Comparison Between Whole Body DWI and FDG PET/CT in Patients with Simptomatic Multiple Myeloma

NCT06659276 | Recruiting

• 1 other identifier: IRCCS S.Orsola Malpighi
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

multiple myeloma, staging, therapy assessment, DWI, FDG PET CT

Outcome Measures

Primary Outcomes (1)

• positivity rate

  comparison per patient and per lesion between FDG PET CT and WB DWI

  33 months

Study Arms (1)

patients with new diagnosis of symptomatic multiple myeloma

fdg pet/CT and Whole body MRI with DWI

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

no additional info

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Policlinico S.Orsola Malpighi

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Driving Under the Influence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Criminal Behavior; Behavior; Dangerous Behavior

Central Study Contacts

CRISTINA NANNI, MD

CONTACT

+390512143182; cristina.nanni@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: September 1, 2022
• Primary Completion: November 1, 2024
• Study Completion (Estimated): October 10, 2027
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

IT (1)