Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752137
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2021-02-03
Brief Title:
Intraoperative Tumor Margin Identification With ICG Dye Imaging
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 heshe 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
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 heshe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None