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Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy

Primary Purpose

Rotator Cuff Tears

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients has full or partial thickness rotator cuff tear and is scheduled to undergo arthroscopic rotator cuff repair
  • Patient is at least 18 years of age and less than 80 years of age

Exclusion Criteria:

  • Patient is less than 18 years of age or greater than 79 years of age
  • Patient has a documented allergy to iodides
  • Patients who have had iodide based radiology studies within the last seven (7) days prior to surgery
  • Patient is pregnant

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1:ICG 7.5 mg

Group 2:ICG 12.5 mg

Group 3: ICG 25 mg

Arm Description

Subjects in this group are randomized to receive 7.5 mg dose of Indocyanine Green (ICG) intravenously during the clinical surgery. ICG is a substance that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision.

Subjects in this group are randomized to receive 12.5 mg dose of Indocyanine Green (ICG) intravenously during the clinical surgery. ICG is a substance that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision.

Subjects in this group are randomized to receive 25 mg dose of Indocyanine Green (ICG) intravenously during the clinical surgery. ICG is a substance that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision.

Outcomes

Primary Outcome Measures

Optimal dosing of an intravenous fluorescence solution (ICG) for arthroscopic evaluation of rotator cuff vascularity
Advanced Imaging Modality (AIM) arthroscopy videos for each dosing arm will be collected and five signal intensity readings will be collected from the rotator cuff within each video. The ability to visualize rotator cuff vascularity will be graded by surgeons blinded to the ICG dosing using a 5 point Likert scale where 1 indicates worst visibility and 5 indicates best visibility. Post-hoc ANOVA analysis of surgeons' responses to determine what dose of ICG is optimal for the surgery.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2020
Last Updated
September 5, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04340752
Brief Title
Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy
Official Title
Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy: A Prospective, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rotator cuff re-tear is a common delayed complication of arthroscopic rotator cuff repair. This process of re-tear is multifactorial and there has not been any readily identifiable perioperative measure that is predictive of subsequent rotator cuff failure. There have been no human studies looking at intraoperative assessment of rotator cuff vascularity, nor the predictive value that vascularity may have for rotator cuff re-tear. Indocyanine Green (ICG) has been safely used in patients for visualization purposes and has real potential for identifying vascularity in arthroscopic surgical patients. The aim of this study is to establish a standard dosing protocol for ICG in the arthroscopic visualization of rotator cuff vascularity.
Detailed Description
The primary study objective is to determine optimal dosing of an intravenous fluorescence solution (IC-Green) for arthroscopic evaluation of rotator cuff vascularity. The primary endpoint is surgeon's ability to assess vascularity within the rotator cuff based on a 5-point likert scale. The likert values from each of the three doses will undergo an ANOVA test to compare means of the three doses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1:ICG 7.5 mg
Arm Type
Experimental
Arm Description
Subjects in this group are randomized to receive 7.5 mg dose of Indocyanine Green (ICG) intravenously during the clinical surgery. ICG is a substance that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision.
Arm Title
Group 2:ICG 12.5 mg
Arm Type
Experimental
Arm Description
Subjects in this group are randomized to receive 12.5 mg dose of Indocyanine Green (ICG) intravenously during the clinical surgery. ICG is a substance that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision.
Arm Title
Group 3: ICG 25 mg
Arm Type
Experimental
Arm Description
Subjects in this group are randomized to receive 25 mg dose of Indocyanine Green (ICG) intravenously during the clinical surgery. ICG is a substance that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Intervention Description
ICG is an injectable fluorescent pigment that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision. The ICG will not affect the course of the operative or postoperative period, and will be injected intravenously prior to the actual repair
Primary Outcome Measure Information:
Title
Optimal dosing of an intravenous fluorescence solution (ICG) for arthroscopic evaluation of rotator cuff vascularity
Description
Advanced Imaging Modality (AIM) arthroscopy videos for each dosing arm will be collected and five signal intensity readings will be collected from the rotator cuff within each video. The ability to visualize rotator cuff vascularity will be graded by surgeons blinded to the ICG dosing using a 5 point Likert scale where 1 indicates worst visibility and 5 indicates best visibility. Post-hoc ANOVA analysis of surgeons' responses to determine what dose of ICG is optimal for the surgery.
Time Frame
up to 6 months post operative visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients has full or partial thickness rotator cuff tear and is scheduled to undergo arthroscopic rotator cuff repair Patient is at least 18 years of age and less than 80 years of age Exclusion Criteria: Patient is less than 18 years of age or greater than 79 years of age Patient has a documented allergy to iodides Patients who have had iodide based radiology studies within the last seven (7) days prior to surgery Patient is pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Moore
Phone
3475540183
Email
Michael.Moore@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirk Campbell
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Avila
Phone
786-269-3839
Email
amanda.avila@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Kirk Campbell, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to kirk.campbell@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy

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