Whole Body DWI Sequences As Compared with Standard FDG PET/CT in Patients with Simptomatic Multiple Myeloma

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 site in 1 country83 target enrollmentSeptember 1, 2022

ConditionsMultiple Myeloma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Myeloma
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enrollment: 83
Locations: 1
Primary Endpoint: positivity rate
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2022

End Date

October 10, 2027

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Responsible Party

Principal Investigator

Cristina Nanni

IRCCS Azienda Ospedaliero-Universitaria di Bologna

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