Status:

RECRUITING

Fluorescent Intra-operative Tumor Margin Examination

Lead Sponsor:

Kurt Weiss

Collaborating Sponsors:

Stryker Nordic

Conditions:

Sarcoma

Eligibility:

All Genders

18-100 years

Phase:

PHASE2

Brief Summary

Tumor margin confirmation is important to confirming appropriate disease excision. Current standard of care is to take select margin samples to pathology for intra-operative readings. However, this is...

Detailed Description

Experimental Design: 1. A physician investigator will obtain consent during the pre-operative appointment. Study team members may assist with the discussion. 2. Upon arrival to the pre-operative area...

Eligibility Criteria

Inclusion

  • Patients above the age of 18 with a primary musculoskeletal tumor that has been indicated for surgical excision by a fellowship trained orthopaedic oncologist.
  • Surgical consent was obtained prior to research consent.
  • Patients with a biopsy-confirmed primary soft tissue or bone tumor that has not been previously excised and has a known risk of local or remote recurrence.

Exclusion

  • Patients below the age of 18
  • Pregnancy, breast feeding
  • Patients with a history of anaphylactic reaction to contrast media or fluorescein allergy
  • Prior surgery local to the mass being excised
  • Non- or minimally-recurrent masses (i.e. osteochondroma)
  • Dialysis, renal failure, uremia

Key Trial Info

Start Date :

March 2 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT04719156

Start Date

March 2 2021

End Date

December 31 2025

Last Update

February 19 2025

Active Locations (1)

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1

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States, 15213