Ignite Creation Date:
2024-05-05 @ 11:12 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01279785
Status:
WITHDRAWN
Last Update Posted:
2015-11-25
First Post:
2011-01-18
Brief Title:
A Pilot Study of 123I-MIP-1072 SPECTCT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy
Sponsor:
Molecular Insight Pharmaceuticals Inc
Organization:
Molecular Insight Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Pilot Study of 123I-MIP-1072 Single Photon Emission Computed Tomography SPECTCT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy
Status:
WITHDRAWN
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Similar study to be completd once kit for new formulation becomes available
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 20 patients with prostate cancer scheduled for prostatectomy at the NIH Clinical Center 123I-MIP-1072 image data will be evaluated for visible uptake and compared with histopathology
Detailed Description:
This is an exploratory single arm open label pilot study evaluation of 123I-MIP-1072 intraprostatic uptake determination by SPECTCT imaging and optional CGCP imaging with histological confirmation of disease localization and staging Methodical evaluation of 123I-MIP-1072 in intraprostatic tumorous and non-tumours regions will provide important preliminary data upon which further clinical studies can be based The optional additional CGCP imaging was added because of its inherent potential for higher resolution scintigraphic detection of 123I-MIP-1072 localization This imaging feasibility data will provide important preliminary information for the use of CGCP imaging in prostate cancer
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