Ignite Creation Date:
2024-05-06 @ 12:36 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01615406
Status:
COMPLETED
Last Update Posted:
2015-11-25
First Post:
2012-06-04
Brief Title:
A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECTCT Imaging to Histology in Men With Prostate Cancer
Sponsor:
Molecular Insight Pharmaceuticals Inc
Organization:
Molecular Insight Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Pilot Comparison Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography SPECTCT Imaging to Histology in Men With Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2015-11
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 is a single arm open label study of up to 24 prostate cancer patients scheduled for prostatectomy andor 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 andor pelvic lymph node dissection PLND within two weeks of study drug dosing 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology
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