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Fluorescent Dye
ALM-488 for Nerve Visualization during Head and Neck Surgery
Phase 3
Recruiting
Led By Ryan Orosco, MD
Research Sponsored by Alume Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The study participant's primary surgical treatment is parotidectomy or thyroidectomy (unilateral or bilateral) or cervical neck dissection
Must be planning to undergo surgery in the Head and Neck
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during surgery
Awards & highlights
Study Summary
This trial will test whether the drug ALM-488 is effective in treating patients with a certain medical condition. The trial will be conducted at multiple centers and will compare the results of patients who receive ALM-488 to those who do not.
Who is the study for?
This trial is for individuals at least 16 years old who are scheduled for head and neck surgery, specifically parotidectomy, thyroidectomy, or cervical neck dissection. Participants must be able to follow the study procedures and provide consent. They should use contraception during the study if sexually active. Exclusions include allergy to fluorescein or ALM-488, prior radiation/surgery in the area, uncontrolled heart rhythm issues, severe kidney impairment, unresolved high-grade toxicity from cancer therapy, severe allergies or conditions affecting study participation.Check my eligibility
What is being tested?
The trial is testing ALM-488's ability to help surgeons see nerves more clearly during head and neck surgeries by comparing two methods: using a combination of white light reflectance with fluorescence overlay versus standard white light reflectance alone.See study design
What are the potential side effects?
Potential side effects of ALM-488 may include allergic reactions due to sensitivity to the drug or its components. Since it involves intra-operative visualization techniques, risks associated with surgical procedures may also apply.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My main surgery was on my salivary gland, thyroid, or neck.
Select...
I am scheduled for surgery in the head or neck area.
Select...
I am at least 16 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Contrast Enhancement
Length Measurement
Trial Design
4Treatment groups
Experimental Treatment
Group I: ALM-488-002b WLR with FL OverlayExperimental Treatment2 Interventions
Patients without a preoperative diagnosis of malignancy will be assigned to study ALM-488-002b. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR with FL Overlay.
Group II: ALM-488-002b WLR onlyExperimental Treatment2 Interventions
Patients without a preoperative diagnosis of malignancy will be assigned to study ALM-488-002b. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR only.
Group III: ALM-488-002a WLR with FL OverlayExperimental Treatment2 Interventions
Patients with a preoperative diagnosis of malignancy will be assigned to study ALM-488-002a. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR with FL Overlay.
Group IV: ALM-488-002a WLR onlyExperimental Treatment2 Interventions
Patients with a preoperative diagnosis of malignancy will be assigned to study ALM-488-002a. All patients will receive ALM-488 infusion. Intraoperative nerve visualization will be performed using WLR only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALM-488
2020
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
ErgomedIndustry Sponsor
10 Previous Clinical Trials
3,031 Total Patients Enrolled
Alume Biosciences, Inc.Lead Sponsor
2 Previous Clinical Trials
121 Total Patients Enrolled
1 Trials studying Surgery
41 Patients Enrolled for Surgery
Ryan Orosco, MDPrincipal InvestigatorUniversity of New Mexico
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery or radiation on the area to be operated on.I have side effects from cancer treatment that are not severe, except for hair loss or mild nerve pain.I can become pregnant and agree to regular pregnancy tests during the study.My main surgery was on my salivary gland, thyroid, or neck.I haven't had severe heart failure, a heart attack, or stroke in the last 6 months.I agree to use effective birth control during and for 30 days after the study.My liver tests are slightly above normal.I am allergic to ALM-488 or its ingredients.I am scheduled for surgery in the head or neck area.My heart rhythm is irregular and not managed by medication.My kidney function is reduced with a GFR less than 60 mL/min.I am at least 16 years old.
Research Study Groups:
This trial has the following groups:- Group 1: ALM-488-002a WLR only
- Group 2: ALM-488-002a WLR with FL Overlay
- Group 3: ALM-488-002b WLR only
- Group 4: ALM-488-002b WLR with FL Overlay
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being given the opportunity to participate in this research project?
"That is correct, this research project is currently open to new participants. The study was first announced on April 29th, 2022 and received some updates on May 19th of the same year. A total of 200 people will be accepted at 2 locations."
Answered by AI
Do we have room for new participants in this clinical trial?
"Yes, according to the latest information on clinicaltrials.gov, this trial is currently recruiting patients. The original posting was on April 29th, 2022, and it was last updated on May 19th, 2022. The study is looking for 200 participants at 2 locations."
Answered by AI
What is the FDA's latest stance on ALM-488?
"ALM-488 has received a safety score of 3. This is due to the fact that this is a Phase 3 trial, meaning there is some data supporting efficacy and multiple rounds of data supporting safety."
Answered by AI
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