Ignite Creation Date:
2024-05-06 @ 12:45 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01654874
Status:
COMPLETED
Last Update Posted:
2015-11-25
First Post:
2012-07-30
Brief Title:
99mTc-MIP-1404 for Imaging Prostate Cancer Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404
Sponsor:
Molecular Insight Pharmaceuticals Inc
Organization:
Molecular Insight Pharmaceuticals Inc
Study Overview
Official Title:
99mTc-MIP-1404 for Imaging Prostate Cancer Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404
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 trial is a single-blind cross-over design Up to three patients with confirmed metastatic prostate adenocarcinoma and up to three healthy volunteers will receive two doses of 200 3 mCi of intravenously administered 99mTc MIP 1404 preparation A or preparation B Whole-body planar scintigraphic images will be acquired at various time points on the day of study drug administration A pelvic SPECTCT image will be acquired on the day of study drug administration Blood will be collected for pharmacokinetic measurements following study drug administration Each participant will receive an initial study drug administration preparation A and a second study drug administration preparation B approximately 7 to 21 days later A final follow-up visit will occur approximately 2 - 3 weeks after the second study drug administration
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