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

Developing a Whole-body Magnetic Resonance Imaging 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

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Genetic Predisposition; Whole Body Imaging
• Intervention / Treatment: Device: Enhanced Diffusion Software

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Evis Sala; Phone Number: +390630158637; Email: evis.sala@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Radiologia
  • Rome, Italy, 00168
    • Advanced Radiology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Oncologic patients (with multiple myeloma, lymphoma, melanoma and metastatic cancer, such as prostate, breast and gynecologic cancers. Another application of WB-MRI is the imaging of patients with certain cancer predisposition syndromes

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiologists' satisfaction of the quality of images	Radiologists' satisfaction of the quality of images after applying noise reduction methods, in terms of mean overall response rate ≥4 at the questionnaires' items	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of the de-noised WB-MRI in detecting lesions	Comparison of diagnostic accuracy for lesion detection after applying noise reduction methods with that of standard reference imaging modalities,	18 months
Diagnostic accuracy of the de-noised WB-MRI in detecting staging metastatic oncologic patients.	Comparison of diagnostic accuracy for staging neoplasms according to the reference staging system with that of standard reference imaging modalities.	18 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Evis Sala, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: MRI; Whole Body MRI; Genetic Predisposition to Cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: 6171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No