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Fluorescence-Guided Surgery for Head and Neck Cancers
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.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: 5-aminolevulinic acid hydrochloride (Gleolan®)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What are the implications of 5-Aminolevulinic acid Hydrochloride?
"5-Aminolevulinic acid Hydrochloride can target scalp structure, carcinoma, and squamous cell carcinoma."
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."
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."
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."
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."
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."
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."
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