Ignite Creation Date:
2024-05-06 @ 7:15 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02509585
Status:
TERMINATED
Last Update Posted:
2019-02-11
First Post:
2015-07-24
Brief Title:
A Trial of Comparing the Pathology Status of Lymphoseek-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection
Sponsor:
Cardinal Health 414 LLC
Organization:
Cardinal Health 414 LLC
Study Overview
Official Title:
A Prospective Open-Label Trial of Comparing the Pathology Status of Lymphoseek-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective open-label within-patient multi-center study of Lymphoseek in the detection of lymph nodes in subjects with known cancer of the cervix All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi 74 MBq Tc 99m
Detailed Description:
None
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