Tumor-Lymph Node Mapping
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-17
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any pediatric patient (under the age of 18 years) being treated at the University of Rochester Medical Center, Department of Surgery.
Diagnosed with pediatric solid tumor
Scheduled to undergo lymph node sampling as part of their clinical management.
Disqualifiers
Subjects with a history of iodide allergies.
Inability or unwillingness of research participant or parent/legal guardian to give written informed consent.
Currently pregnant.
Infants under 650 grams.
Trial population
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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
ICG (Indocyanine Green)
Diagnostic testLymphatic mapping
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Indocyanine Green (ICG) and KARL STORZ ICG Imaging System1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
BaselineOther outcomes
1
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.
Time frame
During surgery (Day 0), based on intraoperative and postoperative pathology reports finalized within 7 daysSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: