Trial Outcomes & Findings for PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404 (NCT NCT01540513)

Last Updated: 2019-12-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

24- and 48 hours post injection

Results posted on

2019-12-02

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	I124-NM404 Brain Metastases or GBM Imaging n=12 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	43.9 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24- and 48 hours post injection

Population: Of 12 subjects, only 8 had evaluable data.

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.

Outcome measures

Outcome measures
Measure	I124-NM404 Brain Metastases or GBM Imaging n=8 Participants 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.
Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake 24 hours	8.25 Ratio of PET SUV Standard Deviation 4.16
Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake 48 hours	8.75 Ratio of PET SUV Standard Deviation 3.60

PRIMARY outcome

Timeframe: 24- and 48 hours post injection

Population: Of 12 participants, 8 had evaluable TBR data.

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.

Outcome measures

Outcome measures
Measure	I124-NM404 Brain Metastases or GBM Imaging n=8 Participants 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.
Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors 24 hours	9.32 Ratio of PET SUV Standard Deviation 4.33
Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors 48 hours	10.04 Ratio of PET SUV Standard Deviation 3.15

PRIMARY outcome

Timeframe: 24- and 48 hours post injection

Population: Of 12 participants, 8 had evaluable TBR data.

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.

Outcome measures

Outcome measures
Measure	I124-NM404 Brain Metastases or GBM Imaging n=8 Participants 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.
Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake 24 hours	2.86 Ratio of PET SUV Standard Deviation 1.77
Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake 48 hours	2.93 Ratio of PET SUV Standard Deviation 2.07

PRIMARY outcome

Timeframe: 24- and 48 hours post injection

Population: Of 12 participants, 8 had evaluable tumor to blood pool ratio data.

Outcome measures

Outcome measures
Measure	I124-NM404 Brain Metastases or GBM Imaging n=8 Participants 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.
Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors 24 hours	3.35 Ratio of PET SUV Standard Deviation 1.75
Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors 48 hours	3.45 Ratio of PET SUV Standard Deviation 2.15

Adverse Events

I124-NM404 Brain Metastases or GBM Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lance Hall

University of Wisconsin Carbone Cancer Center

Phone: 608-263-5585

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place