Fluorescence-Guided Surgery for Head and Neck Cancers

Recruiting at 2 trial locations

Overseen By Chanel Rojas

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Non-resectable tumors, Porphyria, Pregnancy, others

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

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

Compensation: Varies

Number of Visits: 2

7 Participants Needed

Trial Summary

What is the purpose of this trial?

This study allows head and neck cancer surgeons to specifically visualize cancerous cells apart from normal healthy tissue. 5-aminolevulinic acid (5-ALA) is a safe and effective FDA-approved agent successfully used by neurosurgeons for FGS of different brain tumors is given to the patients preoperatively. Using specific wavelengths of light as well as specialized magnified lenses the surgeons use this technique to assist in tumor resection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment 5-Aminolevulinic acid Hydrochloride for fluorescence-guided surgery in head and neck cancers?

Research shows that using 5-aminolevulinic acid (5-ALA) in fluorescence-guided surgery helps doctors see the difference between cancerous and normal tissue more clearly, which can lead to more complete removal of tumors and potentially better outcomes for patients with head and neck cancers. ^{1 2 3 4 5}

Is 5-aminolevulinic acid safe for use in humans?

Studies show that 5-aminolevulinic acid (5-ALA) is generally safe for use in humans, with no side effects observed in trials for head and neck cancers. After administration, the body returns to normal levels of the substance within 12 hours, minimizing any risk of skin sensitivity to light. ^{1 3 6 7 8}

How does the drug 5-Aminolevulinic acid Hydrochloride differ from other treatments for head and neck cancers?

5-Aminolevulinic acid Hydrochloride is unique because it is used in fluorescence-guided surgery to help surgeons see and remove cancerous tissue more accurately. It works by converting into a substance that glows under special light, highlighting cancer cells and making it easier to distinguish them from healthy tissue during surgery. ^{1 3 8 9 10}

Research Team

Alfred-Marc Iloreta, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for adults aged 18-80 with new or recurrent head and neck cancers, including skull base tumors, who are scheduled for surgery. Participants must have normal organ function, not be pregnant or breastfeeding, agree to use contraception, and have no history of allergic reactions to similar compounds or certain medical conditions like porphyria.

Inclusion Criteria

Subjects must have normal organ and marrow function as defined below:

You are able to perform daily activities without significant limitations.

Subjects included in this trial must have had documentation of a new or recurrent head and neck or skull base tumor for which surgical resection is indicated and has been planned. These patients will include those with newly diagnosed or recurrent malignancies.

Exclusion Criteria

You have had allergic reactions to substances similar to ALA in the past.

Women who are pregnant or become pregnant will be excluded from the trial as it is unknown if ALA is teratogenic or has abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 5-ALA breastfeeding should be discontinued if the mother is treated with 5-ALA.

Patients with non-resectable tumors or not deemed surgical candidates

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Participants receive oral Gleolan® prior to tumor removal surgery

1 day

1 visit (in-person)

Surgery

Fluorescence-guided surgery is performed to assist in tumor resection

Up to 24 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

Treatment Details

Interventions

• 5-Aminolevulinic acid Hydrochloride

Trial Overview Surgeons are testing a technique using 5-Aminolevulinic Acid (5-ALA) to better distinguish cancer cells from healthy tissue during surgery. This FDA-approved agent helps visualize the tumor more clearly when exposed to specific light wavelengths.

Participant Groups

Group I: 5-aminolevulinic acid hydrochloride (Gleolan®) Experimental Treatment 1 Intervention

Gleolan® is available in colorless glass vials containing 1.5 g 5-aminolevulinic acid hydrochloride (Gleolan®) Gleolan® is administered orally to patients prior to tumor removal by surgery (20 mg/kg BW).

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

NX Development Corp

Industry Sponsor

Trials

4

Recruited

330+

References

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

5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Squamous Cell Carcinoma. [2023]

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

Determination of Tumor Margins with Surgical Specimen Mapping Using Near-Infrared Fluorescence. [2019]

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

Fluorescence imaging and spectroscopy of 5-aminolevulinic acid induced protoporphyrin IX for the detection of neoplastic lesions in the oral cavity. [2019]

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

Intraoperative Fluorescence-Guided Surgery in Head and Neck Squamous Cell Carcinoma. [2023]

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

Current and Future Applications of Fluorescence-Guided Surgery in Head and Neck Cancer. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Sublingual administration of 5-aminolevulinic acid for laser-induced photodiagnostics and photodynamic therapy of oral cavity and larynx cancers. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

[Fluorescence staining of oral and laryngeal cancer after application of 5-aminolevulinic acid]. [2016]

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

Excretion measurement of porphyrins and their precursors after topical administration of 5-aminolaevulinic acid for fluorescence endoscopy in head and neck cancer. [2013]

9. Ireland pubmed.ncbi.nlm.nih.gov

Fluorescence diagnostics and kinetic studies in the head and neck region utilizing low-dose delta-aminolevulinic acid sensitization. [2019]

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

Role of near-infrared fluorescence imaging in head and neck cancer surgery: from animal models to humans. [2021]