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NCT Number: NCT05744102

Improve MRI Diagnosis

The main objective of the research is to compare by two blind evaluators new MRI techniques with routinely used sequences.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

"The main evaluation criterion will be the choice of the two (or three) evaluators as to the best sequence between the new sequence and the standard sequence.

The decision criterion for considering a new sequence as superior to the standard sequence will be based on two measures:

  • The proportion of patients for whom the new sequence was preferred, which must be greater than or equal to 75%;
  • Inter-observer agreement (Cohen's Kappa coefficient), which must be greater than or equal to 0.8; When these two criteria are met, the new sequence will be considered superior to the standard sequence"

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient
  • Patient who signed a consent to participate in the study
  • Affiliated patient or beneficiary of a social security scheme
  • Patient having an MRI scheduled as part of their care pathway
  • Absence of prohibition of participation in another research

Exclusion criteria

  • Patients under guardianship or curators
  • Pregnant or breastfeeding patients
  • Patients responding to a contraindication to performing an MRI
  • Patient under state medical aid (AME)
  • Adult patients protected by law

Treatment and study plan

MRI Image

Diagnostic Test

MRI sequences

Primary outcomes

  1. Image quality

    Time frame: 7 years

    The main evaluation criterion will be the choice of the two (or three) evaluators as to the best sequence between the new sequence and the standard sequence.

Secondary outcomes

  1. Acquisition period

    Time frame: 7 years

    Average acquisition time

  2. Apnea

    Time frame: 7 years

    Proportion of patients for whom apnea was requested.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-manuel DA-MOTA-FERREIRA, Radiologic Technologist

CONTACT

'[email protected]

(33) 01 45 59 35 26

Maïté LEWIN, MD, PHD

CONTACT

[email protected]

(33) 06 11 15 06 17

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Evaluation of Advanced and New MRI Techniques to Improve Patient Diagnosis

Acronym: DIAGIRM

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Feb 24, 2023
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.