Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
Who is this study for? Patients with Neoplasm
What treatments are being studied? Indocyanine Green+SPY-PHI
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
In this research study we want to learn more about the use of indocyanine green (ICG) during bone or soft tissue mass resections. Indocyanine green (ICG) is a type of dye that is used in medical diagnostics. We want to determine if ICG-guided tumor resection is more effective in obtaining negative margins. Lastly, we want to assess traditional oncologic outcomes of local recurrence, time to metastatic disease, and overall and disease specific survival.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• All patients 18 years of age or older who present to Massachusetts General Hospital Department of Orthopaedic Surgery with a benign or malignant bone or soft tissue mass that is consented for surgery during the study period.
Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Santiago A Lozano-Calderon, MD, PhD
SLOZANOCALDERON@mgh.harvard.edu
(617) 643-4947
Backup
Shreya Halur, BS
shalur@mgh.harvard.edu
(617) 726-4932
Time Frame
Start Date: 2022-05-25
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 100
Treatments
Other: ICG Dye and use of SPY-PHI Imaging
ICG will be administered in the pre-operative unit via IV injection at the time that they present to the pre-operative unit, which is approximately 4 hours before surgery. ICG Angiography (SPY PHI) will be performed to detect any residual signal
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital