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Photosensitizer
Fluorescence-Guided Surgery for Head and Neck Cancers
Phase 2
Recruiting
Led By Alfred-Marc Iloreta, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of surgery, up to 24 hours
Awards & highlights
Study Summary
This trial allows surgeons to see cancer cells using 5-aminolevulinic acid and specific wavelengths of light, which may help resection of tumors.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the side effects of 5-ALA in this context aren't detailed here, common ones may include sensitivity to light where the drug was applied. Since it's used preoperatively just for visualization purposes during surgery, systemic side effects might be minimal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of surgery, up to 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of surgery, up to 24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PPIX tissue fluorescence
Trial Design
1Treatment groups
Experimental Treatment
Group I: 5-aminolevulinic acid hydrochloride (Gleolan®)Experimental Treatment1 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).
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
871 Previous Clinical Trials
527,240 Total Patients Enrolled
NX Development CorpIndustry Sponsor
3 Previous Clinical Trials
318 Total Patients Enrolled
Alfred-Marc Iloreta, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
199 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to perform daily activities without significant limitations.You have had allergic reactions to substances similar to ALA in the past.You or someone in your family has a history of porphyria, a rare genetic disorder.People with any type of head and neck cancer.You have had a previous problem with a hole in your stomach or intestines, or you have had diverticulitis or stomach ulcers in the past.
Research Study Groups:
This trial has the following groups:- Group 1: 5-aminolevulinic acid hydrochloride (Gleolan®)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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