Dynamic Contrast-Enhanced Fluorescence Arthroscopy of Meniscus Pilot

May 15, 2023 updated by: Michael B. Sparks, Dartmouth-Hitchcock Medical Center

Single-center Pilot Prospective Observational Study to Determine Feasibility of Assessing Meniscal Tissue Vascularity Using Dynamic Contrast-enhanced Fluorescence Arthroscopy

Single-center pilot prospective observational study to determine feasibility of assessing meniscal tissue vascularity using dynamic contrast-enhanced fluorescence arthroscopy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this pilot study is to determine whether it is possible to translate the dynamic contrast-enhanced fluorescence imaging methods we have been using to assess bone perfusion in orthopaedic trauma patients to the field of arthroscopic surgery. In other words, it is the development of dynamic contrast-enhanced fluorescence arthroscopy.

While fluorescence arthroscopes are available, there are several challenges associated with minimally invasive procedures compared with wide field imaging, and this pilot study will help determine whether these can be overcome. They are mainly to do with motion artifacts caused by the non-fixed position of the scope during wash-in/wash-out of the dye, and the use of an arthroscopic pump to pressurize the fluid in the surgical cavity.

The long-term goal of this work is to use dynamic contrast-enhanced fluorescence arthroscopy for the assessment of vascularity of meniscal tissue arthroscopically to determine potential healing capacity using dynamic contrast-enhanced fluorescence imaging.

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Contact Backup

Study Locations

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. Patients 18 years of age or older.
  2. Meniscal tear based on MRI or preoperative assessment
  3. Provision of informed consent.

Exclusion Criteria:

  1. Inability of patient to provide informed consent
  2. Iodine allergy.
  3. Evidence of septic arthritis of the proposed surgical joint.
  4. Burns.
  5. Incarceration.
  6. Expected survival of less than 90 days.
  7. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
  8. Pregnant or Breastfeeding Women

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with a meniscal tear requiring surgery
Patients will be administered Food and Drug Administration (FDA) approved Indocyanine green (ICG) through intravenous injection and imaged by a FDA approved surgical fluorescence imaging device. Both ICG fluorescence and the imaging system have been used for routine clinical practice for many years. ICG fluorescence imaging utilizes intravenously injected ICG, which is a fluorescent dye that is FDA-approved for clinical use, illuminated with near-infrared light. The ICG dye is indirectly activated and the dynamic fluorescence due to meniscal perfusion can be captured by an arthroscopic imaging system.
Procedure: Perfusion with Indocyanine green
Infusion of Indocyanine green to determine perfusion in meniscal tear tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of meniscal blood supply using Indocyanine green (ICG)
Time Frame: Baseline, up to 20 minutes
The primary study outcome is to measure meniscal blood flow in patients during surgery.
Baseline, up to 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure setting (mm Hg) required for optimal visualization of ICG-based fluorescence.
Time Frame: Baseline, up to 20 minutes
assess the impact of arthroscopic pump pressure on the visualization of ICG-based dynamic contrast-enhanced fluorescence in the joint and to develop parameters around effect of the pump.
Baseline, up to 20 minutes

Collaborators and Investigators

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

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

KARL STORZ Endoscopy-America, Inc.

Investigators

  • Principal Investigator: Michael B Sparks, MD, Dartmouth-Hitchcock Medical Center

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)

January 12, 2022

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 28, 2021

First Posted (Actual)

October 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY02000782

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

product manufactured in and exported from the U.S.

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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