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Not yet recruitingNCT06533189WANDAUpdated Aug 1, 2024

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

An observational study in Whole Body Imaging, Cancer and Genetic Predisposition, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-01.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Whole Body Imaging
  • Cancer
  • Genetic Predisposition

Keywords

  • MRI
  • Whole Body MRI
  • Genetic Predisposition to Cancer
03

In context

Disease Susceptibility

141 studies on the registry are indexed under Disease Susceptibility; 31 are open to participants now.

This study's planned enrollment of 120 is below the median of 200 across 84 observational studies indexed under Disease Susceptibility.

Browse Disease Susceptibility studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

Exclusion Criteria:

  • Age \<18 years old;
  • Refusal to sign the written informed consent to personal data treatment for research purposes.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Interventions

  • DeviceEnhanced Diffusion Software

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

06

What researchers measure

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

    Time frame: 18 months

Secondary outcomes

  1. 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,

    Time frame: 18 months

  2. 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.

    Time frame: 18 months

07

Study locations

2 sites
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Radiologia
    Roma, 00168, Italy
  • Advanced Radiology Center
    Rome, 00168, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06533189
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
GE Healthcare
Responsible party
Sponsor
First posted
Aug 1, 2024
Start date
Sep 1, 2024 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Feb 28, 2026 (estimated)
Last update
Aug 1, 2024

Study contacts

Evis Sala
Contact
evis.sala@policlinicogemelli.it
+390630158637
Evis Sala
principal investigator · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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