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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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 group | Role | What they receive |
|---|---|---|
| Patients with a meniscal tear requiring surgery | Experimental | 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. Receives: Procedure: Perfusion with Indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted11 Oct 2021
- Study start12 Jan 2022
- Primary completion30 Dec 2023 (estimated)
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- KARL STORZ Endoscopy-America, Inc.
- Responsible party
- Principal investigator, Michael B. Sparks, Dartmouth-Hitchcock Medical Center
- Investigators
- Michael B Sparks, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
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 29654348Fischer 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 28088373Fischer 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 27036169Muller 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 30556360Schoierer 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 24145951Martin 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 28696850Cahill 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 22098511Reinhart 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 26359355Valerio 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 25469765Alander 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 22577366Boni 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
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Pilot Prospective Observational Study to Determine Feasibility of Assessing Meniscal Tissue Vascularity Using Dynamic Contrast-enhanced Fluorescence Arthroscopy
- ClinicalTrials.gov ID
- NCT05072717
- Acronym / sponsor ID
- STUDY02000782
- Conditions
- Knee Injuries
- Keywords
- meniscus, Indocyanine green, fluorescence, imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- KARL STORZ Endoscopy-America, Inc.
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a meniscal tear requiring surgery | Experimental | Procedure: Perfusion with Indocyanine greenPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years of age or older.
- Meniscal tear based on MRI or preoperative assessment
- Provision of informed consent.
Key exclusion criteria (8 listed)
- Inability of patient to provide informed consent
- Iodine allergy.
- Evidence of septic arthritis of the proposed surgical joint.
- Burns.
- Incarceration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perfusion with Indocyanine greenInfusion of Indocyanine green to determine perfusion in meniscal tear tissue. | Procedure or surgery | Patients with a meniscal tear requiring surgery |
Primary outcome
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.
1 secondary outcome
Pressure setting (mm Hg) required for optimal visualization of ICG-based fluorescence.
Time frame: Baseline, up to 20 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Background: PubMed 29654348Liao 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.
- Background: PubMed 28088373Fischer 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.
- Background: PubMed 27036169Fischer 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.
- Background: PubMed 30556360Muller 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.
- Background: PubMed 24145951Schoierer 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.
- Background: PubMed 28696850Martin 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.
- Background: PubMed 22098511Cahill 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.
- Background: PubMed 26359355Reinhart 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.
- Background: PubMed 25469765Valerio 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.
- Background: PubMed 22577366Alander 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.
- Background: PubMed 25303914Boni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Sparks, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
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.