Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089310
Status:
COMPLETED
Last Update Posted:
2016-06-30
First Post:
2004-08-04
Brief Title:
Sentinel Lymph Node Mapping in Detecting Cancer That Has Spread to Lymph Nodes in Patients With Non-Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Intraoperative Sentinel Node Mapping In Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Diagnostic procedures such as sentinel lymph node mapping may improve the ability to detect cancer that has spread to the lymph nodes
PURPOSE This clinical trial is studying how well sentinel lymph node mapping works in detecting cancer that has spread to the lymph nodes in patients who are undergoing surgery for stage I non-small cell lung cancer
PURPOSE This clinical trial is studying how well sentinel lymph node mapping works in detecting cancer that has spread to the lymph nodes in patients who are undergoing surgery for stage I non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility and accuracy of intraoperative sentinel lymph node mapping using technetium Tc 99 sulfur colloid in patients with stage I non-small cell lung cancer
Determine the percentage of patients in which at least 1 positive sentinel lymph node is identified using this procedure
Determine the percentage of patients undergoing this procedure who are found to have positive sentinel lymph nodes with no metastases in other intrathoracic lymph nodes
Secondary
Determine the percentage of patients undergoing this procedure whose disease stage is upgraded due to detection of micrometastases in sentinel lymph nodes
Correlate the presence of micrometastases in sentinel lymph nodes with survival in patients undergoing this procedure
Determine the percentage of patients undergoing this procedure with skip metastases pattern NZ sentinel lymph nodes
OUTLINE This is a multicenter study
Patients receive an intraoperative intratumoral injection of technetium Tc 99 sulfur colloid At least 10 minutes later patients undergo sentinel lymph node mapping using a gamma probe Patients then undergo sentinel lymph node dissection and tumor resection Pathology assays are performed using sentinel lymph node tissue including hematoxylin and eosin staining serial sections and immunohistochemistry using the AE1AE3PCK2b cytokeratin antibody
Patients are followed every 6 months for 2 years and then annually thereafter
Primary
Determine the feasibility and accuracy of intraoperative sentinel lymph node mapping using technetium Tc 99 sulfur colloid in patients with stage I non-small cell lung cancer
Determine the percentage of patients in which at least 1 positive sentinel lymph node is identified using this procedure
Determine the percentage of patients undergoing this procedure who are found to have positive sentinel lymph nodes with no metastases in other intrathoracic lymph nodes
Secondary
Determine the percentage of patients undergoing this procedure whose disease stage is upgraded due to detection of micrometastases in sentinel lymph nodes
Correlate the presence of micrometastases in sentinel lymph nodes with survival in patients undergoing this procedure
Determine the percentage of patients undergoing this procedure with skip metastases pattern NZ sentinel lymph nodes
OUTLINE This is a multicenter study
Patients receive an intraoperative intratumoral injection of technetium Tc 99 sulfur colloid At least 10 minutes later patients undergo sentinel lymph node mapping using a gamma probe Patients then undergo sentinel lymph node dissection and tumor resection Pathology assays are performed using sentinel lymph node tissue including hematoxylin and eosin staining serial sections and immunohistochemistry using the AE1AE3PCK2b cytokeratin antibody
Patients are followed every 6 months for 2 years and then annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CALGB-140203 | None | None | None |
| CDR0000378197 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |