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Trial Title:
Developing a Whole-body MRI and Diffusion-weighted Imaging State-of-the-art Protocol: a Pilot Study
NCT ID:
NCT06533189
Condition:
Whole Body Imaging
Cancer
Genetic Predisposition
Conditions: Official terms:
Disease Susceptibility
Genetic Predisposition to Disease
Conditions: Keywords:
MRI
Whole Body MRI
Genetic Predisposition to Cancer
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Enhanced Diffusion Software
Description:
Application of specific sequences with the use of Enhanced Diffusion Software during
Patient MRI
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
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Radiologia
Address:
City:
Roma
Zip:
00168
Country:
Italy
Facility:
Name:
Advanced Radiology Center
Address:
City:
Rome
Zip:
00168
Country:
Italy
Start date:
September 1, 2024
Completion date:
February 28, 2026
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Collaborator:
Agency:
GE Healthcare
Agency class:
Industry
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06533189
