Pediatric Patients With Solid Tumors
Conditions
Keywords
indocyanine green fluorescent dye, Technetium lymphoscintigraphy, sentinel lymph node biopsy, 16-1003
Brief summary
This study is being done in patients that have tumors to find out how well sentinel lymph nodes (SLNs) can be found with a special dye called indocyanine green (ICG).
Interventions
PROCEDURESentinel Lymph Node Biopsy
DRUGindocyanine green (ICG)
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Years
Healthy volunteers
No
Inclusion criteria
* Patients \<30 years old with an extracoelomic solid tumor, diagnosis confirmed at the enrolling institution, requiring SLN biopsy * Women of childbearing potential must have a negative pregnancy test (urine or blood) pre-operatively as per the standard hospital policy. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. * Patients who are cleared for surgery
Exclusion criteria
* History of reaction to ICG, iodides, or technetium radiocolloid * Intracoelomic primary tumors or tumors expected to drain to an intracoelomic SLN * Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage * Patients unwilling or unable to sign informed consent * Women who are pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of Patients in Whom a Sentinel Lymph Node is Identified | 1 year | These percentages will be compared using a non-inferiority comparison for matched pair data. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sentinel Lymph Node Biopsy This is a single-center clinical trial to evaluate non-inferiority of ICG-guided SLN biopsy compared with the gold standard TcL-guided SLN biopsy in pediatric patients with solid tumors. Each patient will undergo TcL, consistent with the standard of care, but the surgeon will be blinded to the results preoperatively. Intraoperatively, ICG injection and transdermal lymphography will be used to identify the draining nodal basin and the position of the sentinel nodes. ICG transdermal lymphography will be considered successful if SLNs can be visualized on near-infrared imaging. After the transdermal lymphography results have been recorded, the surgeon will be unblinded to the TcL mapping.
Sentinel Lymph Node Biopsy
indocyanine green (ICG) | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Sentinel Lymph Node Biopsy |
|---|---|
| Age, Continuous | 15 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
% of Patients in Whom a Sentinel Lymph Node is Identified
These percentages will be compared using a non-inferiority comparison for matched pair data.
Time frame: 1 year
Population: N/A - data were not collected