Comparison Between Whole Body DWI and FDG PET/CT in Patients with Simptomatic Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Whole Body DWI Sequences As Compared with Standard FDG PET/CT in Patients with Simptomatic Multiple Myeloma
Overview
The primary objective is to evaluate the concordance of FDG PET/CT and total body DWI MRI sequences performed during staging and at the completion of therapy. Specifically, we will assess the positivity rates, both patient-based and lesion-based (total and by district), of the two methods during staging and at the completion of therapy. An interim analysis will be conducted comparing the two methods, followed by a final prognostic analysis.
Primary outcome measures
- positivity rate [Time frame: 33 months]
Eligibility criteria
Inclusion criteria
- • Patients with symptomatic myeloma in the staging phase or with suspected symptomatic myeloma in the diagnostic phase
- Patients who have signed the informed consent form
Exclusion criteria
- Patients simultaneously affected by other neoplastic diseases or with a history of other neoplasms in the previous 5 years
- Age < 18 years
- Women who are breastfeeding or pregnant
- Patients with metal implants or devices that constitute an absolute contraindication for MRI
- Patients with severe claustrophobia
- Patients with bone pain that prevents prolonged maintenance of the supine position
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Policlinico S.Orsola Malpighi — Bologna
Identifiers
NCT: NCT06659276 · IRCCS S.Orsola Malpighi