Foot/Extremities at 7T MRI | NCT04441983

Studies
Foot/Extremities at 7T MRI

NCT04441983

Sponsor

Balgrist University Hospital

Status

Recruiting

Last Update Posted

Jul 10, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Plantar Plate Tear

Interventions

7 Tesla MRI of the foot

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2021Actual

Primary Completion Date

Nov 30, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Jun 19, 2020

First Submission Date that Met QC Criteria

Jun 19, 2020

First Posted Date

Jun 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2026

Last Update Posted Date

Jul 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
7T MRI of the foot	Other		Diagnostic Test: 7 Tesla MRI of the foot

Interventions

Name	Type	Description	Arm Group Labels	Other Names
7 Tesla MRI of the foot	Diagnostic Test	7 Tesla MRI	7T MRI of the foot

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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/ extremities surgery with metal in vivo
pregnancy or breast feeding
any MRI contra-indications

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christoph Germann, MD	Contact	+41443863322		christoph.germann@balgrist.ch

Overall Officials

Name	Affiliation	Role
Reto Sutter, MD	Balgrist University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Balgrist University Hospital	Recruiting	Zurich	Canton of Zurich	8008	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided