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PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404

This study has been terminated.
(budget)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01540513
First Posted: February 28, 2012
Last Update Posted: December 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
Results First Submitted: August 17, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Glioblastoma Multiforme
Brain Metastases
Intervention: Drug: NM404

  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
Participants were enrolled from March 2012 to September 2014 at the University of Wisconsin Hospital and Clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
I124-NM404 Brain Metastases or GBM Imaging

Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.

Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days.


Participant Flow:   Overall Study
    I124-NM404 Brain Metastases or GBM Imaging
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  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
I124-NM404 Brain Metastases or GBM Imaging

Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.

Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days.


Baseline Measures
   I124-NM404 Brain Metastases or GBM Imaging 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      11  91.7% 
>=65 years      1   8.3% 
Age 
[Units: Years]
Mean (Full Range)
 43.9 
 (23 to 66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  33.3% 
Male      8  66.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      12 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      12 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   12 


  Outcome Measures
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1.  Primary:   Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake   [ Time Frame: 24- and 48 hours post injection ]

2.  Primary:   Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors   [ Time Frame: 24- and 48 hours post injection ]

3.  Primary:   Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake   [ Time Frame: 24- and 48 hours post injection ]

4.  Primary:   Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors   [ Time Frame: 24- and 48 hours post injection ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Lance Hall
Organization: University of Wisconsin Carbone Cancer Center
phone: 608-263-5585
e-mail: lhall@uwhealth.org



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01540513     History of Changes
Other Study ID Numbers: RO11360
First Submitted: February 14, 2012
First Posted: February 28, 2012
Results First Submitted: August 17, 2017
Results First Posted: December 11, 2017
Last Update Posted: December 11, 2017