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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

Must not have

Various surgical procedures performed on the involved breast

Currently on (neo)adjuvant therapy to treat another cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on the breast affected by cancer.

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I am currently receiving treatment to prevent my cancer from returning.

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I am not using any other medications that increase sensitivity to light.

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My breast condition has not spread beyond the milk ducts or lobules.

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My cancer is at stage 4 and has spread to other parts of my body.

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I am getting or planning to get initial therapy for my breast cancer.

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I have a collagen vascular disease.

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I am unable to give consent by myself.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diagnostic performance (Sensitivity)

Diagnostic performance (Specificity)

Positive margin conversion rate

Secondary study objectives

Amount of tissue removed with FGR beyond SoC

Orientation discordant fluorescence status

Orientation-level diagnostic performance

+13 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 12Eligibility criteria met