- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04441983
Foot/Ankle at 7T MRI
February 7, 2023 updated by: Reto Sutter, MD, Balgrist University Hospital
High-Resolution MRI (7 Tesla) Findings of the Plantar Plate Compared With Current Clinical Standard Sequences (1.5 or 3 Tesla) and Surgical Reference Standard
- To evaluate standard clinical sequences for 7 Tesla MRI of the foot and/or ankle to improve detailed depiction of the complex anatomy of this region.
- To evaluate various pathologies of the foot and/or ankle (plantar plate tears, Morton neuroma, tendon tears, ligament tears etc.).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland, 8008
- Recruiting
- Balgrist University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who have undergone a forefoot MRI for clinical indications (or previous study) will be enrolled
Description
Inclusion Criteria:
- Informed consent as documented by signature (Appendix Informed Consent Form)
- at least 18 years old
- Study group: Patients with specific pathologies (i.e. Morton neuroma, tendon tears, plantar plate tears) as proven by 1,5 or 3T MRI or asymptomatic subjects (to look at the normal microanatomy of different structures, mainly the plantar plate)
- Control group: No evidence of the respective pathology.
Exclusion Criteria:
- previous foot surgery with metal in vivo
- pregnancy or breast feeding
- any MRI contra-indications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sensitivity / specificity
Time Frame: 2 years
|
The sensitivity/specificity for detection of various pathologies in the foot/ankle, for exampleMorton neuroma, plantar plate tears and tendon injuries at 7T MRI
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2022
Primary Completion (ANTICIPATED)
October 31, 2025
Study Completion (ANTICIPATED)
October 31, 2025
Study Registration Dates
First Submitted
June 19, 2020
First Submitted That Met QC Criteria
June 19, 2020
First Posted (ACTUAL)
June 22, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- R449
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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