Dynamic Contrast-Enhanced Fluorescence Arthroscopy of Meniscus Pilot

Knee Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05072717
• Other study ID #: STUDY02000782
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Michael B Sparks, MD
• Phone: 1-603-65
• Email: michael.b.sparks[@]hitchcock.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Procedure:
• Perfusion with Indocyanine green
Infusion of Indocyanine green to determine perfusion in meniscal tear tissue.

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	KARL STORZ Endoscopy-America, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of meniscal blood supply using Indocyanine green (ICG)	The primary study outcome is to measure meniscal blood flow in patients during surgery.	Baseline, up to 20 minutes
Secondary	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.	Baseline, up to 20 minutes