Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCity of Hope Medical Center

About this trial

This phase II trial compares standard of care surgical resection to fluorescence-guided surgical resection using indocyanine green and fluorescence imaging for reducing unexpected positive margin rates in patients with sarcoma. Surgical margins are one of the criteria used in assessing the effectiveness of a given surgical procedure. They are the edges or border of the tissue removed in cancer surgery. A negative margin means that the resected tumor is surrounded by normal tissue, which implies there is no disease left in the patient. By contrast, a positive margin means that sarcoma cells are visible at the edge of the tumor. Positive margins may be classified as planned when they are expected pre-operatively due to the preservation of a critical structure, or unexpected when the pathologist reports the presence of tumor at the margin despite the surgeon having intended to remove it in its entirety. Fluorescence-guided surgery is an established surgical method that involves the administration of fluorescent dye (in this case, indocyanine green) into the tumor, which can then be visualized with a special camera during surgery to help surgeons identify tumor versus healthy tissue. Fluorescence-guided surgery may reduce the rate of unexpected positive margins in patients undergoing surgery for sarcoma.

Eligibility criteria

Qualifiers

Documented written informed consent of the participant

Histologically confirmed diagnosis of intermediate to high grade sarcoma

All ages

Amenable to surgical resection as a part of curative intent for the patient

Disqualifiers

Due for surgery with palliative intent

Recurrent tumors

Intracranial, retroperitoneal, and visceral anatomical locations

A woman of childbearing potential who is currently pregnant (as confirmed by urine pregnancy test)

Trial design

Treatments tested in this trial

  • Electronic Health Record Review
  • Fluorescence Imaging
  • Fluorescence-Guided Surgery
  • Indocyanine Green
  • Questionnaire Administration
  • Resection

Treatment groups

22 Participants
are divided into 2 treatment groups

Locations

1
City of Hope Medical Center91010, DuarteCalifornia, United States

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator