Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06533189

Developing a Whole-body MRI and Diffusion-weighted Imaging State-of-the-art Protocol: a Pilot Study

Whole-body magnetic resonance imaging (WB-MRI) is a non-ionizing imaging method that can provide WB coverage using essential imaging contrasts with the possibility to include sequences focusing in specific body-regions as needed per case. WB-MRI is increasingly being used for the management of cancer patients, especially metastatic ones. An integral part of WB-MRI is becoming whole-body diffusion-weighted MRI (WB-DWI) which is a non-invasive tool used for staging and response evaluation in oncologic practice. WB-DWI is an inherently noisy technique, resulting in it accounting for more than 50% of the acquisition time of conventional whole-body MRI studies with overall duration at least 1-hour. Reducing acquisition times, without compromising image or diagnostic quality would facilitate the wider adoption of clinical WBDWI, reducing costs, and improving the patient experience

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Radiologia, Roma, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years old;
  • Patients with diagnosis of multiple myeloma, lymphoma, lung, prostate, breast, colorectal and gynecologic cancers;
  • Patients with genetic syndromes responsible for an increased predisposition to neoplasms (e.g. Li Fraumeni syndrome);
  • Signed written informed consent to personal data treatment for research purposes

Exclusion criteria

  • Age <18 years old;
  • Refusal to sign the written informed consent to personal data treatment for research purposes.

Treatment and study plan

Enhanced Diffusion Software

Device

Application of specific sequences with the use of Enhanced Diffusion Software during Patient MRI

Primary outcomes

  1. Radiologists' satisfaction of the quality of images

    Time frame: 18 months

    Radiologists' satisfaction of the quality of images after applying noise reduction methods, in terms of mean overall response rate ≥4 at the questionnaires' items

Secondary outcomes

  1. Diagnostic accuracy of the de-noised WB-MRI in detecting lesions

    Time frame: 18 months

    Comparison of diagnostic accuracy for lesion detection after applying noise reduction methods with that of standard reference imaging modalities,

  2. Diagnostic accuracy of the de-noised WB-MRI in detecting staging metastatic oncologic patients.

    Time frame: 18 months

    Comparison of diagnostic accuracy for staging neoplasms according to the reference staging system with that of standard reference imaging modalities.

Study contacts

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

Evis Sala

CONTACT

[email protected]

+390630158637

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • GE Healthcare

Registry information

Official study title

Developing a Whole-body Magnetic Resonance Imaging and Diffusion-weighted Imaging State-of-the-art Protocol, a Pilot Study

Acronym: WANDA

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

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.

Published trials that share one or more normalized conditions with this study.