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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-10202 | Registry Identifier | NCI Clinical Trial Registration Program |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indocyanine green (ICG) | Experimental | Participants will receive Indocyanine green intraoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green | Drug | Given in to the vein (IV) |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful | The estimated percentage of ICG identification and its confidence interval (CI) based on the Pearson-Klopper method exact method will be calculated. | During surgery (Intraoperatively) |
| Percentage of patients with grade 3 or higher adverse events related to ICG use | 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. | From the time of ICG administration to 24 hours after surgery (post-surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Davidoff, MD | Contact | 888-226-4343 | referralinfo@stjude.org |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Davidoff, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lurie Children's Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| ClinicalTrials Open at St. Jude | View source |
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Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Data will be made available at the time of article publication.
Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Children's Hospital of Pittsburgh of UPMC | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
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| St. Jude Children's Research Hospital | Recruiting | Memphis | Tennessee | 38105 | United States |
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