ALM-488-002a WLR with FL Overlay for Surgery

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Pennsylvania, Philadelphia, PA
Surgery
Intra-operative Visualization using White Light Reflectance (WLR) - Other
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate ALM-488.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: During surgery

During Surgery
Length Measurement
During surgery
Contrast Enhancement

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

ALM-488-002a WLR with FL Overlay
1 of 4
ALM-488-002a WLR only
1 of 4
ALM-488-002b WLR only
1 of 4
ALM-488-002b WLR with FL Overlay
1 of 4
Experimental Treatment

200 Total Participants · 4 Treatment Groups

Primary Treatment: ALM-488-002a WLR with FL Overlay · No Placebo Group · Phase 3

ALM-488-002a WLR with FL OverlayExperimental Group · 2 Interventions: Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay, ALM-488 · Intervention Types: Other, Drug
ALM-488-002a WLR onlyExperimental Group · 2 Interventions: Intra-operative Visualization using White Light Reflectance (WLR), ALM-488 · Intervention Types: Other, Drug
ALM-488-002b WLR onlyExperimental Group · 2 Interventions: Intra-operative Visualization using White Light Reflectance (WLR), ALM-488 · Intervention Types: Other, Drug
ALM-488-002b WLR with FL OverlayExperimental Group · 2 Interventions: Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay, ALM-488 · Intervention Types: Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALM-488
2020
Completed Phase 2
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during surgery
Closest Location: University of Pennsylvania · Philadelphia, PA
Photo of Hospital of the University of Pennsylvania  1Photo of Hospital of the University of Pennsylvania  2Photo of University of Pennsylvania  3
2011First Recorded Clinical Trial
6 TrialsResearching Surgery
1048 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be at least 16 years of age to donate blood.
The study participant has undergone parotidectomy or thyroidectomy (unilateral or bilateral) or cervical neck dissection.
You are sexually active and willing to use an acceptable method of contraception (e.g., double barrier method) while participating in the study and for 30 days after receiving the last dose of ALM-488.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.