RECRUITING

Fluorescent Intra-operative Tumor Margin Examination

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 expensive, time consuming, and only assesses the margin contained within the specific sample. In prior work the investigators have determined that indocyanine green (ICG) is highly specific to the tumor bed when injected shortly before surgery. The investigators hypothesize that ICG will be able to accurately identify residual positive tumor margins during sarcoma excision procedures.

Official Title

Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging

Quick Facts

Study Start:2021-03-02
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04719156

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients above the age of 18 with a primary musculoskeletal tumor that has been indicated for surgical excision by a fellowship trained orthopaedic oncologist.
  2. * Surgical consent was obtained prior to research consent.
  3. * 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.
  1. * Patients below the age of 18
  2. * Pregnancy, breast feeding
  3. * Patients with a history of anaphylactic reaction to contrast media or fluorescein allergy
  4. * Prior surgery local to the mass being excised
  5. * Non- or minimally-recurrent masses (i.e. osteochondroma)
  6. * Dialysis, renal failure, uremia

Contacts and Locations

Study Contact

Beata Krawczyk, krawbx@upmc.edu
CONTACT
412-401-3000
krawbx@upmc.edu
Kurt Weiss, MD
CONTACT
4128024100
weiskr@upmc.edu

Principal Investigator

Kurt E Weiss
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Alma E Heyl
Pittsburgh, Pennsylvania, 15232
United States

Collaborators and Investigators

Sponsor: Kurt Weiss

  • Kurt E Weiss, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-02
Study Completion Date2025-06

Study Record Updates

Study Start Date2021-03-02
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Sarcoma