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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 weeks
Treatment ~ Varies
Follow Up ~through completion of surgery, up to 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of surgery, up to 24 hours for reporting.

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).

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,453 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

Media Library

5-Aminolevulinic acid Hydrochloride (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT05101798 — Phase 2
Tumors Research Study Groups: 5-aminolevulinic acid hydrochloride (Gleolan®)
Tumors Clinical Trial 2023: 5-Aminolevulinic acid Hydrochloride Highlights & Side Effects. Trial Name: NCT05101798 — Phase 2
5-Aminolevulinic acid Hydrochloride (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05101798 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the implications of 5-Aminolevulinic acid Hydrochloride?

"5-Aminolevulinic acid Hydrochloride can target scalp structure, carcinoma, and squamous cell carcinoma."

Answered by AI

Is 5-Aminolevulinic acid Hydrochloride a new medication?

"Currently, there are 20 clinical trials studying the effects of 5-Aminolevulinic acid Hydrochloride. 2 of these trials have reached Phase 3. The majority of these clinical trials originate from Lebanon and New hampshire; though, 59 different locations across the world are running studies for 5-Aminolevulinic acid Hydrochloride."

Answered by AI

Are they currently looking for more participants in this research project?

"The clinicaltrials.gov website provides evidence that this study is enrolling patients at the moment. The listing for this trial was first published on September 14th 2021 and was updated as recently as October 28th, 2021. There are 23 participants needed between 3 sites in total."

Answered by AI

Are elderly patients being sought for this trial?

"The age range that is eligible for this particular study starts at 18 years old and goes up to 80 years old."

Answered by AI

How do I go about joining this clinical trial?

"Up to 23 people with skull base neoplasms who meet the age criteria of 18-80 years old may be recruited for this trial. Most notably, candidates are required to have a Karnofsky score >60%. To be eligible, potential subjects must also have documentation of a new or recurrent head and neck or skull base tumor which will require surgical resection as part of their planned treatment."

Answered by AI

What is the success rate of 5-Aminolevulinic acid Hydrochloride?

"5-Aminolevulinic acid Hydrochloride is a Phase 2 medication, so while there is some evidence of its safety, none exists for its efficacy. Our team at Power gave it a score of 2."

Answered by AI

How many people are signing up to participate in this research?

"That is correct. The information available on clinicaltrials.gov demonstrates that this study is still recruiting patients. This trial was originally posted on September 14th, 2021 and was updated as recently as October 28th, 2021. They are currently looking for 23 individuals across 3 different sites."

Answered by AI
~6 spots leftby Mar 2025