Fluorescent Nerve Imaging with Illuminare-1 for Prostate Cancer

No longer recruiting at 5 trial locations

Overseen By Vincent Laudone, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Neurotoxic drugs, Phototoxic drugs

Disqualifiers: Pelvic surgery, Nervous system disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of a new imaging drug, Illuminare-1, during prostate cancer surgery to help doctors better visualize nerve structures. The researchers seek to determine the dose that illuminates the nerves without causing significant side effects. The trial will also explore how the body processes the drug. Men scheduled for specific prostate surgery who haven't undergone previous pelvic surgery or radiation might be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how Illuminare-1 works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop all current medications. However, you must avoid phototoxic drugs like St. John's wort and certain antibiotics. If you can safely stop these, you must do so for 5 half-lives before and 48 hours after taking Illuminare-1.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially if they are phototoxic (make your skin sensitive to light) like St. John's wort or certain antibiotics. If it's safe, you'll need to stop these medications for a period before and after receiving Illuminare-1.

What prior data suggests that Illuminare-1 is safe for use in prostate cancer surgery?

Research shows that Illuminare-1 is being tested for safety in patients undergoing prostate cancer surgery. As this is the first use of Illuminare-1 in humans, specific safety data is not yet available. However, this early-stage study (Phase 1) is designed to closely monitor side effects and ensure safety. This phase typically aims to identify the safest dose with the fewest side effects. Although direct safety data for Illuminare-1 is not yet available, its Fast Track status from the FDA indicates promise in earlier lab studies. Participants in this trial will help determine how well people tolerate Illuminare-1 at different doses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Illuminare-1 is unique because it uses fluorescent nerve imaging to enhance the visualization of nerves during prostate cancer surgery. This approach is different from standard treatments which primarily rely on direct visualization and traditional imaging techniques. Researchers are excited about Illuminare-1 because it has the potential to improve surgical accuracy, reduce nerve damage, and preserve prostate function, offering a promising advancement in prostate cancer treatment.

What evidence suggests that Illuminare-1 is effective for prostate cancer surgery?

Research has shown that Illuminare-1, a special dye under investigation in this trial, could aid in prostate cancer surgery. This dye adheres to the protective layer around nerves, causing them to glow and helping surgeons avoid damaging them. Early findings suggest it can make nerves glow safely without major side effects. In a study with 38 patients undergoing prostate surgery, the treatment proved safe. The initial results are promising, but further research is needed to confirm if it improves surgical outcomes. ^{1 3 4 6 7}

Who Is on the Research Team?

Timothy Donahue, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent and are scheduled for a specific prostate cancer surgery. It's not for those with prior pelvic procedures, recent investigational drugs use, significant kidney or liver issues, exposure to phototoxic drugs without proper washout period, or nervous system diseases.

Inclusion Criteria

I am scheduled for a specific prostate surgery with lymph node removal.

I am over 18 and can sign a consent form.

Exclusion Criteria

My kidney function is reduced, with a creatinine clearance rate below 60 mL/min.

I do not have a nervous system condition, nor am I taking medications that could harm my nerves.

I can stop taking certain medications that react to light before and after the Illuminare-1 injection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of Illuminare-1 to determine the dose that causes nerve structures to fluoresce with few or mild side effects

up to 45 days

Pharmacokinetics

Tests are conducted to study the absorption, distribution, and elimination of Illuminare-1 in the body

Concurrent with Dose Escalation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Illuminare-1
• Karl Storz D-Light C photodynamic diagnostic (PDD)

Trial Overview The study tests Illuminare-1's safety and optimal dose during prostate cancer surgery. Researchers will see if surgeries guided by Illuminare-1 are better than standard ones and will also examine how the body processes this drug.

How Is the Trial Designed?

Group I: Illuminare-1 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Illuminare Biotechnologies

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

The study demonstrated that a PSMA-targeted photodynamic therapy (PDT) agent, PSMA-1-Pc413, significantly improves tumor visualization during surgery, allowing for more complete resection of prostate tumors compared to traditional white light surgery.

Using this PDT agent not only enhanced the identification of tumors but also reduced recurrence rates and extended survival in animal models, indicating its potential as a valuable treatment option for prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic Therapy Is an Effective Adjuvant Therapy for Image-Guided Surgery in Prostate Cancer. Wang, X., Ramamurthy, G., Shirke, AA., et al.[2022]

Photodynamic diagnosis (PDD) using oral 5-aminolevulinic acid (ALA) significantly improved the detection rate of peritoneal metastases in advanced gastric cancer, with a detection sensitivity of 72% compared to only 39% with conventional white light.

In a study involving 13 patients, ALA-PDD successfully identified additional metastatic lesions that were not visible under white light, highlighting its potential as a valuable tool for preoperative staging and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staging laparoscopy using ALA-mediated photodynamic diagnosis improves the detection of peritoneal metastases in advanced gastric cancer. Kishi, K., Fujiwara, Y., Yano, M., et al.[2015]

Photodynamic therapy (PDT) shows promise as a treatment for prostate cancer and benign prostatic hyperplasia (BPH), utilizing light and a photosensitizer drug to target tumors effectively.

Effective application of PDT requires real-time optical dosimetry to ensure accurate control of the treated tissue volume, as light penetration is limited and varies between cancerous and normal prostatic tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser dosimetry studies in the prostate. Chen, Q., Hetzel, FW.[2007]

A new library of near-infrared (NIR) phenoxazine-based fluorophores has been developed for intraoperative imaging, specifically designed to identify nerve tissues during prostate surgery.

The lead fluorophore successfully highlighted prostatic nerves in animal models using the da Vinci Surgical System, indicating its potential for clinical use to minimize nerve injury during prostate cancer surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nerve Visualization Using Phenoxazine-Based Near-Infrared Fluorophores to Guide Prostatectomy. Wang, LG., Montaño, AR., Masillati, AM., et al.[2023]

Fluorescent diffuse optical imaging, when combined with ultrasound, can significantly improve the accuracy of locating prostate tumors, achieving a remarkable location accuracy of 0.15 cm in a controlled setting.

This innovative imaging technique could enhance biopsy procedures by allowing for more precise targeting of tumors, potentially leading to earlier detection of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorescence time-resolved imaging system embedded in an ultrasound prostate probe. Laidevant, A., Hervé, L., Debourdeau, M., et al.[2021]

Online light dosimetry with real-time feedback during temoporfin-mediated photodynamic therapy (PDT) in dogs resulted in more precise targeting of the prostate tissue, leading to effective necrosis while minimizing damage to surrounding organs.

The study established a light energy dose-response relationship, identifying a threshold dose of 20 to 30 J/cm2 necessary to induce necrosis in the prostate gland, which is crucial for optimizing treatment protocols in future human applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online dosimetry for temoporfin-mediated interstitial photodynamic therapy using the canine prostate as model. Swartling, J., Höglund, OV., Hansson, K., et al.[2019]

Intraoperative use of 5-aminolevulinic acid (ALA) for photodynamic diagnosis (PDD) during radical prostatectomy showed a sensitivity of 75.0% and specificity of 87.3% in detecting positive surgical margins in prostate cancer patients, indicating its potential effectiveness in improving surgical outcomes.

Out of 52 patients, only one had a confirmed red-fluorescent-positive margin, suggesting that while ALA-PDD is feasible, factors like heat degeneration and the length of positive margins significantly affect its diagnostic performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of 5-aminolevulinic-acid-based photodynamic diagnosis for radical prostatectomy. Fukuhara, H., Inoue, K., Kurabayashi, A., et al.[2018]

The study introduces a new approach to prostate cancer surgery by combining indocyanine green fluorescence imaging with 99m Tc-prostate-specific membrane antigen-targeted radioguidance, enhancing the detection of tumors.

This integration allows for better in-depth detection and real-time visualization of cancerous tissues during surgery, potentially improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time Identification of Nodal Metastases With 99m Tc-Prostate-Specific Membrane Antigen-Based Radioguidance and Indocyanine Green Fluorescence Imaging in Primary Prostate Cancer Surgery-On the Road to Hybrid Image-Guided Surgery. de Barros, HA., van Oosterom, MN., van Leeuwen, FWB., et al.[2023]

Indocyanine green (ICG) effectively accumulates in prostate cancer tissues, as demonstrated in both a mouse model and a pilot study involving 4 human patients, indicating its potential for targeted imaging during surgery.

Near-infrared (NIR) fluorescence imaging using ICG successfully identified lymph node metastases in 3 out of 4 patients during robotic pelvic lymph node dissection, suggesting it could enhance the accuracy of detecting cancerous nodes in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near-infrared Intraoperative Molecular Imaging Can Identify Metastatic Lymph Nodes in Prostate Cancer. Xia, L., Zeh, R., Mizelle, J., et al.[2018]

The development of original theranostic devices that combine photodynamic therapy (PDT) and fluorescent diagnostics (FD) is crucial for improving cancer diagnosis and treatment outcomes.

Effective cancer treatment relies on the precise pairing of photosensitizers with light sources that match their absorption wavelengths, highlighting the need for integrated medical devices in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rationale for development of new domestic appliances theranostic apparatus for photodynamic therapy and fluorescent diagnostics in oncology]. Gafton, GL., Senchik, KY., Belyaev, AM., et al.[2019]

Photodynamic therapy (PDT) using the photosensitizer photoditasine has been successfully applied to treat prostatic adenoma, showing significant regression of irritative and obstructive symptoms in patients.

This technique is particularly beneficial for older patients or those with health issues, as it reduces hospital stays and maintains sexual function, allowing treatment in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Photodynamic therapy of prostatic adenoma]. Iagudaev, DM., Sorokatyĭ, AE., Martov, AG., et al.[2016]

A new direct administration method for nerve-specific fluorophores significantly enhances the visibility of vital nerve structures during nerve-sparing radical prostatectomy, providing a brighter fluorescent signal compared to systemic administration.

This method requires a much lower dose of the fluorophore, which is safe and falls within the microdosing range, making it a promising approach for improving surgical outcomes and preserving nerve function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct Administration of Nerve-Specific Contrast to Improve Nerve Sparing Radical Prostatectomy. Barth, CW., Gibbs, SL.[2018]

The development of fluorescence image guided surgery (FIGS) with a custom nerve-labeling fluorophore (GE3082) aims to reduce nerve damage during surgeries, addressing a significant clinical need.

The FIGS system, which includes advanced imaging hardware and a specific laser and camera setup, was tested in rats, showing potential for improved intraoperative visualization of critical nerve structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compact Fluorescence and White Light Imaging System for Intraoperative Visualization of Nerves. Gray, D., Kim, E., Cotero, V., et al.[2023]

The novel near-infrared (NIR) nerve-specific fluorophore, LGW01-08, significantly enhances nerve identification during surgery, allowing for the visualization of nerves buried under approximately 3 mm of tissue, which traditional white light imaging cannot achieve.

In laparoscopic swine surgeries using the da Vinci surgical robot, LGW01-08 demonstrated a favorable safety profile with a 10x difference between toxicity and effective imaging doses, supporting its potential for clinical use in fluorescence guided surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically translatable formulation strategies for systemic administration of nerve-specific probes. Barth, CW., Shah, VM., Wang, LG., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04983862

Fluorescent Imaging of Nerves With Illuminare-1 During ... This study will test the safety of using Illuminare-1 during standard surgery for prostate cancer. The study researchers will test increasing doses of ...

2. merkavaholdings.com merkavaholdings.com/wp-content/uploads/2025/07/Results-of-Illuminare-1-Phase-1-Study-JAMA-Surgery_Dr-Gold-et-al_2025_oi_250033_1750446833.41258.pdf

Rizedisben in Minimally Invasive Surgery A ... Rizedisben (Illuminare-1; Illuminare Biotechnologies) is a novel small-molecule fluorophore that binds to myelin and fluoresces in the blue ...

3. mskcc.org mskcc.org/news/new-prostate-cancer-surgery-imaging-technique-could-reduce-side-effects

New Imaging Technique Could Reduce Side Effects ... Results from a phase 1 clinical trial reported in JAMA Surgery suggest the nerve-illuminating agent is safe and effective. When given to ...

4. medpagetoday.com medpagetoday.com/hematologyoncology/prostatecancer/116372

Nerve-Illuminating Agent Shows Early Promise for ... A nerve-illuminating agent to minimize surgical risk passed an early test by achieving sustained fluorescence of the obturator nerve without safety concerns.

5. jamanetwork.com jamanetwork.com/journals/jamasurgery/article-abstract/2835766

Rizedisben in Minimally Invasive Surgery In this nonrandomized clinical trial among 38 patients undergoing robotic radical prostatectomy, rizedisben demonstrated an excellent safety profile at each ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11201469/

Preliminary Results from the PRESERVE Trial - PubMed Central This study supports prior findings that IRE prostate ablation with the NanoKnife System can be performed safely. Final results are required to ...

7. nature.com nature.com/articles/s41391-023-00783-y

A multi-center international study to evaluate the safety ... The primary outcome was the recurrence rate of prostate cancer at 1 year. The patients were proposed for prostate biopsy at 1-year post-IRE ...