search
Back to results

Dynamic Contrast-Enhanced Fluorescence Arthroscopy of Meniscus Pilot

Primary Purpose

Knee Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perfusion with Indocyanine green
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Injuries focused on measuring meniscus, Indocyanine green, fluorescence, imaging

Eligibility Criteria

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

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

Sites / Locations

  • Dartmouth Hitchcock Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with a meniscal tear requiring surgery

Arm Description

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.

Outcomes

Primary Outcome Measures

Measurement of meniscal blood supply using Indocyanine green (ICG)
The primary study outcome is to measure meniscal blood flow in patients during surgery.

Secondary Outcome Measures

Pressure setting (mm Hg) required for optimal visualization of ICG-based fluorescence.
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.

Full Information

First Posted
September 9, 2021
Last Updated
May 15, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
KARL STORZ Endoscopy-America, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05072717
Brief Title
Dynamic Contrast-Enhanced Fluorescence Arthroscopy of Meniscus Pilot
Official Title
Single-center Pilot Prospective Observational Study to Determine Feasibility of Assessing Meniscal Tissue Vascularity Using Dynamic Contrast-enhanced Fluorescence Arthroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
KARL STORZ Endoscopy-America, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
meniscus, Indocyanine green, fluorescence, imaging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with a meniscal tear requiring surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Perfusion with Indocyanine green
Intervention Description
Infusion of Indocyanine green to determine perfusion in meniscal tear tissue.
Primary Outcome Measure Information:
Title
Measurement of meniscal blood supply using Indocyanine green (ICG)
Description
The primary study outcome is to measure meniscal blood flow in patients during surgery.
Time Frame
Baseline, up to 20 minutes
Secondary Outcome Measure Information:
Title
Pressure setting (mm Hg) required for optimal visualization of ICG-based fluorescence.
Description
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.
Time Frame
Baseline, up to 20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18 years of age or older. Meniscal tear based on MRI or preoperative assessment Provision of informed consent. Exclusion Criteria: Inability of patient to provide informed consent Iodine allergy. Evidence of septic arthritis of the proposed surgical joint. Burns. Incarceration. Expected survival of less than 90 days. Problems, in the judgment of study personnel, with maintaining follow-up with the patient. Pregnant or Breastfeeding Women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael B Sparks, MD
Phone
1-603-65
Email
michael.b.sparks@hitchcock.org
First Name & Middle Initial & Last Name or Official Title & Degree
Holly B Symonds
Phone
603-653-9440
Email
holly.b.symonds@hitchcock.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Sparks, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael B Sparks, MD
Phone
603-650-5133
Email
michael.b.sparks@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Holly B Symonds
Phone
603-653-9440
Email
holly.b.symonds@hitchcock.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29654348
Citation
Liao D, Xie L, Han Y, Du S, Wang H, Zeng C, Li Y. Dynamic contrast-enhanced magnetic resonance imaging for differentiating osteomyelitis from acute neuropathic arthropathy in the complicated diabetic foot. Skeletal Radiol. 2018 Oct;47(10):1337-1347. doi: 10.1007/s00256-018-2942-4. Epub 2018 Apr 13.
Results Reference
background
PubMed Identifier
28088373
Citation
Fischer C, Nissen M, Schmidmaier G, Bruckner T, Kauczor HU, Weber MA. Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for the prediction of non-union consolidation. Injury. 2017 Feb;48(2):357-363. doi: 10.1016/j.injury.2017.01.021. Epub 2017 Jan 9.
Results Reference
background
PubMed Identifier
27036169
Citation
Fischer C, Preuss EM, Tanner M, Bruckner T, Krix M, Amarteifio E, Miska M, Moghaddam-Alvandi A, Schmidmaier G, Weber MA. Dynamic Contrast-Enhanced Sonography and Dynamic Contrast-Enhanced Magnetic Resonance Imaging for Preoperative Diagnosis of Infected Nonunions. J Ultrasound Med. 2016 May;35(5):933-42. doi: 10.7863/ultra.15.06107. Epub 2016 Apr 1.
Results Reference
background
PubMed Identifier
30556360
Citation
Muller G, Mansson S, Muller MF, Johansson M, Bjorkman A. Increased perfusion in dynamic gadolinium-enhanced MRI correlates with areas of bone repair and of bone necrosis in patients with Kienbock's disease. J Magn Reson Imaging. 2019 Aug;50(2):481-489. doi: 10.1002/jmri.26573. Epub 2018 Dec 16.
Results Reference
background
PubMed Identifier
24145951
Citation
Schoierer O, Bloess K, Bender D, Burkholder I, Kauczor HU, Schmidmaier G, Weber MA. Dynamic contrast-enhanced magnetic resonance imaging can assess vascularity within fracture non-unions and predicts good outcome. Eur Radiol. 2014 Feb;24(2):449-59. doi: 10.1007/s00330-013-3043-3. Epub 2013 Oct 22.
Results Reference
background
PubMed Identifier
28696850
Citation
Martin Noguerol T, Luna Alcala A, Beltran LS, Gomez Cabrera M, Broncano Cabrero J, Vilanova JC. Advanced MR Imaging Techniques for Differentiation of Neuropathic Arthropathy and Osteomyelitis in the Diabetic Foot. Radiographics. 2017 Jul-Aug;37(4):1161-1180. doi: 10.1148/rg.2017160101.
Results Reference
background
PubMed Identifier
22098511
Citation
Cahill RA, Ris F, Mortensen NJ. Near-infrared laparoscopy for real-time intra-operative arterial and lymphatic perfusion imaging. Colorectal Dis. 2011 Nov;13 Suppl 7:12-7. doi: 10.1111/j.1463-1318.2011.02772.x.
Results Reference
background
PubMed Identifier
26359355
Citation
Reinhart MB, Huntington CR, Blair LJ, Heniford BT, Augenstein VA. Indocyanine Green: Historical Context, Current Applications, and Future Considerations. Surg Innov. 2016 Apr;23(2):166-75. doi: 10.1177/1553350615604053. Epub 2015 Sep 10.
Results Reference
background
PubMed Identifier
25469765
Citation
Valerio I, Green JM 3rd, Sacks JM, Thomas S, Sabino J, Acarturk TO. Vascularized osseous flaps and assessing their bipartate perfusion pattern via intraoperative fluorescence angiography. J Reconstr Microsurg. 2015 Jan;31(1):45-53. doi: 10.1055/s-0034-1383821. Epub 2014 Dec 3.
Results Reference
background
PubMed Identifier
22577366
Citation
Alander JT, Kaartinen I, Laakso A, Patila T, Spillmann T, Tuchin VV, Venermo M, Valisuo P. A review of indocyanine green fluorescent imaging in surgery. Int J Biomed Imaging. 2012;2012:940585. doi: 10.1155/2012/940585. Epub 2012 Apr 22.
Results Reference
background
PubMed Identifier
25303914
Citation
Boni L, David G, Mangano A, Dionigi G, Rausei S, Spampatti S, Cassinotti E, Fingerhut A. Clinical applications of indocyanine green (ICG) enhanced fluorescence in laparoscopic surgery. Surg Endosc. 2015 Jul;29(7):2046-55. doi: 10.1007/s00464-014-3895-x. Epub 2014 Oct 11.
Results Reference
background

Learn more about this trial

Dynamic Contrast-Enhanced Fluorescence Arthroscopy of Meniscus Pilot

We'll reach out to this number within 24 hrs