NCT04719156 Fluorescent Intra-operative Tumor Margin Examination
| NCT ID | NCT04719156 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Kurt Weiss |
| Condition | Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2021-03-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 110 participants in total. It began in 2021-03-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Kurt E Weiss
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT04719156 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04719156 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04719156 currently recruiting?
Yes, NCT04719156 is actively recruiting participants. Contact the research team at krawbx@upmc.edu for enrollment information.
Where is the NCT04719156 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT04719156 clinical trial?
NCT04719156 is sponsored by Kurt Weiss. The principal investigator is Kurt E Weiss at University of Pittsburgh. The trial plans to enroll 110 participants.