NCT06409013

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Mar 2024Mar 2027

Study Start

First participant enrolled

March 14, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

May 7, 2024

Last Update Submit

February 4, 2026

Conditions

Soft Tissue SarcomaBone Sarcoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with biopsy-proven bone or soft tissue sarcoma undergoing resection recruited through Mayo Clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Bone NeoplasmsSarcoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Study Officials

  • Matthew T. Houdek, M.D.

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015mayocliniccancerstudies@mayo.edu

Laura Dohrmann

CONTACT

507-266-5886Beinborn.Laura@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 10, 2024

Study Start

March 14, 2024

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

US(1)