Ignite Creation Date:
2024-05-06 @ 8:54 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02857608
Status:
WITHDRAWN
Last Update Posted:
2017-03-15
First Post:
2016-08-02
Brief Title:
A Prospective Open-Label Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus
Sponsor:
Cardinal Health 414 LLC
Organization:
Cardinal Health 414 LLC
Study Overview
Official Title:
A Prospective Open-Label Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus
Status:
WITHDRAWN
Status Verified Date:
2017-03
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:
Prospective open-label within-subject multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus
Detailed Description:
Prospective open-label within-subject multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 05 millicurie mCi 185 MBq 99mTc
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