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Fluorescence Imaging for Breast Cancer

Phase 3

Recruiting

Research Sponsored by SBI ALApharma Canada, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for a lumpectomy (including bilateral lumpectomy) of a breast malignancy

Female, 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will help to determine if PD G 506 A can help surgeons to more effectively remove all cancerous tissue during breast conserving surgery, potentially reducing the need for additional surgeries.

Who is the study for?

This trial is for women aged 18 or older with confirmed primary breast cancer, scheduled for lumpectomy. They must have normal organ and bone marrow function and not be pregnant or breastfeeding. Participants should agree to use contraception and cannot have stage 4 cancer, recent investigational drug use, collagen diseases, or need neoadjuvant therapy.Check my eligibility

What is being tested?

The study tests the PD G 506 A fluorescent imaging agent's safety and effectiveness during breast conserving surgery. It aims to help surgeons see cancer in real-time to potentially reduce the need for additional surgeries by highlighting remaining cancerous tissue after initial removal.See study design

What are the potential side effects?

Possible side effects include reactions related to hypersensitivity to ALA HCl or porphyrins (components of PD G 506 A), which may cause issues like skin sensitivity, especially under light exposure due to the drug's fluorescent properties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery to remove a breast tumor.

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I am a woman aged 18 or older.

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My organs and bone marrow function normally, and I am fit for surgery.

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My breast cancer diagnosis was confirmed through tissue examination.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Diagnostic performance (Sensitivity)

Diagnostic performance (Specificity)

Positive margin conversion rate

Secondary outcome measures

Amount of tissue removed with FGR beyond SoC

Orientation discordant fluorescence status

Orientation-level diagnostic performance

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PD G 506 A + Fluorescence-Guided Resection ArmExperimental Treatment2 Interventions

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.

Group II: Standard of Care ArmPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aminolevulinic Acid Hydrochloride

2017

Completed Early Phase 1

~20

0 / 4Eligibility criteria met

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Who is running the clinical trial?

SBI ALApharma Canada, Inc.Lead Sponsor

Ralph DaCosta, PhDStudy DirectorSBI ALApharma Canada

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

Breast Cancer Research Study Groups: PD G 506 A + Fluorescence-Guided Resection Arm, Standard of Care Arm

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the conditions that Aminolevulinic Acid Hydrochloride is indicated for?

"Aminolevulinic Acid Hydrochloride is commonly used to improve the condition of the scalp. However, it can also be given as a treatment for face and squamous cell carcinoma."

Answered by AI

Are there other precedent medical studies involving Aminolevulinic Acid Hydrochloride?

"Aminolevulinic Acid Hydrochloride was first studied in 2013 at Tel Aviv Sourasky Medical Center. So far, there have been a total of 18,291 completed trials. There are presently 20 live studies, with a large number being performed in Orlando, Florida."

Answered by AI

Has the FDA issued a judgment on Aminolevulinic Acid Hydrochloride?

"There is some efficacy data and multiple rounds of safety data, so we have estimated the safety of Aminolevulinic Acid Hydrochloride to be a 3."

Answered by AI

Are there still any unfilled participant positions in this experiment?

"According to the latest update on clinicaltrials.gov, this study is still enrolling patients. The trial was posted on April 27th, 2021 and was edited on August 29th, 2022. There are 370 total spots open for recruitment across 3 sites."

Answered by AI

What primary endpoint is this research trying to establish?

"This study will last for 2 weeks and focus on the diagnostic performance of the intervention. Additionally, the study will measure secondary outcomes including the percentage of orientations where in vivo and ex vivo fluorescence assessments are discordant, the 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, and the patient-level false positive rate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fluorescence Imaging of Carcinoma During Breast Conserving Surgery

2021. "Fluorescence Imaging of Carcinoma During Breast Conserving Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04815083.

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