MRI Analysis and Degenerative Spine | NCT06163300

Studies
MRI Analysis and Degenerative Spine

NCT06163300

Sponsor

Universidade Nova de Lisboa

Status

Recruiting

Last Update Posted

Jan 30, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Spine Disease

Interventions

MRI advanced techniques

Countries

Portugal

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

Jan 2024

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

Jan 1, 2024Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

Sep 2026Estimated

First Submitted Date

Nov 30, 2023

First Submission Date that Met QC Criteria

Nov 30, 2023

First Posted Date

Dec 8, 2023Actual

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

Jan 26, 2024

Last Update Posted Date

Jan 30, 2024Actual

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

Analysis of MRI advanced techniques in degenerative spinal disease.

The main questions it aims to answer are:

Can we assess microstructural integrity of compressed nerve roots in degenerative spinal disease
What are the image biomarkers affected by disease
How they evolve with disease progression and treatment

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		Healthy volunteers	Diagnostic Test: MRI advanced techniques
Disease		Patients affected by disease	Diagnostic Test: MRI advanced techniques

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI advanced techniques	Diagnostic Test	Participants will be submitted to MRI studies at diagnosis, during disease evolution and after treatment. Data collected will be analysed by two different neuroradiologists using advanced techniques.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ODI - Oswestry Disability Index	Measured using the ODI scale (range 0 - 50)	18 months
Lumbar Pain Intensity	Measured using the Numeric Pain Rating Scale (range: 0 - 10 )	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 50 and 85 years
Diagnosis of spinal disease by clinical and imagiological criteria
More than 3 months duration of disease
Ability to give consent
Fluent portuguese speaker

Exclusion Criteria:

Previous spine surgery
Spinal instability
Neurological disease that might interfere with walking
Known orthopedic conditions that causes significant gait impairment
Dementia or development disorder with cognitive impairment
Inability to give consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with suspected diagnosis of the spinal disease in study and that meet the eligibility criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nuno A.R. Cristino, M.D.	Contact	+351919484946		nuno.cristino.ext@nms.unl.pt

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital da Luz Setúbal	Recruiting	Setúbal		2900-722	Portugal

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013122	Spinal Diseases

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided