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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel Lymph Node Biopsy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel Lymph Node Biopsy | Procedure |
| ||
| indocyanine green (ICG) |
| Measure | Description | Time Frame |
|---|---|---|
| % of Patients in Whom a Sentinel Lymph Node is Identified | These percentages will be compared using a non-inferiority comparison for matched pair data. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Heaton, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States | ||
| St. Jude's Children's Research Hospital |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2019 |
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| Drug |
|
| Memphis |
| Tennessee |
| 38105 |
| United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | N/A - data were not collected | Posted | 1 year |
|
|
up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 0 | 6 | 0 | 6 | 0 | 6 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neeta Pandit-Taskar, MD | Memorial Sloan Kettering Cancer Center | 1-833-MSK-KIDS | pandit-n@mskcc.org |
| Sep 7, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D021701 | Sentinel Lymph Node Biopsy |
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|