Fluorescence Imaging for Breast Cancer

No longer recruiting at 7 trial locations

Overseen By Jagapreetha Visweswaran

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: SBI ALApharma Canada, Inc.

Must not be taking: Phototoxic substances

Disqualifiers: Stage 4 cancer, Porphyria, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help surgeons see breast cancer more clearly during surgery. The treatment uses PD G 506 A, a fluorescent imaging agent, to illuminate cancer cells, making them easier to remove and reducing the need for additional surgeries. It aims to enhance breast-conserving surgery by removing cancer while preserving as much healthy breast tissue as possible. Women with confirmed primary breast cancer who are scheduled for a lumpectomy might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use certain phototoxic substances like St. John's wort or certain antibiotics during the perioperative period (around the time of surgery). It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research shows that PD G 506 A, the treatment used in the trial, is generally well-tolerated. Previous studies found that patients who took PD G 506 A did not experience severe side effects. Some common but mild side effects, such as nausea or temporary sensitivity to light, were reported. These side effects are manageable and usually resolve on their own.

Importantly, the treatment is being tested in a late-stage trial, indicating that earlier studies found it safe enough to continue testing. Additionally, PD G 506 A is similar to other treatments already approved by the FDA for different cancers, which supports its safety.

Overall, the treatment has a good safety record, with no serious side effects commonly reported. It is important to consult a healthcare professional about any concerns before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Researchers are excited about the treatment PD G 506 A in breast cancer care because it introduces fluorescence-guided resection, a novel technique that could enhance surgical precision. Unlike standard treatments that rely solely on visual and tactile cues, this method uses a fluorescent marker to highlight cancerous tissues, potentially reducing the chances of leaving behind tumor cells. This innovative approach could lead to more successful surgeries and better outcomes for patients.

What evidence suggests that PD G 506 A is effective for breast cancer?

In this trial, participants in the PD G 506 A + Fluorescence-Guided Resection Arm will receive PD G 506 A. Studies have shown that this treatment can help doctors see cancer cells during breast-conserving surgery. The treatment transforms into a glowing substance in the body, causing cancer cells to light up. Earlier research demonstrated that this glow helped surgeons find and remove any remaining cancerous tissue that might otherwise be missed, potentially reducing the need for follow-up surgeries. The glowing effect increases the likelihood of removing all cancer in one procedure, enhancing the surgery's effectiveness. Meanwhile, participants in the Standard of Care Arm will receive a placebo and undergo standard procedures without fluorescence-guided resection. ^{1 2 3 4 6}

Who Is on the Research Team?

Ralph DaCosta, PhD

Principal Investigator

SBI ALApharma Canada

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for surgery to remove a breast tumor.

Women of child-bearing potential must agree to use adequate contraception starting the day entering the study

I am a woman aged 18 or older.

Exclusion Criteria

I have had surgery on the breast affected by cancer.

My surgery includes a real-time biopsy analysis.

I have recovered from side effects of any trial drugs or tests taken over a month ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Open-label training phase to optimize workflow for fluorescence imaging during breast conserving surgery

2 weeks

Treatment

Participants receive PD G 506 A or placebo followed by standard of care breast conserving surgery with fluorescence imaging

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including re-operation rates and patient satisfaction

12 months

What Are the Treatments Tested in This Trial?

Interventions

• PD G 506 A

Trial Overview 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.

How Is the Trial Designed?

Group I: PD G 506 A + Fluorescence-Guided Resection Arm Experimental Treatment 2 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 Arm Placebo Group 1 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.

Who Is Running the Clinical Trial?

SBI ALApharma Canada, Inc.

Lead Sponsor

Trials

1

Recruited

370+

Published Research Related to This Trial

A new noninvasive imaging technique using a near-infrared (NIR) dye-labeled anti-PD-L1 monoclonal antibody effectively monitors PD-L1 expression in colorectal cancer (CRC) models, showing the highest fluorescence in tumors with high PD-L1 levels.

This imaging method is safe and can help tailor personalized immunotherapy strategies by providing real-time insights into PD-L1 expression in tumors, which is crucial for predicting treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near-infrared fluorescence-labeled anti-PD-L1-mAb for tumor imaging in human colorectal cancer xenografted mice. Zhang, M., Jiang, H., Zhang, R., et al.[2021]

In vivo time-domain fluorescence imaging can effectively quantify PD-L1 expression in tumors, providing a more dynamic and comprehensive assessment compared to traditional immunohistochemistry methods, which only offer static snapshots.

This imaging technique, utilizing a longer fluorescence lifetime of a PD-L1 specific antibody, allows for accurate measurement of PD-L1 heterogeneity in both superficial and deep tumors, potentially enhancing the selection process for cancer immunotherapy across multiple subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo quantification of programmed death-ligand-1 expression heterogeneity in tumors using fluorescence lifetime imaging. Pal, R., K, M., Matsui, A., et al.[2023]

The PD-1-IRDye800CW probe effectively targets breast tumors for imaging during surgery, allowing for better identification of microscopic tumor residuals, which can help reduce the risk of positive surgical margins.

Combining PD-1-IRDye800CW-guided surgery with PD-1 monoclonal antibody immunotherapy significantly inhibits tumor regrowth and metastases, leading to improved survival rates in a mouse model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved resection and prolonged overall survival with PD-1-IRDye800CW fluorescence probe-guided surgery and PD-1 adjuvant immunotherapy in 4T1 mouse model. Du, Y., Sun, T., Liang, X., et al.[2018]

Photoimmunotherapy (PIT) effectively targets and reduces tumor volume in gastric cancer models, showing significant anti-tumor effects with reductions in tumor size and GFP fluorescence intensity after treatment with the trastuzumab-IR700 conjugate and near-infrared light.

The cytotoxic effects of PIT are dependent on the light dose, leading to necrotic cell rupture, which can be monitored by a decrease in GFP fluorescence, making it a useful biomarker for assessing treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoimmunotherapy of gastric cancer peritoneal carcinomatosis in a mouse model. Sato, K., Choyke, PL., Kobayashi, H.[2022]

The study demonstrates that HerGa, a targeted gallium corrole, is effective for both detecting and delineating HER2+ tumors in vivo using advanced multimode optical imaging techniques.

Different imaging modes, particularly fluorescence lifetime imaging, allow for clear differentiation between tumor and non-tumor regions, enhancing the accuracy of tumor localization and potentially improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimode Optical Imaging for Translational Chemotherapy: In Vivo Tumor Detection and Delineation by Targeted Gallium Corroles. Hwang, JY., Gross, Z., Gray, HB., et al.[2020]

The newly developed probe anti-PD-L1-BGP6, which uses the bright NIR-II fluorophore IR-BGP6, allows for efficient noninvasive imaging of PD-L1 expression in tumors, achieving a high tumor-to-normal tissue signal ratio of approximately 9.5.

IR-BGP6 demonstrates rapid renal excretion (about 91% within 10 hours), minimizing tissue accumulation and enhancing the clarity of imaging, making it a promising tool for studying cancer immunotherapy mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Bright NIR-II Fluorophore with Fast Renal Excretion and Its Application in Molecular Imaging of Immune Checkpoint PD-L1. Wan, H., Ma, H., Zhu, S., et al.[2023]

The 99mTc-PD-L1 affibody molecular probe effectively targets PD-L1-positive tumors, demonstrating a high labeling yield of 95.95% and good stability, making it a promising tool for in vivo imaging of PD-L1 expression in cancer.

This probe shows rapid uptake in PD-L1-positive tumors with minimal retention in PD-L1-negative tumors, indicating its specificity, and it clears quickly from the bloodstream without significant toxic side effects, suggesting a safe profile for potential clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel small 99mTc-labeled affibody molecular probe for PD-L1 receptor imaging. Liang, Z., Hu, X., Hu, H., et al.[2022]

The development of green fluorescent protein (GFP) imaging in mice allows for real-time visualization of tumor progression and metastasis, providing a powerful tool for studying cancer dynamics and drug responses.

This technology enables the imaging of various cancer types, including colon, prostate, and breast cancers, and allows researchers to visualize single cancer cells and assess angiogenesis in vivo, enhancing our understanding of tumor biology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Green fluorescent protein imaging of tumour growth, metastasis, and angiogenesis in mouse models. Hoffman, R.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04815083?tab=results

Study Results | NCT04815083 | Fluorescence Imaging of ... 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 ...

2. cancernetwork.com cancernetwork.com/view/pivotal-phase-3-randomized-controlled-trial-evaluating-the-safety-and-efficacy-of-aminolevulinic-acid-for-the-real-time-visualization-of-cancer-through-fluorescent-imaging-during-breast-conserving-surgery

21 TiP Pivotal Phase 3, Randomized Controlled Trial ... Patients will be randomized to receive PD G 506 A or placebo orally 3 hours prior to anesthesia. All patients will undergo standard-of-care (SOC) ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-05679

Fluorescence Imaging of Carcinoma During Breast ... 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 ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/83/NCT04815083/Prot_SAP_001.pdf

SBI ALApharma Canada Inc. ... PD G 506 A-induced fluorescence for the real-time visualization of malignant tissue(s) during SoC lumpectomy for breast cancer. Part. A is an ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35544130/

Clinical Impact of Intraoperative Margin Assessment in Breast ... Objective: To collect safety and initial efficacy data on the novel pegulicianine fluorescence-guided system (pFGS) when used to identify ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34253233/

Intraoperative fluorescence imaging with aminolevulinic ... Intraoperative fluorescence imaging with aminolevulinic acid detects grossly occult breast cancer: a phase II randomized controlled trial.