NCT04441983

Brief Summary

  • To evaluate standard clinical sequences for 7 Tesla MRI of the foot and extremities to improve detailed depiction of the complex anatomy of this region.
  • To evaluate various pathologies of the foot and extremities (plantar plate tears, Morton neuroma, tendon tears, ligament tears etc.).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
30mo left

Started Jun 2021

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jun 2021Dec 2028

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 year until next milestone

Study Start

First participant enrolled

June 25, 2021

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 16, 2026

Status Verified

October 1, 2025

Enrollment Period

7.4 years

First QC Date

June 19, 2020

Last Update Submit

July 14, 2026

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

Study Arms (1)

7T MRI of the foot

Diagnostic Test: 7 Tesla MRI of the foot

Interventions

7 Tesla MRI of the footDIAGNOSTIC_TEST

7 Tesla MRI

7T MRI of the foot

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/ extremities 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

    STUDY DIRECTOR

Central Study Contacts

Christoph Germann, MD

CONTACT

+41443863322christoph.germann@balgrist.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 22, 2020

Study Start

June 25, 2021

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

July 16, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)