Utility of ICG in Benign Bone Tumors
Primary Purpose
Bone Tumor
Status
Enrolling by invitation
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
About this trial
This is an interventional other trial for Bone Tumor focused on measuring Benign, Operative Management
Eligibility Criteria
Inclusion Criteria:
- Subjects 12 years of age or older
Diagnosis of any of the following that has been identified by imaging and/or biopsy:
- Enchondroma
- Periosteal chondroma
- Osteochondroma
- Chondroblastoma
- Giant cell tumor of bone
- Aneurysmal bone cyst
- Unicameral (aka Simple) bone cyst
- Chondromyxoid fibroma
- Osteoblastoma
- Desmoplastic fibroma
- Fibrous dysplasia
- Osteofibrous dysplasia
- Intralesional operative management for their tumor planned
- Written informed consent signed by the subject if 18 years of age or older or by parent(s) or legally authorized representative if younger than 18 years of age. If younger than 18 years of age, the child must be able to be assent.
Exclusion Criteria:
- Iodine allergy
- Women who are pregnant or breastfeeding
- Incarcerated individuals
Sites / Locations
- Dartmouth-Hitchock
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Benign Bone patients
Arm Description
Patients with Benign Bone tumors requiring intralesional operative management will be administered immunofluorescent indocyanine green 24 hours prior to surgery, imaging of perfused tissues will be performed at the time of tumor removal.
Outcomes
Primary Outcome Measures
Fluorescent intensity contrast
fluorescence contrast suitable to facilitate fluorescence-guided surgical resection of benign bone tumors (tumor-to-background ratio > 2.0)
Secondary Outcome Measures
Full Information
NCT ID
NCT05075889
First Posted
September 30, 2021
Last Updated
December 20, 2022
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05075889
Brief Title
Utility of ICG in Benign Bone Tumors
Official Title
A Single-center Study Investigating the Utility of Indocyanine Green (ICG) Fluorescence Imaging in Patients With Benign Bone Tumors Requiring Intralesional Operative Management
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with a biopsy-proven benign bone tumor for which standard of care is intralesional operative management will receive a weight-appropriate IV dose of indocyanine green (ICG, FDA-approved) the day prior to surgery during their standard pre-operative clinic visit. On the day of surgery, fluorescence images will be obtained using a non-invasive fluorescence camera.
Detailed Description
ICG fluorescence imaging has been used to assess tissue perfusion in vivo in real-time intra-operative arterial and lymphatic perfusion imaging and osseous flap perfusion imaging. Compared to the conventional medical imaging modalities, such as computed tomography (CT) or magnetic resonance imaging (MRI), ICG fluorescence imaging is nonionizing, low-cost, and portable. ICG is a dye that absorbs near-infrared light in the wavelength range between 790 to 805 nm and has an emission at the peak of 835 nm. ICG is almost 98% plasma protein-bound so that once it is received in the microcirculation, it remains within the lymphatic and circulatory vasculature unless inflammation is present. ICG has been approved for clinical use by the Food and Drug Administration (FDA) since 1959. Since then, ICG has been used in humans for angiography in ophthalmology and cardiology applications and is given routinely to patients in these clinical settings. ICG fluorescence imaging has also been used to guide laparoscopic surgery, robotic adrenalectomy, assess tissue perfusion in vivo in real-time intra-operative arterial and lymphatic perfusion imaging, and tissue flap perfusion imaging. ICG is ideal to measure perfusion/blood flow because it binds efficiently to blood lipoproteins and thus does not leak from circulation under normal circumstances. In addition, the ICG half-life is short making repeated measures possible, and it is indirectly activated, so that the dynamic fluorescence due to bone and tissue perfusion can be captured by a video rate imaging system.
The dynamic fluorescence imaging systems to be used in this study will be preferentially the Pentero surgical microscope (Zeiss, Germany), Spy Elite Imaging System or SPY Portable Handheld Imaging (SPY-PHI) System (Novadaq/Stryker), or another imager may be used. These imagers are commercially available imaging systems that are used to assess tissue perfusion in real time in the operating room. The systems have a multi-directional imaging arm which contains a near-infrared light source that illuminates the fluorescent agent within the tissues, a high definition (HD) video camera that captures the intensity of fluorescent marker in real-time, and software that allows the user to capture relative and absolute perfusion values within the surgical field. These products are FDA-approved for use to monitor blood flow, plastic surgery, microsurgery, reconstructive surgery, gastrointestinal imaging and coronary bypass surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Tumor
Keywords
Benign, Operative Management
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive the same study drug.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Benign Bone patients
Arm Type
Experimental
Arm Description
Patients with Benign Bone tumors requiring intralesional operative management will be administered immunofluorescent indocyanine green 24 hours prior to surgery, imaging of perfused tissues will be performed at the time of tumor removal.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Other Intervention Name(s)
ICG
Intervention Description
Enrolled subjects will receive Indocyanine Green administered the day prior to surgery during their standard-of-care preoperative appointment
Primary Outcome Measure Information:
Title
Fluorescent intensity contrast
Description
fluorescence contrast suitable to facilitate fluorescence-guided surgical resection of benign bone tumors (tumor-to-background ratio > 2.0)
Time Frame
24 hours post injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects 12 years of age or older
Diagnosis of any of the following that has been identified by imaging and/or biopsy:
Enchondroma
Periosteal chondroma
Osteochondroma
Chondroblastoma
Giant cell tumor of bone
Aneurysmal bone cyst
Unicameral (aka Simple) bone cyst
Chondromyxoid fibroma
Osteoblastoma
Desmoplastic fibroma
Fibrous dysplasia
Osteofibrous dysplasia
Intralesional operative management for their tumor planned
Written informed consent signed by the subject if 18 years of age or older or by parent(s) or legally authorized representative if younger than 18 years of age. If younger than 18 years of age, the child must be able to be assent.
Exclusion Criteria:
Iodine allergy
Women who are pregnant or breastfeeding
Incarcerated individuals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric R Henderson, MD
Organizational Affiliation
Dartmouth-Hithcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchock
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
12. IPD Sharing Statement
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Utility of ICG in Benign Bone Tumors
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