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The purpose of this study is to assess the feasibility and safety of ICG-guided intraoperative lymphography for detecting sentinel lymph nodes (SLN) in pediatric patients with solid tumors who require retroperitoneal lymph node dissection/sampling.
This trial is a single-site cross-sectional study. The injection of ICG directly into lymphatics draining the primary tumor will take place at the time of operation after the patient is under anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indocyanine Green (ICG) and KARL STORZ ICG Imaging System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG (Indocyanine Green) | Diagnostic Test | Lymphatic mapping |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients with Successful Sentinel Lymph Node (SLN) Detection Using ICG Fluorescence | Success is defined as the intraoperative identification of at least one fluorescent sentinel lymph node (SLN) after indocyanine green (ICG) injection using an Iridium system optimized for near-infrared detection. Visualization of the SLN indicates uptake of ICG within the lymphatic basin. | Baseline |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of SLN Biopsy as Measured by Concordance Between SLN Pathology and Nodal Basin Pathology | Accuracy is assessed by comparing the pathology results of the SLN and the retroperitoneal lymph node basin dissection. True positives and true negatives are defined as SLN and nodal basin showing matching tumor status (both positive or both negative). Discordant finding is defined as tumor basin positive for tumor while SLN is negative for tumor. Discordant findings are considered false negatives. A tumor positive SLN in a tumor negative nodal basin is not considered discordant or false positive because sentinel may be the first and only tumor involved lymph node within the nodal basin. |
Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients aged 1 month to 17 years with diagnosed solid tumors who are receiving care at the University of Rochester Medical Center (URMC), Department of Surgery. Eligible participants are those scheduled to undergo lymph node sampling as part of standard clinical management. Participants will be identified through pediatric oncology, pediatric surgery, and tumor board evaluations.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdelhafeez Abdelhafeez, MD | Contact | Abdelhafeez_Abdelhafeez@URMC.Rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D012208 | Rhabdomyosarcoma |
| D012509 | Sarcoma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| During surgery (Day 0), based on intraoperative and postoperative pathology reports finalized within 7 days |