Ignite Creation Date:
2024-05-05 @ 9:55 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00992745
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2009-10-08
Brief Title:
A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer
Sponsor:
Molecular Insight Pharmaceuticals Inc
Organization:
Molecular Insight Pharmaceuticals Inc
Study Overview
Official Title:
A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2011-10
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 an open-label study comparing the imaging characteristics of 123-I-MIP-1072 and ProstaScint 111-In-capromab pendetidein patients with metastatic prostate cancer Eligible patients will receive a dose of 123-I-MIP-1072 and have imaging studies and safety assessments physical examination vital signs electrocardiogram clinical laboratory tests performed during the subsequent 24 hours Two weeks later patients will return for additional safety assessments and will receive ProstaScint if they dont already have a pre-existing ProstaScint scan Final assessments will be performed two weeks after the ProstaScint scan unless there is a difference between the 123-I-MIP-1072 and ProstaScint scans If this is the case another dose of 123-I-MIP-1072 will be given 12 weeks later and imaging studies repeated
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