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.
Additional locations may be listed on ClinicalTrials.gov for NCT04752137.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer CenterStatus: Active
Name Not Available
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.
Lead OrganizationMassachusetts General Hospital
Principal InvestigatorSantiago Lozano-Calderon