Fluorescence-Guided Surgery for Head and Neck Cancers

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special technique to help surgeons better see and remove cancerous cells in individuals with head and neck cancers. The treatment uses 5-aminolevulinic acid (5-ALA), which makes cancer cells glow under specific light, aiding doctors in identifying and removing them more accurately. Surgeons have already used this approach successfully in brain tumor surgeries. Suitable candidates for this trial include those with a new or recurring head, neck, or skull base tumor who are scheduled for surgery. The trial aims to improve surgical outcomes by ensuring more precise removal of cancerous tissue. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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 prior data suggests that this technique is safe for fluorescence-guided surgery in head and neck cancers?

Research shows that 5-aminolevulinic acid (5-ALA) helps doctors see cancer cells more clearly during brain surgery and is considered safe and effective. The FDA has approved it for this use, indicating it is generally well-tolerated. Although specific safety data for head and neck cancers is lacking, its approval for brain surgeries suggests it can be safely used in similar procedures.

In past uses, 5-ALA has been administered to patients with various types of cancer without major safety issues, suggesting it could be safe for the current study on head and neck cancers. However, discussing this with a doctor is important to understand its implications personally. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for head and neck cancers?

Researchers are excited about 5-aminolevulinic acid hydrochloride (Gleolan®) for head and neck cancers because it offers a unique approach to surgery. Unlike traditional treatments that rely solely on a surgeon's skill and imaging techniques to remove tumors, Gleolan® uses fluorescence to highlight cancerous tissues, making them glow and easier to see during surgery. This method could improve the accuracy of tumor removal, potentially reducing the chances of leaving behind cancerous cells and minimizing the need for additional surgeries. The active ingredient, 5-aminolevulinic acid, is taken orally and specifically targets tumor cells, offering a targeted approach compared to conventional methods.

What evidence suggests that fluorescence-guided surgery using 5-aminolevulinic acid is effective for head and neck cancers?

Research has shown that 5-aminolevulinic acid (5-ALA), which participants in this trial will receive, helps surgeons see cancer cells in head and neck cancers more clearly. Studies have found that 5-ALA makes cancer cells glow during surgery, allowing doctors to distinguish them from healthy tissue more easily. This improved visibility aids surgeons in removing tumors with greater precision. In some cases, 5-ALA also highlights areas where cancer might have spread, such as nearby nerves or lymph nodes. This technique is already approved and successfully used in brain surgeries, which boosts confidence in its potential for head and neck cancers as well. ^{2 5 6 7 8}

Who Is on the Research Team?

Alfred-Marc Iloreta, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37540051/

5-Aminolevulinic Acid Fluorescence-Guided Surgery in ... 5-ALA induces robust intraoperative fluorescence of HNSCC, capable of demonstrating a positive margin, perineural invasion, and metastatic nodal disease.

2. ctv.veeva.com ctv.veeva.com/study/the-role-of-5-aminolevulinic-acid-fluorescence-guided-surgery-in-head-and-neck-cancers-a-pilot-tria

The Role of 5-Aminolevulinic Acid Fluorescence-Guided ... This study allows head and neck cancer surgeons to specifically visualize cancerous cells apart from normal healthy tissue. 5-aminolevulinic ...

3. trialx.com trialx.com/clinical-trials/listings/268461/the-role-of-5-aminolevulinic-acid-fluorescence-guided-surgery-in-head-and-neck-cancers-a-pilot-trial/

The Role of 5-Aminolevulinic Acid Fluorescence-Guided ... Overview. This study allows head and neck cancer surgeons to specifically visualize cancerous cells apart from normal healthy tissue.

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-00869

5-Aminolevulinic Acid Fluorescence-Guided Surgery in ... This phase II trial tests how well 5-aminolevulinic acid fluorescence-guided surgery works in diagnosing patients with head or neck cancers that has not ...

5. withpower.com withpower.com/trial/fluorescence-guided-surgery-for-head-and-neck-cancers-d9b1e

Fluorescence-Guided Surgery 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 ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/aminolevulinic-acid-oral-route/description/drg-20406327

Aminolevulinic acid (oral route) - Side effects & uses Aminolevulinic acid is used to help your doctor see an image of a malignant (cancer) ... Safety and efficacy have not been established.

7. gleolan.com gleolan.com/hcp

Health Care Professional Gleolan (aminolevulinic acid HCl) is the first and only FDA-approved optical imaging agent for use during fluorescence-guided surgery (FGS) in patients with ...

8. clinicaltrials.eu clinicaltrials.eu/inn/aminolevulinic-acid-hydrochloride/

Aminolevulinic Acid Hydrochloride Clinical trials are exploring its use in brain tumors, ovarian cancer, skin cancers, and head and neck cancers to improve surgical outcomes and patient survival ...