Pilot Study on Using 5-Aminolevulinic Acid for Fluorescence-Guided Surgery in Head and Neck Cancers

Sponsor: Icahn School of Medicine at Mount Sinai

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05101798

Provider View

This trial explores a new surgical technique using 5-aminolevulinic acid (5-ALA) to help surgeons see cancer cells more clearly during surgery for head and neck cancers, potentially improving the removal of tumors.

Patient Parameters

Program Overview

This study is testing a new method to help surgeons see cancer cells more clearly during surgery for head and neck cancers. The method uses a special substance called 5-aminolevulinic acid (5-ALA), which is safe and approved by the FDA. Before surgery, patients receive 5-ALA, which makes cancer cells glow under certain lights. This helps surgeons distinguish cancerous tissue from healthy tissue, aiming for a more complete removal of the tumor. The study will determine if this technique can improve outcomes like survival and reduce tumor regrowth. It will involve 23 patients from Mount Sinai Hospital and other associated centers, and is expected to be completed by December 2022.

Description

Surgery is a common treatment for head and neck cancers, but sometimes not all cancerous tissue is removed, which can lead to the cancer coming back. This study is testing a new technique called fluorescence-guided surgery (FGS) to help surgeons see cancer cells more clearly during surgery. Before the operation, patients are given a substance called 5-aminolevulinic acid (5-ALA), which is already used safely in brain surgeries. During the surgery, special lights make the cancer cells glow, helping the surgeon to remove them more completely while avoiding healthy tissue. The goal is to see if this method can improve patient outcomes, such as survival rates and reducing the chance of the cancer returning. The study will include 23 patients from Mount Sinai Hospital and other associated centers, and is expected to finish by December 2022.

Eligibility Criteria

Inclusion Criteria

  • Have a new or returning head and neck or skull base tumor that requires surgery.
  • Be between 18 and 80 years old.
  • Have a Karnofsky score greater than 60%, indicating a certain level of physical ability.
  • Have normal organ and bone marrow function, as shown by specific blood tests:
    • White blood cell count of at least 3,000/mcL
    • Neutrophil count of at least 1,500/mcL
    • Platelet count of at least 100,000/mcL
    • Normal bilirubin levels
    • AST and ALT levels no more than 2.5 times the normal limit
    • Normal creatinine levels or creatinine clearance above 60 mL/min/1.73m2
  • Women and men must agree to use effective birth control during the study. Women will have a pregnancy test before surgery.
  • Be able to understand and sign a consent form.
  • Have cancers of the upper aerodigestive tract in the head and neck.

Exclusion Criteria

  • Tumors that cannot be surgically removed or patients not suitable for surgery.
  • Allergic reactions to similar substances as 5-ALA.
  • Personal or family history of porphyria, a rare blood disorder.
  • Uncontrolled health issues like ongoing infections, heart failure, unstable chest pain, irregular heartbeats, or mental health conditions that affect study participation.
  • Women who are pregnant or become pregnant during the study, as the effects of 5-ALA on pregnancy are unknown. Breastfeeding should be stopped if treated with 5-ALA.
  • History of gastrointestinal issues like perforation, diverticulitis, or peptic ulcers.

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