Application of New Magnetic Resonance UTE Technique in Hip Joint Lesions

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05998720

Collaborator

(none)

150

Enrollment

Location

11.4

Anticipated Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Explore the imaging and quantitative monitoring of hip bone, cartilage and ligament by magnetic resonance UTE technology, combined with QCT and DXA technology, to provide a more accurate basis for clinical evaluation and treatment.

Condition or Disease	Intervention/Treatment	Phase
Hip Disease

Detailed Description

Osteoporosis is a systemic bone metabolism-related disease characterized by decreased bone mass per unit volume, increased bone fragility, decreased bone density, thinning of the bone cortex and changes in bone microstructure. It often occurs in the lumbar spine and hip joint. Femoral neck fracture is a common complication of hip osteoporosis, which seriously affects people's quality of life. UTE technology can clearly image and quantify human cortical bone and cancellous bone, and advanced UTE technology such as STAIR-UTE and UTE-MT have made some progress in the field of osteoporosis. The purpose of this study was to explore UTE technology for imaging and quantitative study of cortical bone, cancellous bone and cartilage of hip joint, and to find more accurate imaging methods for clinical evaluation of hip osteoporosis and other diseases.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Application of New Magnetic Resonance Technique-UTE in Hip Joint Lesions

Actual Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 13, 2024

Anticipated Study Completion Date :

Jun 13, 2024

Arms and Interventions

Arm	Intervention/Treatment
normal group There are no lesions on the hip.
abnormal group There are some lesions on the hip.

Outcome Measures

Primary Outcome Measures

proton density fat fraction (PDFF) [Baseline (before surgery)]
Magnetic resonance proton density fat fraction
T2 relaxation rate [Baseline (before surgery)]
R2*
Magnetization Transfer Ratio (MTR) [Baseline (before surgery)]
magnetization transfer ratio
T1rho [Baseline (before surgery)]
spin-lattice relaxation in the rotation ame

Secondary Outcome Measures

Subjective rating values [Baseline (before surgery)]
rating values

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with past or suspected osteoporosis and bone loss;
Patients with previous femoral neck fracture;
Patients with avascular necrosis of femoral head;
Hip osteoarthritis patients.

Exclusion Criteria:

Patients with metal implants in corresponding parts;
Claustrophobic.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiography department	Zhuhai	Guangdong	China	519000

Sponsors and Collaborators

Fifth Affiliated Hospital, Sun Yat-Sen University

Investigators

Study Director: Shaolin Li, Fifth Affiliated Hospital, Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fifth Affiliated Hospital, Sun Yat-Sen University

ClinicalTrials.gov Identifier:

NCT05998720

Other Study ID Numbers:

ZDWY.FSK.025

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 21, 2023