Trial Outcomes & Findings for Magnetic Resonance Elastography in Infants (NCT NCT02201472)

NCT ID: NCT02201472

Last Updated: 2020-09-01

Results Overview

To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

12 months

Results posted on

2020-09-01

Participant Flow

Participant milestones

Participant milestones
Measure
MRI With MRE
Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device
Overall Study
STARTED
2
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
MRI With MRE
Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device
Overall Study
Lack of Efficacy
2

Baseline Characteristics

Magnetic Resonance Elastography in Infants

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 12 months

Population: There were too few eligible candidates that clinically would benefit enough to justify the potential risk of being removed from the unit and undergoing MRE in a Radiology department scanner, so the study was terminated with only 2 patients enrolled.

To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population.

Outcome measures

Outcome data not reported

Adverse Events

MRI With MRE

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. Stephanie Merhar

Cincinnati Children's Hospital

Phone: 513-803-5180

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place