Trial Outcomes & Findings for MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation (NCT NCT00659776)

NCT ID: NCT00659776

Last Updated: 2024-01-30

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

255 participants

Primary outcome timeframe

72 hours

Results posted on

2024-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: Inflammatory Lesions Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions.	Group 2: Vascular Lesions Subjects with vascular lesions
Overall Study STARTED	230	25
Overall Study Number of Lesions Gadolinium	145	0
Overall Study Number of Lesions Ferumoxytol	152	0
Overall Study Degree of Contrast Enhancement Gadolinium	128	0
Overall Study Degree of Contrast Enhancement Ferumoxytol	131	0
Overall Study Border Delineation Gadolinium	128	0
Overall Study Border Delineation Ferumoxytol	131	0
Overall Study Internal Morphology of Lesions Gadolinium	128	0
Overall Study Internal Morphology of Lesions Ferumoxytol	131	0
Overall Study COMPLETED	218	23
Overall Study NOT COMPLETED	12	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Inflammatory Lesions Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions.	Group 2: Vascular Lesions Subjects with vascular lesions	Group 3: Lymph Nodes Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
Overall Study Withdrawal by Subject	12	2	0

Baseline Characteristics

MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Inflammatory Lesions n=230 Participants Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions.	Group 2: Vascular Lesions n=25 Participants Subjects will include those with vascular CNS lesions such as ischemic stroke, TIA with suspected carotid embolic origin, or atherosclerotic or inflammatory vasculopathy involving the carotids (including diagnosed carotid stenosis \>50%), aorta and the arteries of the extremities or thrombosis of the intraabdominal, pelvic or extremity veins.	Group 3: Lymph Nodes Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.	Total n=255 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	184 Participants n=5 Participants	24 Participants n=7 Participants	—	208 Participants n=4 Participants
Age, Categorical >=65 years	46 Participants n=5 Participants	1 Participants n=7 Participants	—	47 Participants n=4 Participants
Age, Continuous	51.6 years STANDARD_DEVIATION 15.8 • n=5 Participants	61.4 years STANDARD_DEVIATION 9.6 • n=7 Participants	—	52.3 years STANDARD_DEVIATION 15.5 • n=4 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	14 Participants n=7 Participants	—	119 Participants n=4 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	11 Participants n=7 Participants	—	136 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	1 Participants n=7 Participants	—	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	213 Participants n=5 Participants	24 Participants n=7 Participants	—	237 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	—	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	—	2 Participants n=4 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	0 Participants n=7 Participants	—	6 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	—	3 Participants n=4 Participants
Race (NIH/OMB) White	213 Participants n=5 Participants	25 Participants n=7 Participants	—	238 Participants n=4 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	0 Participants n=7 Participants	—	4 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	—	2 Participants n=4 Participants
Region of Enrollment United States	230 participants n=5 Participants	25 participants n=7 Participants	—	255 participants n=4 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: Due to the study closing prematurely, the images for the 23 subjects in group 2 were collected but not processed for analysis, and no data were collected in group 3 for this measure.

Outcome measures

Outcome measures
Measure	Group 1: Inflammatory Lesions n=152 Participants Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions.	Group 2: Vascular Lesions Subjects will include those with vascular CNS lesions such as ischemic stroke, TIA with suspected carotid embolic origin, or atherosclerotic or inflammatory vasculopathy involving the carotids (including diagnosed carotid stenosis \>50%), aorta and the arteries of the extremities or thrombosis of the intraabdominal, pelvic or extremity veins.	Group 3: Lymph Nodes Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
Number of Lesions Gadolinium	1.8 Number of lesions Standard Deviation 1.17	—	—
Number of Lesions Ferumoxytol	1.9 Number of lesions Standard Deviation 1.09	—	—

PRIMARY outcome

Timeframe: 72 hours

Population: Due to the study closing prematurely, the images for the 23 subjects in group 2 were collected but not processed for analysis, and no data were collected in group 3 for this measure.

Scoring system for parameters: Degree of contrast enhancement (1=none, 2=moderate, 3=good, 4=excellent)

Outcome measures

Outcome measures
Measure	Group 1: Inflammatory Lesions n=131 Participants Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions.	Group 2: Vascular Lesions Subjects will include those with vascular CNS lesions such as ischemic stroke, TIA with suspected carotid embolic origin, or atherosclerotic or inflammatory vasculopathy involving the carotids (including diagnosed carotid stenosis \>50%), aorta and the arteries of the extremities or thrombosis of the intraabdominal, pelvic or extremity veins.	Group 3: Lymph Nodes Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
Degree of Contrast Enhancement Gadolinium	2.9 Score of contrast enhancement Standard Deviation 1.13	—	—
Degree of Contrast Enhancement Ferumoxytol	2.7 Score of contrast enhancement Standard Deviation 1.13	—	—

PRIMARY outcome

Timeframe: 72hrs

Population: Due to the study closing prematurely, the images for the 23 subjects in group 2 were collected but not processed for analysis, and no data were collected in group 3 for this measure.

The scoring parameters were: (1=none, 2=moderate, 3=good, 4=excellent).

Outcome measures

Outcome measures
Measure	Group 1: Inflammatory Lesions n=131 Participants Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions.	Group 2: Vascular Lesions Subjects will include those with vascular CNS lesions such as ischemic stroke, TIA with suspected carotid embolic origin, or atherosclerotic or inflammatory vasculopathy involving the carotids (including diagnosed carotid stenosis \>50%), aorta and the arteries of the extremities or thrombosis of the intraabdominal, pelvic or extremity veins.	Group 3: Lymph Nodes Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
Assessment of Border Delineation Gadolinium	3.2 Score assessment of border delineation Standard Deviation .87	—	—
Assessment of Border Delineation Ferumoxtyol	3.2 Score assessment of border delineation Standard Deviation .75	—	—

PRIMARY outcome

Timeframe: 72hrs

Population: Due to the study closing prematurely, the images for the 23 subjects in group 2 were collected but not processed for analysis, and no data were collected in group 3 for this measure.

The scoring parameters were: (1=poor, 2=moderate, 3=good).

Outcome measures

Outcome measures
Measure	Group 1: Inflammatory Lesions n=131 Lesion Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions.	Group 2: Vascular Lesions Subjects will include those with vascular CNS lesions such as ischemic stroke, TIA with suspected carotid embolic origin, or atherosclerotic or inflammatory vasculopathy involving the carotids (including diagnosed carotid stenosis \>50%), aorta and the arteries of the extremities or thrombosis of the intraabdominal, pelvic or extremity veins.	Group 3: Lymph Nodes Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
Internal Morphology of Lesions Gadolinium	2.4 Score of internal morphology of lesions Standard Deviation 1.04	—	—
Internal Morphology of Lesions Ferumoxytol	2.5 Score of internal morphology of lesions Standard Deviation .99	—	—

SECONDARY outcome

Timeframe: 72 hours

Population: Due to the study closing prematurely, we did not collect these data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Population: Of the 230 subjects enrolled in group 1, 12 withdrew or were taken of study prior to receiving ferumoxytol. The 218 subjects remaining were analyzed. Of the 25 subjects enrolled in group 2, 2 withdrew or were taken of study prior to receiving ferumoxyotol. The 23 subjects remaining were analyzed.

Number of serious adverse events attributable to ferumoxytol.

Outcome measures

Outcome measures
Measure	Group 1: Inflammatory Lesions n=218 Participants Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions.	Group 2: Vascular Lesions n=23 Participants Subjects will include those with vascular CNS lesions such as ischemic stroke, TIA with suspected carotid embolic origin, or atherosclerotic or inflammatory vasculopathy involving the carotids (including diagnosed carotid stenosis \>50%), aorta and the arteries of the extremities or thrombosis of the intraabdominal, pelvic or extremity veins.	Group 3: Lymph Nodes Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
Side Effects/Safety of Ferumoxytol When Given During MRI.	1 Number of serious AEs attributable to Fe	0 Number of serious AEs attributable to Fe	—

SECONDARY outcome

Timeframe: 6 months

Population: Due to the study closing prematurely, we did not enroll any subjects into this subgroup nor gather any data.

Outcome measures

Outcome data not reported

Adverse Events

Group 1: Inflammatory Lesions

Serious events: 39 serious events

Other events: 11 other events

Deaths: 1 deaths

Group 2: Vascular Lesions

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 3: Lymph Nodes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: Inflammatory Lesions n=218 participants at risk Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions. Ferumoxytol: Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2\* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials)	Group 2: Vascular Lesions n=23 participants at risk Subjects with vascular lesions Ferumoxytol: Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2\* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials)	Group 3: Lymph Nodes Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials. Ferumoxytol: Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2\* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials)
Gastrointestinal disorders Nausea	5.0% 11/218 • Number of events 11 • From time of ferumoxytol infusion through 30 days after ferumoxytol infusion. The SAEs reported here are all AEs of grades 3, and 4. The study was terminated early due to Covid and funding shortages. Therefore, subject enrollment was not met, and no subjects were enrolled in group 3.	8.7% 2/23 • Number of events 2 • From time of ferumoxytol infusion through 30 days after ferumoxytol infusion. The SAEs reported here are all AEs of grades 3, and 4. The study was terminated early due to Covid and funding shortages. Therefore, subject enrollment was not met, and no subjects were enrolled in group 3.	— 0/0 • From time of ferumoxytol infusion through 30 days after ferumoxytol infusion. The SAEs reported here are all AEs of grades 3, and 4. The study was terminated early due to Covid and funding shortages. Therefore, subject enrollment was not met, and no subjects were enrolled in group 3.

Additional Information

Amy Huddleston

Oregon Health and Science University

Phone: 503-494-2910

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place