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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06533189
Acronym
WANDA
Enrollment
120
Registered
2024-08-01
Start date
2024-09-01
Completion date
2026-02-28
Last updated
2024-08-01

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

Conditions

Cancer, Genetic Predisposition, Whole Body Imaging

Keywords

MRI, Whole Body MRI, Genetic Predisposition to Cancer

Brief summary

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

Interventions

DEVICEEnhanced Diffusion Software

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

Sponsors

GE Healthcare
CollaboratorINDUSTRY
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Radiologists' satisfaction of the quality of images18 monthsRadiologists' satisfaction of the quality of images after applying noise reduction methods, in terms of mean overall response rate ≥4 at the questionnaires' items

Secondary

MeasureTime frameDescription
Diagnostic accuracy of the de-noised WB-MRI in detecting lesions18 monthsComparison of diagnostic accuracy for lesion detection after applying noise reduction methods with that of standard reference imaging modalities,
Diagnostic accuracy of the de-noised WB-MRI in detecting staging metastatic oncologic patients.18 monthsComparison of diagnostic accuracy for staging neoplasms according to the reference staging system with that of standard reference imaging modalities.

Countries

Italy

Contacts

Primary ContactEvis Sala
evis.sala@policlinicogemelli.it+390630158637

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026