NCT04441983

Brief Summary

  • 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.).

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

September 5, 2024

Status Verified

August 1, 2024

Enrollment Period

3.7 years

First QC Date

June 19, 2020

Last Update Submit

September 2, 2024

Conditions

Plantar Plate Tear

Outcome Measures

Primary Outcomes (1)

  • sensitivity / specificity

    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

Interventions

7 Tesla MRI of the footDIAGNOSTIC_TEST

7 Tesla MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have undergone a forefoot MRI for clinical indications (or previous study) will be enrolled

You may qualify if:

  • 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.

You may not qualify if:

  • previous foot surgery with metal in vivo
  • pregnancy or breast feeding
  • any MRI contra-indications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

Study Officials

  • Reto Sutter, MD

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Germann, MD

CONTACT

+41443863322christoph.germann@balgrist.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of radiology, medical doctor, principal investigator

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 22, 2020

Study Start

February 1, 2022

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

September 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)