Ignite Creation Date:
2024-05-06 @ 12:49 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01667536
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2012-08-13
Brief Title:
A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology
Sponsor:
Molecular Insight Pharmaceuticals Inc
Organization:
Molecular Insight Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy RP and Extended Pelvic Lymph Node Dissection EPLND Compared to Histopathology
Status:
COMPLETED
Status Verified Date:
2016-12
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:
This was a multicenter multi-reader open-label Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer Comparative performance characteristics between MIP 1404 imaging and MRI were also assessed as judged by histopathology results
Detailed Description:
This is a single arm open label study of approximately 100 high-risk prostate cancer patients scheduled for prostatectomy and extended pelvic lymph node dissection Patients receive a single IV dose of 99mTc-MIP-1404 study drug followed by SPECTCT scan 3-6 hours after injection As standard of care patients will undergo prostatectomy and extended pelvic lymph node dissection EPLND within three weeks of study drug dosing 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology
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