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

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Oct 28, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a special substance called 5-aminolevulinic acid (5-ALA) to help surgeons better see and remove cancerous cells during surgery for head and neck cancers. By taking 5-ALA before surgery, the cancer cells will glow under specific lights, making it easier for doctors to distinguish them from healthy tissue. This technique is already used by neurosurgeons for brain tumors and could improve outcomes for patients with tumors in the head and neck area.

To participate in the trial, patients must be between 18 and 80 years old and have a new or recurring head and neck tumor that needs to be surgically removed. They should also be in good overall health, with normal blood and organ function. Participants will receive the 5-ALA before their surgery, and they will need to sign a consent form to show they understand the study. It’s important to note that pregnant women or those who may become pregnant cannot join the trial due to unknown risks. Overall, this study aims to provide valuable information on how 5-ALA can enhance cancer surgery and improve patient care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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