Solid Tumor
Conditions
Keywords
Indocyanine Green, Sentinel Lymph Node Mapping, Pediatric, Young Adult
Brief summary
The purpose of the study is to find out the usefulness and safety of a dye called Indocyanine Green (ICG for short). This dye will be used to help the surgeon find lymph nodes draining solid tumors inside the abdomen that need to be removed. This may also help the surgeon to find if the cancer has moved to other lymph nodes outside of the known area. Primary Objectives * To determine the percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful at the time of retroperitoneal lymph node dissection for staging of visceral solid tumors. * To determine the percentage of patients with grade 3 or higher adverse events related to ICG use.
Detailed description
During surgery, participants will be given the dye to help the doctor see the lymph nodes to be removed. Pictures or a video of the procedure will be done. The number of lymph nodes removed will be recorded. After surgery, the lymph nodes will be examined. Participants will be followed for up to 24 hours after surgery to determine if there were any side effects from the dye.
Interventions
DRUGIndocyanine Green
Given in to the vein (IV)
Sponsors
St. Jude Children's Research Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 20 Years
Healthy volunteers
No
Inclusion criteria
* Any patient under the age of 21 years with visceral pediatric solid tumor suspected to be Wilms tumor or para-testicular rhabdomyosarcoma requiring retroperitoneal lymph node dissection.
Exclusion criteria
* Subjects with a history of iodide allergies. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. * Pregnant female. * Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful | During surgery (Intraoperatively) | The estimated percentage of ICG identification and its confidence interval (CI) based on the Pearson-Klopper method exact method will be calculated. |
| Percentage of patients with grade 3 or higher adverse events related to ICG use | From the time of ICG administration to 24 hours after surgery (post-surgery) | Adverse Events will be captured from the time of ICG administration to 24 hours post-surgery. Adverse Events will be graded by this scale: the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
Countries
United States
Contacts
CONTACTAndrew Davidoff, MD
PRINCIPAL_INVESTIGATORAndrew Davidoff, MD
St. Jude Children's Research Hospital
Outcome results
None listed