Optimization of new MR protocols in clinical setting

Optimization of new MR protocols in clinical setting - Patient research MR (PTMR)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45021

Enrollment

1000

Registered

2016-01-07

Start date

2017-06-02

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alle aandoeningen waarvoor een klinische indicatie voor MR onderzoek Patients with a clinical indication for MR examination

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Clinical indication for MR examination Addendum 01 15/12/2015: diagnosis/clinical suspicion of cardiomyopathy Addendum 02 06/11/2017: Patients over 18 years old with a liver transplant, due to undergo routine liver biopsy or biopsy for suspected pathology after liver transplantation

Exclusion criteria

Exclusion criteria: All contra-indications for MR examinations (claustrophobia, cardiac pacemaker, implants not approved for MR at the employed field-strength, metal objects, etc) Incapable to undergo prolonged MR examination additonal to clinical MR examination (due to frailty of old age, general condition, ect). No informed consent for notification of study participation to the medical specialist . No informed consent for the work-up of incidental findings.;Addendum 01 15/12/2015: medical history of diabetes mellitus and/or medication use diabetes mellitus Addendum 02 06/11/2017: any contraindication to liver biopsy (coagulopathy, obstructed biliary tract with high risk bileleak, ascites etc)

Design outcomes

Primary

Measure	Time frame
The results of the additional MR acquisition methods may be evaluated for image quality, may be compared with those of conventional MR techniques, and/or results in clinical patients may be compared with the results (previously) obtained in healthy volunteers. The additional MR acquisition methods could be assessed for their incremental value, aspects for further optimization could be identified and these could be incorporated in the continuing process of development. Final step in this translation project is potential publication of the results obtained by application of the additional MR protocols in clinical patients. During this project more and better MR techniques and analysis tools will become available for research purposes and patient care. Main study parameters/endpoints will be described for each pilot study in an addendum. - Addendum 01 15/12/2015: myocardial triglyceride accumulation, native T1 relaxation times, ECV quantification, fibrosis/fat ratio. - Addendum 02 06/11/2017: LIF score, fat fraction, T1 times, T2 times.	—

Measure

Time frame

The results of the additional MR acquisition methods may be evaluated for image quality, may be compared with those of conventional MR techniques, and/or results in clinical patients may be compared with the results (previously) obtained in healthy volunteers. The additional MR acquisition methods could be assessed for their incremental value, aspects for further optimization could be identified and these could be incorporated in the continuing process of development. Final step in this translation project is potential publication of the results obtained by application of the additional MR protocols in clinical patients. During this project more and better MR techniques and analysis tools will become available for research purposes and patient care. Main study parameters/endpoints will be described for each pilot study in an addendum. - Addendum 01 15/12/2015: myocardial triglyceride accumulation, native T1 relaxation times, ECV quantification, fibrosis/fat ratio. - Addendum 02 06/11/2017: LIF score, fat fraction, T1 times, T2 times.

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Countries

Netherlands

Outcome results