Fluorescent Nerve Imaging with Illuminare-1 for Prostate Cancer

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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests Illuminare-1, a substance that makes nerves glow, in prostate cancer surgeries. It aims to find a safe dose that helps surgeons see and avoid damaging nerves. The study will compare surgeries with and without this glowing guidance.

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 data supports the idea that Fluorescent Nerve Imaging with Illuminare-1 for Prostate Cancer is an effective treatment?

The available research shows that using fluorescent imaging techniques, like those with Illuminare-1, can improve the visualization of tumor margins during prostate cancer surgery. This helps surgeons remove more of the cancerous tissue, which can reduce the chances of the cancer coming back. One study highlighted that a similar approach using a targeted photodynamic agent allowed for better tumor detection and removal compared to traditional methods. This method also helped identify cancer cells in lymph nodes, which is crucial for effective treatment. Overall, these findings suggest that fluorescent imaging can enhance surgical outcomes by making it easier to see and remove cancerous tissues. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Illuminare-1 for prostate cancer?

Research shows that photodynamic therapy (PDT), which uses light-sensitive drugs to kill cancer cells, can improve surgery outcomes by helping doctors see and remove more cancer tissue. This approach has been shown to reduce tumor recurrence and improve survival in prostate cancer, suggesting that similar treatments like Illuminare-1 could be effective. ^{1 2 3 4 5}

What safety data exists for Fluorescent Nerve Imaging with Illuminare-1 for Prostate Cancer?

The provided research does not directly address the safety data for Illuminare-1 or its related names. However, it discusses the use of photodynamic therapy (PDT) and photodynamic diagnosis (PDD) in prostate and other cancers. These studies highlight the potential benefits of PDT and PDD in improving tumor visualization and reducing recurrence, but specific safety data for Illuminare-1 is not mentioned. Further research specifically on Illuminare-1 would be needed to determine its safety profile. ^{1 6 7 8 9}

Is fluorescent nerve imaging with Illuminare-1 safe for humans?

The research does not provide specific safety data for Illuminare-1 or related technologies like D-Light C PDD in humans, but photodynamic therapy (PDT) has been studied in prostate cancer and other conditions, showing potential for improved tumor visualization and reduced recurrence with careful dosimetry to minimize damage to surrounding tissues. ^{1 6 7 8 9}

Is the drug Illuminare-1 a promising treatment for prostate cancer?

Yes, Illuminare-1 is a promising drug for prostate cancer because it helps doctors see nerves clearly during surgery, reducing the risk of nerve damage and improving patient outcomes. ^{10 11 12 13 14}

How does the drug Illuminare-1 differ from other treatments for prostate cancer?

Illuminare-1 is unique because it uses a fluorescent dye to help surgeons see nerves more clearly during prostate cancer surgery, reducing the risk of nerve damage. This approach is different from traditional methods as it provides real-time visualization of nerves, which is not possible with standard imaging techniques. ^{10 11 12 13 14}

Research Team

Timothy Donahue, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Photodynamic Therapy Is an Effective Adjuvant Therapy for Image-Guided Surgery in Prostate Cancer. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Performance of 5-aminolevulinic-acid-based photodynamic diagnosis for radical prostatectomy. [2018]

3. United States 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. [2023]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Rationale for development of new domestic appliances theranostic apparatus for photodynamic therapy and fluorescent diagnostics in oncology]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Near-infrared Intraoperative Molecular Imaging Can Identify Metastatic Lymph Nodes in Prostate Cancer. [2018]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Photodynamic therapy of prostatic adenoma]. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Staging laparoscopy using ALA-mediated photodynamic diagnosis improves the detection of peritoneal metastases in advanced gastric cancer. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Laser dosimetry studies in the prostate. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Online dosimetry for temoporfin-mediated interstitial photodynamic therapy using the canine prostate as model. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Nerve Visualization Using Phenoxazine-Based Near-Infrared Fluorophores to Guide Prostatectomy. [2023]

11. Australia pubmed.ncbi.nlm.nih.gov

Direct Administration of Nerve-Specific Contrast to Improve Nerve Sparing Radical Prostatectomy. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Compact Fluorescence and White Light Imaging System for Intraoperative Visualization of Nerves. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Fluorescence time-resolved imaging system embedded in an ultrasound prostate probe. [2021]

14. Germany pubmed.ncbi.nlm.nih.gov

Clinically translatable formulation strategies for systemic administration of nerve-specific probes. [2023]