Utility of ICG in Benign Bone Tumors

• Status: Not yet recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Criteria

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