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Knee InjuriesNCT05072717

Dynamic Contrast-Enhanced Fluorescence Arthroscopy of Meniscus Pilot

A study testing Perfusion with Indocyanine green in people with Knee Injuries, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Knee Injuries
What is being tested?
Perfusion with Indocyanine green
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
12 Jan 2022to 30 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions
Knee Injuries
Being tested
Perfusion with Indocyanine green
Keywords
meniscus, Indocyanine green, fluorescence, imaging
Medical subject headings
Knee Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perfusion with Indocyanine greenProcedure or surgery

    Infusion of Indocyanine green to determine perfusion in meniscal tear tissue.

Study groups in NCT05072717
Study groupRoleWhat they receive
Patients with a meniscal tear requiring surgeryExperimentalPatients 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.
Receives: Procedure: Perfusion with Indocyanine green

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of meniscal blood supply using Indocyanine green (ICG)

    The primary study outcome is to measure meniscal blood flow in patients during surgery.

    Measured: Baseline, up to 20 minutes

Secondary outcomes (1)

  1. 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.

    Measured: Baseline, up to 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2021
  2. Study start12 Jan 2022
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Why it stopped: At the time of writing the protocol, was unaware that there is already an established protocol in place within Geriatrics department to capture this data.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05072717
Sponsor's protocol ID
STUDY02000782
Status last verified
May 2024
First submitted
9 Sep 2021
Last updated
24 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29654348

  • 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.

    PubMed 28088373

  • 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.

    PubMed 27036169

  • 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.

    PubMed 30556360

  • 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.

    PubMed 24145951

  • 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.

    PubMed 28696850

  • 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.

    PubMed 22098511

  • 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.

    PubMed 26359355

  • 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.

    PubMed 25469765

  • 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.

    PubMed 22577366

  • 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.

    PubMed 25303914

Questions about this trial

What is this clinical trial studying?

A study testing Perfusion with Indocyanine green in people with Knee Injuries, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of meniscal blood supply using Indocyanine green (ICG) (time frame: Baseline, up to 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05072717, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.

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