Neurofilament Light Protein in Peripheral Blood Used as a Biomarker for Neurotoxicity After Isolated Limb Perfusion. (ILP-NfL)

April 22, 2024 updated by: Roger Olofsson Bagge, Vastra Gotaland Region

A Prospective Feasibility Trial Measuring Neurofilament Light Protein in Peripheral Blood as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.

A prospective feasibility trial initially including 10 patients to investigate if Neurofilament light protein can be detected in peripheral blood in patients undergoing Isolated Limb Perfusion with chemotherapeutic agents. This biomarker could act as predictive biomarker for neurotoxicity after isolated limb perfusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In isolated limb perfusion (ILP) neurotoxicity is a known side effect, this is in spite of the fact that a relatively mild hyperthermic temperature is used which should be well tolerated by the nerves and other normal tissues in the limbs. It seems probable that the neurotoxicity observed after ILP results from both a thermal enhancement of drug toxicity combined with a local effect of a high tourniquet pressure that is used to isolate the blood flow. Prevention of regional and systemic toxicity is essential for improving the outcome after the procedure. It is known that both higher doses of melphalan, higher temperatures and longer perfusion time correlates to a higher toxicity. The Wieberdink method is a grading system for the reaction of the normal tissues after ILP and the grading is used as a routine in ILP today. Neurofilament light protein (NfL) is released into the cerebrospinal fluid (CSF) during axonal damage and has been shown to be elevated in different forms of dementia. An NfL assay sensitive enough to measure NfL in blood was recently developed. Its concentration reflects axonal injury in both central and peripheral nervous system disorders.The primary aim of this study is to investigate the possibility to measure neurofilament as a biomarker for peripheral nerve toxicity after isolated limb perfusion.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient scheduled for treatment with isolated limb perfusion
  2. Age over 18 years
  3. Signed informed consent

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurofilament light protein measurement
Neurofilament light protein measurements in peripheral blood pre- peri- and postoperatively.
Procedure: Neurofilament light protein measurement in Isolated limb perfused patients
A prospective feasibility trial measuring neurofilament light protein in peripheral blood as a biomarker for neurotoxicity after isolated limb perfusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurofilament light protein measurement in peripheral blood
Time Frame: 1 day postoperatively
Neurofilament light protein
1 day postoperatively
Neurofilament light protein measurement in peripheral blood
Time Frame: 3 days postoperatively
Neurofilament light protein
3 days postoperatively
Neurofilament light protein measurement in peripheral blood
Time Frame: 4 weeks postoperatively
Neurofilament light protein
4 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: Roger Olofsson Bagge, Sahlgrenska University Hospital, Department of Sugery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2019

Primary Completion (Actual)

September 18, 2020

Study Completion (Actual)

October 25, 2020

Study Registration Dates

First Submitted

May 9, 2019

First Submitted That Met QC Criteria

July 5, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILP-NfL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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