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NCT Number: NCT06409013

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

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

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Key information

Conditions

Bone Sarcoma Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Sarcoma Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • * Age less than 18
  • Chronic kidney disease
  • Anaphylaxis to dyes

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Accuracy of intraoperative ICG fluorescence compared to final pathology results

    Time frame: Baseline

    Intraoperative ICG fluorescence and deduced margins will be analyzed and compared the accuracy to final pathology margins. Negative predictive value will be calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Laura Dohrmann

CONTACT

[email protected]

507-266-5886

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Sarcoma Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 10, 2024
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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