The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial

PHASE2TerminatedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

September 14, 2021

Primary Completion Date

December 25, 2022

Study Completion Date

December 25, 2022

Conditions
NeoplasmSkull Base Neoplasm
Interventions
DRUG

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®.

Trial Locations (3)

10003

Mount Sinai Union Square, New York

New York Eye and Ear Infirmary of Mount Sinai, New York

10029

Icahn School of Medicine at Mount Sinai, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

NX Development Corp

INDUSTRY

lead

Icahn School of Medicine at Mount Sinai

OTHER

NCT05101798 - The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial | Biotech Hunter | Biotech Hunter