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

Stopped early · Phase 2

Conditions studied: Neoplasm, Skull Base Neoplasm

In brief

This study allows head and neck cancer surgeons to specifically visualize cancerous cells apart from normal healthy tissue. 5-aminolevulinic acid (5-ALA) is a safe and effective FDA-approved agent successfully used by neurosurgeons for FGS of different brain tumors is given to the patients preoperatively. Using specific wavelengths of light as well as specialized magnified lenses the surgeons use this technique to assist in tumor resection.

Key facts

Study ID: NCT05101798
Run by: Icahn School of Medicine at Mount Sinai
People needed: 7
Starts: 2021-09-14
Expected to finish: 2022-12-25
Last updated by the study team: 2025-07-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects included in this trial must have had documentation of a new or recurrent head and neck or skull base tumor for which surgical resection is indicated and has been planned. These patients will include those with newly diagnosed or recurrent malignancies.
Age 18-80
Karnofsky score >60%
Subjects must have normal organ and marrow function as defined below:
leukocytes ≥ 3,000/mcL
absolute neutrophil count ≥ 1,500/mcL
platelets ≥ 100,000/mcl
total bilirubin within normal institutional limits
AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
creatinine within normal institutional limits OR Creatinine clearance >60 mL/min/1.73m2 for patients with creatinine levels above institutional normal as defined per institution.
The effects of Gleolan® (5-ALA) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. A pregnancy test will be performed for all women of childbearing ability prior to surgery (see Exclusion Criteria below). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent.
all upper aerodigestive head and neck cancers

You may not qualify if…

Patients with non-resectable tumors or not deemed surgical candidates
History of allergic reactions attributed to compounds of similar chemical/biologic composition to ALA.
Personal or family history of porphyria
Uncontrolled concurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness//social situations that would limit compliance with study requirements
Women who are pregnant or become pregnant will be excluded from the trial as it is unknown if ALA is teratogenic or has abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 5-ALA breastfeeding should be discontinued if the mother is treated with 5-ALA.
Prior history of GI perforation, diverticulitis, and or/peptic ulcer disease

Where it is running

Mount Sinai Union Square — New York, New York, United States
New York Eye and Ear Infirmary of Mount Sinai — New York, New York, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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