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New treatment option for High Grade Sarcoma
Official title Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial
ClinicalTrials.gov ID: NCT07650656
What this study is testing
What is Indocyanine Green?
Indocyanine Green is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for high grade sarcoma.
Also referred to as ICG.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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:
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.