Utility of ICG in Benign Bone Tumors

A Single-center Study Investigating the Utility of Indocyanine Green (ICG) Fluorescence Imaging in Patients With Benign Bone Tumors Requiring Intralesional Operative Management

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.

Study Overview

• Status: Completed
• Conditions: Bone Tumor
• Intervention / Treatment: Drug: Indocyanine Green

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects 12 years of age or older

2. Diagnosis of any of the following that has been identified by imaging and/or biopsy:

   1. Enchondroma
   2. Periosteal chondroma
   3. Osteochondroma
   4. Chondroblastoma
   5. Giant cell tumor of bone
   6. Aneurysmal bone cyst
   7. Unicameral (aka Simple) bone cyst
   8. Chondromyxoid fibroma
   9. Osteoblastoma
   10. Desmoplastic fibroma
   11. Fibrous dysplasia
   12. Osteofibrous dysplasia
3. Intralesional operative management for their tumor planned
4. 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:

1. Iodine allergy
2. Women who are pregnant or breastfeeding
3. Incarcerated individuals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Benign Bone patients; 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.	Drug: Indocyanine Green; Enrolled subjects will receive Indocyanine Green administered the day prior to surgery during their standard-of-care preoperative appointment; Other Names: ICG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluorescent intensity contrast	fluorescence contrast suitable to facilitate fluorescence-guided surgical resection of benign bone tumors (tumor-to-background ratio > 2.0)	24 hours post injection

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Eric R Henderson, MD, Dartmouth-Hithcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): April 20, 2022

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Benign; Operative Management
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Bone Neoplasms
• Other Study ID Numbers: STUDY02000819

Drug and device information, study documents

• 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