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

NCT06533189 | Not Yet Recruiting

• 1 other identifier: 6171
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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

Conditions

Whole Body Imaging; Cancer; Genetic Predisposition

Keywords

MRI; Whole Body MRI; Genetic Predisposition to Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  18 months

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

  18 months

Interventions

Enhanced Diffusion Software DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• GE Healthcare: collaborator

Study Sites (2)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Radiologia

Roma, 00168, Italy

Location

Advanced Radiology Center

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Neoplasms; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Evis Sala

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evis Sala

CONTACT

+390630158637; evis.sala@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)