NCT01633866

Brief Summary

The purpose of this study is to evaluate and optimize advances in radio frequency (RF) coil magnetic resonance imaging (MRI) technology at Cincinnati Children's Hospital Medical Center (CCHMC).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

12.9 years

First QC Date

June 21, 2012

Last Update Submit

December 11, 2024

Conditions

Keywords

Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events as measured by heating and comfort participant response

    Day 1

Secondary Outcomes (1)

  • MRI Image Quality

    2 Weeks Post MRI Scan

Study Arms (1)

Advances in Radio Frequency for MRI

advances in radio frequency (RF) coil magnetic resonance imaging (MRI)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy participants will be recruited by word-of-mouth, generally from within CCHMC.The healthy participants could include children of faculty or staff members of CCHMC.Because the healthy participants could include children of faculty or staff members, recruitment will be consistent with CCHMC Research Policy.Patients will be recruited at the time of their scheduled clinical scan.We are only using these participants to evaluate the safety and feasibility of the use of the new coils in our patient population.For this reason, we will not focus on the demographics of the participants.However, we will attempt to obtain a broad anatomic size range to match that of the patient population for which the coils were developed.

You may qualify if:

  • Healthy participants:
  • Male or Female
  • Thermally stable
  • Any age
  • Clinical patients:
  • Male or Female
  • Thermally stable
  • any age

You may not qualify if:

  • Healthy participants \& Clinical patients
  • Female participants who are pregnant or lactating
  • Subjects iwth standard contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Muscular Dystrophy, DuchenneMusculoskeletal Abnormalities

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCongenital Abnormalities

Study Officials

  • Charles Dumoulin, PhD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2012

First Posted

July 4, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

December 16, 2024

Record last verified: 2024-12

Locations