S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-04-30

Brief Summary

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RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) and fludeoxyglucose F 18 positron emission tomography (\^18FDG-PET) may help diagnose solitary plasmacytoma.

PURPOSE: This clinical trial is studying MRI and \^18FDG-PET to see how well they work in diagnosing patients with solitary plasmacytoma.

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Detailed Description

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OBJECTIVES:

* Determine the proportion of patients who are misclassified as true solitary plasmacytoma by MRI and whole-body fludeoxyglucose F 18 positron emission tomography as a supplement to imaging with skeletal survey.
* Determine the feasibility of accruing patients to this study.
* Determine, preliminarily, biological correlates and prognostic groups that may relate to progression to symptomatic disease in patients undergoing these imaging procedures.
* Correlate germline genetic polymorphisms with overall clinical course in patients undergoing these imaging procedures.

OUTLINE: This is a multicenter study.

Within 28 days after study entry, patients undergo gadolinium MRI of the head, spine, and pelvis (and other sites, if indicated). Patients then receive fludeoxyglucose F 18 IV followed 90 minutes later by whole-body positron emission tomography (\^18FDG-PET) OR whole-body CT scan/PET. Patients with a confirmed diagnosis of solitary plasmacytoma undergo MRI and \^18FDG-PET as above at 1 year and then annually for 10 years in the absence of disease progression (i.e., change of status to solitary plasmacytoma with active myeloma or biopsy confirmed stage IB or higher multiple myeloma).

After completion of study procedures, patients are followed every 6 months for 10 years.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study.

Conditions

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Multiple Myeloma Plasmacytoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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MRI and PET

Magnetic resonance imaging and positron emission tomography

Group Type OTHER

magnetic resonance imaging

Intervention Type PROCEDURE

magnetic resonance imaging (MRI)

positron emission tomography

Intervention Type PROCEDURE

positron emission tomography (PET)

Interventions

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magnetic resonance imaging

magnetic resonance imaging (MRI)

Intervention Type PROCEDURE

positron emission tomography

positron emission tomography (PET)

Intervention Type PROCEDURE

Other Intervention Names

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MRI PET

Eligibility Criteria

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Inclusion Criteria

Hepatic

* Not specified

Renal

* Calcium ≤ 10.5 mg/dL OR
* Calcium normal
* Creatinine ≤ 2 mg/dL

Other

* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or stage I or II cancer that is currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* No prior high-dose steroids except to relieve neurological compromise

Radiotherapy

* Prior localized radiotherapy for myeloma allowed
* Concurrent radiotherapy allowed

Surgery

* Prior surgery for myeloma allowed

Other

* No other prior therapy for myeloma
* Concurrent enrollment in protocol SWOG-S0309 (Myeloma Specimen Repository) allowed

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrzej J. Jakubowiak, MD, PhD

Role: STUDY_CHAIR

University of Michigan Rogel Cancer Center

Janet S. Biermann, MD

Role: STUDY_CHAIR

University of Michigan Rogel Cancer Center

Paul Okunieff, MD

Role: STUDY_CHAIR

James P. Wilmot Cancer Center

Locations

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Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, United States

Site Status