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A Phase 2 Diagnostic Imaging Study With 99mTc-MIP-1404 in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01667536
First received: August 13, 2012
Last updated: February 29, 2016
Last verified: February 2016
Results First Received: December 15, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Prostate Cancer
Intervention: Drug: Drug: 99mTc-MIP-1404

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Drug: 99mTc-MIP-1404

20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404

Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404


Participant Flow:   Overall Study
    Drug: 99mTc-MIP-1404  
STARTED     105  
COMPLETED     105 [1]
NOT COMPLETED     0  
[1] 105 subjects comprised the safety popn, defined as all subjects who received an MIP-1404 injection.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Drug: 99mTc-MIP-1404

20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404

Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404


Baseline Measures
    Drug: 99mTc-MIP-1404  
Number of Participants  
[units: participants]
  105  
Age  
[units: years]
Mean (Standard Deviation)
  63.2  (6.8)  
Gender  
[units: participants]
 
Female     0  
Male     105  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.   [ Time Frame: Within 3-6 hours of dosing SPECT/CT images will be taken ]

2.  Primary:   Adverse Events   [ Time Frame: approximately 21 days [from Day 0 (study drug dosing) to Day 21] ]

3.  Secondary:   Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes   [ Time Frame: Within 3-6 hours of dosing SPECT/CT images will be taken ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Director, Clinical Science Communications
Organization: Progenics Pharmaceuticals, Inc.
phone: 914 784-1825
e-mail: vdipippo@progenics.com


Publications:
American Cancer Society, Inc., Surveillance Research; Cancer Facts & Figures, 2012

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01667536     History of Changes
Other Study ID Numbers: MIP-1404-201
Study First Received: August 13, 2012
Results First Received: December 15, 2015
Last Updated: February 29, 2016
Health Authority: United States: Food and Drug Administration