Utility of ICG in Benign Bone Tumors

NCT05075889 | Completed Early Phase 1 FDA Drug

• 1 other identifier: STUDY02000819
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Tumor

Keywords

Benign; Operative Management

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Benign Bone patients

EXPERIMENTAL

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

Interventions

Indocyanine Green DRUG

Enrolled subjects will receive Indocyanine Green administered the day prior to surgery during their standard-of-care preoperative appointment

Also known as: ICG

Benign Bone patients

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Iodine allergy
• Women who are pregnant or breastfeeding
• Incarcerated individuals

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchock

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Eric R Henderson, MD

  Dartmouth-Hithcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedics

Model Details: All participants will receive the same study drug.

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 13, 2021
• Study Start: November 11, 2021
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: May 14, 2024

Record last verified: 2024-04

Locations

US (1)