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Trial record 23 of 179 for:    Phospholipids

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

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ClinicalTrials.gov Identifier: NCT01540513
Recruitment Status : Completed
First Posted : February 28, 2012
Results First Posted : December 11, 2017
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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
Enrollment 12
Recruitment Details Participants were enrolled from March 2012 to September 2014 at the University of Wisconsin Hospital and Clinics.
Pre-assignment Details  
Arm/Group Title I124-NM404 Brain Metastases or GBM Imaging
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title I124-NM404 Brain Metastases or GBM Imaging
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  91.7%
>=65 years
1
   8.3%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
43.9
(23 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
12
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
 100.0%
1.Primary Outcome
Title Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake
Hide Description TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24- and 48 hours post injection.
Time Frame 24- and 48 hours post injection
Hide Outcome Measure Data
Hide Analysis Population Description
Of 12 subjects, only 8 had evaluable data.
Arm/Group Title I124-NM404 Brain Metastases or GBM Imaging
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Ratio of PET SUV
24 hours 8.25  (4.16)
48 hours 8.75  (3.60)
2.Primary Outcome
Title Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors
Hide Description TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24-, and 48 hours post injection.
Time Frame 24- and 48 hours post injection
Hide Outcome Measure Data
Hide Analysis Population Description
Of 12 participants, 8 had evaluable TBR data.
Arm/Group Title I124-NM404 Brain Metastases or GBM Imaging
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Ratio of PET SUV
24 hours 9.32  (4.33)
48 hours 10.04  (3.15)
3.Primary Outcome
Title Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake
Hide Description Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24- and 48 hours post injection.
Time Frame 24- and 48 hours post injection
Hide Outcome Measure Data
Hide Analysis Population Description
Of 12 participants, 8 had evaluable TBR data.
Arm/Group Title I124-NM404 Brain Metastases or GBM Imaging
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Ratio of PET SUV
24 hours 2.86  (1.77)
48 hours 2.93  (2.07)
4.Primary Outcome
Title Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors
Hide Description Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24-, and 48 hours post injection.
Time Frame 24- and 48 hours post injection
Hide Outcome Measure Data
Hide Analysis Population Description
Of 12 participants, 8 had evaluable tumor to blood pool ratio data.
Arm/Group Title I124-NM404 Brain Metastases or GBM Imaging
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Ratio of PET SUV
24 hours 3.35  (1.75)
48 hours 3.45  (2.15)
Time Frame Adverse event data were collected for up to 48 hours (until the time of the final scan).
Adverse Event Reporting Description Subjects are monitored for adverse events (AEs) by the research team and reported by the principle investigator or co-investigators. Subjects are observed during the injection of 124I-NM404 and for 30 minutes after injection. Subjects are also monitored at each PET/CT scanning session. Approximately 2 – 4 weeks after injection of 124I-NM404, subjects were contacted by phone or other means and/or medical records were reviewed, if available, to assess for any AEs. AE data collection is complete.
 
Arm/Group Title I124-NM404 Brain Metastases or GBM Imaging
Hide Arm/Group Description

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.

All-Cause Mortality
I124-NM404 Brain Metastases or GBM Imaging
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
I124-NM404 Brain Metastases or GBM Imaging
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
I124-NM404 Brain Metastases or GBM Imaging
Affected / at Risk (%)
Total   0/12 (0.00%) 
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
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: March 15, 2018