolevulinic Acid HydrochlorideDrug
Also called PD G 506 A
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 SystemDevice
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.
PlaceboDrug
Oral placebo is administered as a single dose approximately 3 hours (min 2 hours, max 4 hours) prior to anesthesia.

Study groups in NCT04815083
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Aminolevulinic Acid Hydrochloride; Device: Eagle V1.2 Imaging System

What is being measured

The primary outcome is the main question the study is designed to answer.

Positive Margin Conversion Rate
Percentage of patients with negative-margins following fluorescence-guided resection (FGR) among patients all patients imaged
Measured: 2 weeks
Diagnostic Performance (Specificity)
Patient-level specificity to identify residual carcinoma
Measured: 2 weeks
Diagnostic Performance (Sensitivity)
Patient-level sensitivity to identify residual carcinoma
Measured: 2 weeks

Secondary outcomes (16)

Orientation-level Diagnostic Performance
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.
Measured: 2 weeks
Positive Margin Conversion Rate Among All Patients
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.
Measured: 2 weeks
Patient-level Diagnostic Performance
Patient-level sensitivity, specificity, NPV, PPV of PD G 506 A-induced fluorescence to determine the presence or absence of residual cancer.
Measured: 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
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).
Measured: 2 weeks
Patient-level Diagnostic Performance of PD G 506 A to Detect Cancer After SoC BCS
Patient-level sensitivity, specificity, PPV and NPV to determine the presence or absence of cancer in the surgical cavity after SoC BCS.
Measured: 2 weeks
Patient-level Diagnostic Performance of PD G 506 A to Detect Cancer After SoC With Modified Patient-level Definitions
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).
Measured: 2 weeks
Patient-level False Negative Rate of at the End of FGR
Percentage of patients assessed as residual tumor negative at the end of FGR who had positive final margins on histopathology.
Measured: 2 weeks
Patient-level False Positive Rate
Percentage of patients in whom SOC final margins were carcinoma negative and all FL-driven shave specimens are carcinoma-negative.
Measured: 2 weeks
Patients With Carcinoma-negative Margins After SoC Found to Have Residual Tumor Following SoC That Was Identified With FL Imaging
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.
Measured: 2 weeks
Patient-level True Negative Rate at the End of SoC
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.
Measured: 2 weeks
Patient-level Diagnostic Performance to Identify in Vivo Residual Carcinoma After FGR
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.
Measured: 2 weeks
Orientation Discordant Fluorescence Status
Percentage of orientations where in vivo and ex vivo fluorescence assessments are discordant.
Measured: 2 weeks
Patient-level Re-operation Rate
Percentage of patients receiving a 2nd surgery on the ipsilateral breast within 1 year of index BCS to remove suspected residual disease.
Measured: 1 year
Patient-level Early Re-operation Rate
Percentage of patients receiving an early 2nd surgery (planned or actual) on the ipsilateral breast related to positive final margins.
Measured: 3 - 6 months
Amount of Tissue Removed With FGR Beyond SoC
Weight (mg) of all tissue removed based on SoC and/of FGR.
Measured: 3 - 6 months
Patient Satisfaction With Breast
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.
Measured: 2 weeks, 3-, 6- and 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Apr 202120 Dec 2024

First posted24 Mar 2021
Study start27 Apr 2021
Primary completion22 Oct 2024
Study completion20 Dec 2024

Why it stopped: Study terminated due to closure of Sponsor business

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: 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.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04815083
Sponsor's protocol ID: SBI-CIP 20-002
Status last verified: Aug 2025
First submitted: 22 Mar 2021
Last updated: 3 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04815083
Acronym / sponsor ID: SBI-CIP 20-002
Conditions: Breast Neoplasm Female, Breast Cancer
Keywords: Breast conserving surgery, Fluorescence Imaging, Intraoperative margin assessment
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated due to closure of Sponsor business
Enrolment: 57 participants (actual)
Lead sponsor: SBI ALApharma Canada, Inc.Industry (pharma, biotech, devices)
Study start: 27 Apr 2021 (actual)
Primary completion: 22 Oct 2024 (actual)
Study completion: 20 Dec 2024 (actual)
First posted: 24 Mar 2021 (actual)
Results: Posted 3 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Part A is an open-label training phase of the study to optimize workflow and Part B of the study is randomized and single-blind and will serve as the pivotal portion of the study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Standard of Care Arm	Placebo comparator	Drug: PlaceboPatients 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.
PD G 506 A + Fluorescence-Guided Resection Arm	Experimental	Drug: Aminolevulinic Acid Hydrochloride, Device: Eagle V1.2 Imaging SystemPatients 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (31 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aminolevulinic Acid HydrochlorideAlso: PD G 506 APD 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.	Drug	PD G 506 A + Fluorescence-Guided Resection Arm
Eagle V1.2 Imaging SystemFluorescence 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.	Device	PD G 506 A + Fluorescence-Guided Resection Arm
PlaceboOral placebo is administered as a single dose approximately 3 hours (min 2 hours, max 4 hours) prior to anesthesia.	Drug	Standard of Care Arm

Primary outcome

Positive Margin Conversion Rate
Time frame: 2 weeks
Percentage of patients with negative-margins following fluorescence-guided resection (FGR) among patients all patients imaged
Diagnostic Performance (Specificity)
Time frame: 2 weeks
Patient-level specificity to identify residual carcinoma
Diagnostic Performance (Sensitivity)
Time frame: 2 weeks
Patient-level sensitivity to identify residual carcinoma

16 secondary outcomes

Orientation-level Diagnostic Performance
Time frame: 2 weeks
Positive Margin Conversion Rate Among All Patients
Time frame: 2 weeks
Patient-level Diagnostic Performance
Time frame: 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
Time frame: 2 weeks
Patient-level Diagnostic Performance of PD G 506 A to Detect Cancer After SoC BCS
Time frame: 2 weeks
Patient-level Diagnostic Performance of PD G 506 A to Detect Cancer After SoC With Modified Patient-level Definitions
Time frame: 2 weeks
Patient-level False Negative Rate of at the End of FGR
Time frame: 2 weeks
Patient-level False Positive Rate
Time frame: 2 weeks
Patients With Carcinoma-negative Margins After SoC Found to Have Residual Tumor Following SoC That Was Identified With FL Imaging
Time frame: 2 weeks
Patient-level True Negative Rate at the End of SoC
Time frame: 2 weeks
Patient-level Diagnostic Performance to Identify in Vivo Residual Carcinoma After FGR
Time frame: 2 weeks
Orientation Discordant Fluorescence Status
Time frame: 2 weeks
Patient-level Re-operation Rate
Time frame: 1 year
Patient-level Early Re-operation Rate
Time frame: 3 - 6 months
Amount of Tissue Removed With FGR Beyond SoC
Time frame: 3 - 6 months
Patient Satisfaction With Breast
Time frame: 2 weeks, 3-, 6- and 12-months

Results and safety

Results posted to the registry on 3 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PD G 506 A + Fluorescence-Guided Resection Arm	57	50

Primary outcome: Positive Margin Conversion Rate

Time frame: 2 weeks

Population analysed: 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.

Primary outcome: Diagnostic Performance (Specificity)

Time frame: 2 weeks

Primary outcome: Diagnostic Performance (Sensitivity)

Time frame: 2 weeks

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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 reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PD G 506 A + Fluorescence-Guided Resection Arm (Part A)	1 of 50 (2%)	16 of 50 (32%)	0 of 50

Limitations and caveats (from the sponsor): Study was terminated early prior to meeting expected enrolment for Part A. No formal data analysis was performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ralph DaCosta, PhD study director

SBI ALApharma Canada

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Margin Conversion Rate (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04815083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.