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

NCT ID: NCT06659276

Last Updated: 2024-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2027-10-10

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with new diagnosis of symptomatic multiple myeloma

fdg pet/CT and Whole body MRI with DWI

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Cristina Nanni

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Policlinico S.Orsola Malpighi

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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CRISTINA NANNI, MD

Role: CONTACT

+390512143182

Facility Contacts

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CRISTINA NANNI, MD

Role: primary

+390512143182

Other Identifiers

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IRCCS S.Orsola Malpighi

Identifier Type: -

Identifier Source: org_study_id

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