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