NCT04752137 Intraoperative Tumor Margin Identification With ICG Dye Imaging
| NCT ID | NCT04752137 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Benign Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-05-25 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 100 participants in total. It began in 2022-05-25 with a primary completion date of 2028-04-01.
⚠ 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
In this research study we want to learn more about the use of indocyanine green (ICG) during bone or soft tissue mass resections. Indocyanine green (ICG) is a type of dye that is used in medical diagnostics. We want to determine if ICG-guided tumor resection is more effective in obtaining negative margins. Lastly, we want to assess traditional oncologic outcomes of local recurrence, time to metastatic disease, and overall and disease specific survival.
Eligibility Criteria
Inclusion Criteria: * All patients 18 years of age or older who present to Massachusetts General Hospital Department of Orthopaedic Surgery with a benign or malignant bone or soft tissue mass that is consented for surgery during the study period. Exclusion Criteria: * Pregnant or nursing patients * Patients with previously known anaphylaxis to IV contrast or iodine (other allergies may be considered on a case-by-case basis) * Patients in renal failure who are not cleared for ICG administration by their primary physician or oncologist
Contact & Investigator
Santiago A Lozano-Calderon, MD, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT04752137 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Benign Neoplasm. 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 NCT04752137 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 NCT04752137 currently recruiting?
Yes, NCT04752137 is actively recruiting participants. Contact the research team at SLOZANOCALDERON@mgh.harvard.edu for enrollment information.
Where is the NCT04752137 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04752137 clinical trial?
NCT04752137 is sponsored by Massachusetts General Hospital. The principal investigator is Santiago A Lozano-Calderon, MD, PhD at Massachusetts General Hospital. The trial plans to enroll 100 participants.