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

Not yet recruiting

• Conditions: Cancer; Genetic Predisposition; Whole Body Imaging

• Registration Number: NCT06533189
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Study Start: 2024-09-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiologists' satisfaction of the quality of images	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 Outcome Measures

Name	Time	Method
Diagnostic accuracy of the de-noised WB-MRI in detecting lesions	18 months	Comparison 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 months	Comparison of diagnostic accuracy for staging neoplasms according to the reference staging system with that of standard reference imaging modalities.

Trial Locations

Locations (2)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Radiologia; 🇮🇹 Roma, Italy

Advanced Radiology Center; 🇮🇹 Rome, Italy