7
Participants
Start Date
September 14, 2021
Primary Completion Date
December 25, 2022
Study Completion Date
December 25, 2022
5-Aminolevulinic acid Hydrochloride
The closure consists of colorless glass vial (Type II, Ph Eur) and bromobutyl-rubber stopper ø 20 mm (Type I, Ph Eur) and flip cap. The powder for oral solution is intended for single (partial) use. To prepare the ready-to-use solution the content of one vial is dissolved in 50 ml of water or apple juice. The concentration of the reconstituted solution is 3%. Gleolan® is administered orally to patients prior to tumor removal by surgery (20 mg/kg BW). The reconstituted solution may be prepared up to 24 hours prior to use if protected from light. It should be given 3 hours (range 3-5 hours) prior to planned induction of anesthesia for surgery, although its effect is present for up to 8-12 hours. This step is critical for an optimal visualization of tumor tissue due to pharmacokinetic properties of Gleolan®.
Mount Sinai Union Square, New York
New York Eye and Ear Infirmary of Mount Sinai, New York
Icahn School of Medicine at Mount Sinai, New York
Collaborators (1)
NX Development Corp
INDUSTRY
Icahn School of Medicine at Mount Sinai
OTHER