Evaluation of Tumor Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography in Patients With Sarcoma

NCT06409013 — Recruiting, 75 participants, Mayo Clinic

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Sarcoma Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography

Registry	NCT06409013
Status	Recruiting
Study type	Observational
Enrollment	75 (Estimated)
Sponsor	Mayo Clinic (Other)
Conditions	Bone Sarcoma, Soft Tissue Sarcoma
Interventions	Non-Interventional Study (Other)
Dates	start 2024-03-14, primary completion 2027-03-30 (estimated), completion 2027-03-30 (estimated), first posted 2024-05-10, last updated 2026-08-04
Locations	1 site in United States

-Summary

This study evaluates the effectiveness of intraoperative indocyanine green dye and fluoroscopic technology in confirming negative margins after tumor removal.

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+Detailed description

PRIMARY OBJECTIVE:

I. To evaluate the use of indocyanine green (ICG) as an intraoperative guide during bone and soft tissue sarcoma resection.

OUTLINE: This is an observational study.

Patients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study.

+Arms and interventions

Arm	Type	Interventions	Description
Observational		Other: Non-Interventional Study	Patients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study.

Non-Interventional Study (Other): Non-interventional study

+Outcome measures

Primary outcomes

Accuracy of intraoperative ICG fluorescence compared to final pathology results [Baseline]: Intraoperative ICG fluorescence and deduced margins will be analyzed and compared the accuracy to final pathology margins. Negative predictive value will be calculated.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients with biopsy-proven bone or soft tissue sarcoma undergoing resection

Exclusion Criteria:

* Chronic kidney disease
* Anaphylaxis to dyes

+Locations (1)

Facility	City	Country	Status
Mayo Clinic in Rochester	Rochester, Minnesota	United States	Recruiting

+Investigators

Matthew T. Houdek, M.D., Principal investigator, Mayo Clinic in Rochester