Intraoperative Tumor Margin Identification With ICG Dye Imaging

Malignant Neoplasm Clinical Trial

Official title: Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

If you are present for a preoperative clinic visit the day before your surgery, ICG may be administered via injection. Otherwise, ICG will be administered in the preoperative unit via IV injection at the time of presentation approximately 4 hours before your surgery. You will be monitored during and after ICG dosing.

During surgery ICG fluorescence using a near-infrared imager will be performed at the time of and immediately following primary tumor resection. The imager will evaluate the primary tumor to ensure appropriate tumor fluorescence. Once the primary resection is complete and the surgeon believes that he/she has achieved negative or planned positive margins, fluorescence measurements of the tumor bed will be performed. If areas of positive signal remain, these areas will be resected if possible and sent to pathology for histologic evaluation. It will be recorded if the surgeon perceived negative margins but the device detected positive margins.

Tumor specimens and residual fluorescence positive samples will be evaluated using fresh frozen and permanent histology. Permanent samples will be evaluated for tumor and local fluorescence using confocal microscopy with an ICG cube. Positive fluorescence signal and its correspondence with neoplasm will be noted, a will tumor that does not fluoresce.

Tissue being removed is 1-2 mm from non-structurally important tissue that either has or does not have signal positivity for additional pathologic assessment. It should have no impact on patient outcome, does not represent intervention on sensitive areas (such as neurovascular structures), and can further be used as potential margin around the tumor. ;

Related Conditions & MeSH terms

• Benign Neoplasm
• Malignant Neoplasm
• Neoplasms

• NCT number: NCT04752137
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Joseph Werenski, BS
• Phone: (617) 726-4932
• Email: jwerenski@mgh.harvard.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: May 25, 2022
• Completion date: October 1, 2025