RecruitingPhase 2

Intraoperative Tumor Margin Identification With ICG Dye Imaging

United States100 participantsStarted 2022-05-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Pregnant or nursing patients * Patients with previously known anaphylaxis to IV contrast or iodine (other allergies may be considered on a case-by-case basis) * Patients in renal failure who are not cleared for ICG administration by their primary physician or oncologist

What they're measuring

image-guided prediction of local recurrence

Timeframe: 2 Years

Trial details

NCT IDNCT04752137

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04-01

Contact for this trial

Santiago A Lozano-Calderon, MD, PhD

(617) 643-4947 SLOZANOCALDERON@mgh.harvard.edu

View on ClinicalTrials.gov More Benign Neoplasm trials