Trial Outcomes & Findings for MRI for Non-invasive Evaluation of Brain Stress (NCT NCT01898650)

Results Overview

To be measured with both oxygen extraction fraction and arterial spin labeling to measure blood flow.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

during the single MRI scan, approximately 30 - 45 minutes

Results posted on

2023-05-23

Patients were recruited from the beginning of 2013 (anticipated date) until September 2014 (anticipated date).

Participant milestones
Measure	Craniofacial Abnormalities Subjects with craniosynostosis or other craniofacial abnormalities associated with ICP who will undergo an MR scan. MR scan
Overall Study STARTED	12
Overall Study Scanned	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Craniofacial Abnormalities Subjects with craniosynostosis or other craniofacial abnormalities associated with ICP who will undergo an MR scan. MR scan
Overall Study the subject would not lie still for imaging	1

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Craniofacial Abnormalities n=12 Participants Subjects with craniosynostosis or other craniofacial abnormalities associated with ICP who will undergo an MR scan. MR scan
Age, Categorical <=18 years	12 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants
Sex: Female, Male Female	4 Participants n=12 Participants
Sex: Female, Male Male	8 Participants n=12 Participants
Region of Enrollment United States	12 Participants n=12 Participants

Timeframe: during the single MRI scan, approximately 30 - 45 minutes

To be measured with both oxygen extraction fraction and arterial spin labeling to measure blood flow.

Outcome measures
Measure	Craniofacial Abnormalities n=6 Participants Subjects with craniosynostosis or other craniofacial abnormalities associated with ICP who will undergo an MR scan. MR scan
Blood Flow and Perfusion	26.8 ml/min/100g Standard Deviation 5.6

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Washington University School of Medicine

Phone: 13144544005