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

Primary Purpose

Malignant Melanoma

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Neurofilament light protein measurement in Isolated limb perfused patients
Sponsored by
Roger Olofsson Bagge, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Melanoma focused on measuring toxicity, biomarker, Neurofilament Light protein, In-transit metastasis, Hyperthermic isolated limb perfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurofilament light protein measurement

Arm Description

Neurofilament light protein measurements in peripheral blood pre- peri- and postoperatively.

Outcomes

Primary Outcome Measures

Neurofilament light protein measurement in peripheral blood
Neurofilament light protein
Neurofilament light protein measurement in peripheral blood
Neurofilament light protein
Neurofilament light protein measurement in peripheral blood
Neurofilament light protein

Secondary Outcome Measures

Full Information

First Posted
May 9, 2019
Last Updated
March 16, 2021
Sponsor
Roger Olofsson Bagge, MD, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT04460053
Brief Title
Neurofilament Light Protein in Peripheral Blood Used as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.
Acronym
ILP-NfL
Official Title
A Prospective Feasibility Trial Measuring Neurofilament Light Protein in Peripheral Blood as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 12, 2019 (Actual)
Primary Completion Date
September 18, 2020 (Actual)
Study Completion Date
October 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Roger Olofsson Bagge, MD, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
Keywords
toxicity, biomarker, Neurofilament Light protein, In-transit metastasis, Hyperthermic isolated limb perfusion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective feasibility trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurofilament light protein measurement
Arm Type
Experimental
Arm Description
Neurofilament light protein measurements in peripheral blood pre- peri- and postoperatively.
Intervention Type
Procedure
Intervention Name(s)
Neurofilament light protein measurement in Isolated limb perfused patients
Intervention Description
A prospective feasibility trial measuring neurofilament light protein in peripheral blood as a biomarker for neurotoxicity after isolated limb perfusion.
Primary Outcome Measure Information:
Title
Neurofilament light protein measurement in peripheral blood
Description
Neurofilament light protein
Time Frame
1 day postoperatively
Title
Neurofilament light protein measurement in peripheral blood
Description
Neurofilament light protein
Time Frame
3 days postoperatively
Title
Neurofilament light protein measurement in peripheral blood
Description
Neurofilament light protein
Time Frame
4 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient scheduled for treatment with isolated limb perfusion Age over 18 years Signed informed consent Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Olofsson Bagge
Organizational Affiliation
Sahlgrenska University Hospital, Department of Sugery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35575302
Citation
Corderfeldt Keiller A, Holmen A, Hansson C, Ricksten SE, Bragadottir G, Olofsson Bagge R. Non-invasive and invasive measurement of skeletal muscular oxygenation during isolated limb perfusion. Perfusion. 2023 Jul;38(5):1019-1028. doi: 10.1177/02676591221093201. Epub 2022 May 16.
Results Reference
derived

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Neurofilament Light Protein in Peripheral Blood Used as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.

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