Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial
Recruiting
Phase 2Interventional Study
High Grade SarcomaSarcoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
22 (estimated)
Sponsor
City of Hope Medical Center · Other
Who this trial is looking for
This trial is looking for patients with a type of cancer called sarcoma who are undergoing surgery. Participants will help researchers compare regular surgery to a new method that uses a special dye to help doctors see the cancer better during surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I have agreed to participate in this trial.
I have been diagnosed with intermediate to high grade sarcoma.
I am of any age.
I can have surgery to try to cure my cancer.
I am willing to respond to surveys during the trial.
I allow access to my medical records and lab results.
You may not be able to join if
I need surgery for comfort, not to cure my cancer.
I have tumors that came back after treatment.
I have tumors in my brain or certain other body areas.
I am currently pregnant.
I am currently breastfeeding.
I am allergic to indocyanine green or iodine.
I cannot provide consent for myself.
I have hyper-thyroidism or certain thyroid issues.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 sur…
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.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* 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
* Willingness to:
* Respond to surveys during the trial…
Inclusion Criteria:
* 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
* Willingness to:
* Respond to surveys during the trial
* Permit medical record/ clinical laboratory result review
Exclusion Criteria:
* 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)
* A woman who are currently breastfeeding
* Known allergies to ICG, iodine, iodine dyes or shellfish
* Unable to provide written and informed consent
* Patients with hyper-thyroidism or autonomic thyroid adenomas
* Premature infants/neonates with exchange transfusion indication due to hyperbilirubinemia
Contacts
No contact information available.
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