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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06409013
Other study ID # 23-003589
Secondary ID NCI-2024-0348223
Status Recruiting
Phase
First received
Last updated
Start date March 14, 2024
Est. completion date March 30, 2027

Study information

Verified date May 2024
Source Mayo Clinic
Contact Clinical Trials Referral Office
Phone 855-776-0015
Email mayocliniccancerstudies@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 30, 2027
Est. primary completion date March 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non-Interventional Study
Non-interventional study

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of intraoperative ICG fluorescence compared to final pathology results Intraoperative ICG fluorescence and deduced margins will be analyzed and compared the accuracy to final pathology margins. Negative predictive value will be calculated. Baseline
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