S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma

April 21, 2017 updated by: Southwest Oncology Group

A Prospective Observational Study of Patients With Solitary Plasmacytoma Using a Modified Staging System Supplemented by an MRI and Whole Body FDG-PET Scan

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36652-2144
        • Mobile Infirmary Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • Kansas
      • Salina, Kansas, United States, 67401
        • Tammy Walker Cancer Center at Salina Regional Health Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0942
        • University of Michigan Comprehensive Cancer Center
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, United States, 59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings, Montana, United States, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare
      • Billings, Montana, United States, 59107-5100
        • Billings Clinic Cancer Center
      • Billings, Montana, United States, 59107-7000
        • Deaconess Billings Clinic - Downtown
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, United States, 59701
        • St. James Community Hospital
      • Great Falls, Montana, United States, 59405
        • Big Sky Oncology
      • Great Falls, Montana, United States, 59405
        • Sletten Regional Cancer Institute at Benefis Healthcare
      • Helena, Montana, United States, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology
      • Missoula, Montana, United States, 59801
        • Community Medical Center
      • Missoula, Montana, United States, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, United States, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, United States, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Radiation Oncology
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital, Incorporated
      • Wilson, North Carolina, United States, 27893-3428
        • Wilson Medical Center
    • Wyoming
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed solitary plasmacytoma of 1 of the following types:

    • Solitary bone plasmacytoma
    • Extraosseus solitary plasmacytoma
  • Bone marrow plasmacytosis < 10% within the past 4 weeks

  • Low serum and/or urine M-protein meeting ≥ 1 of the following criteria:

    • Serum IgG < 3.5 g/dL
    • Serum IgA < 2.0 g/dL
    • Urine M-protein (kappa or lambda) < 1.0 g/24 hours
  • No lytic lesions on skeletal survey other than a single lesion associated with solitary plasmacytoma within the past 4 weeks

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Hemoglobin ≥ 10 g/dL* AND/OR
  • No hemoglobin 2 g/dL < lower limit of normal* (LLN) NOTE: *Patients with a history of hemoglobin < 10 g/dL AND/OR < 2 g/dL < LLN that has corrected or improved after epoetin alfa but requires continued treatment with epoetin alfa are not eligible

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: MRI and PET
Magnetic resonance imaging and positron emission tomography
Procedure: magnetic resonance imaging
magnetic resonance imaging (MRI)
Other Names:
  • MRI
Procedure: positron emission tomography
positron emission tomography (PET)
Other Names:
  • PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of patients misclassified as solitary plasmacytoma
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Janet S. Biermann, MD, University of Michigan Rogel Cancer Center
  • Study Chair: Andrzej J. Jakubowiak, MD, PhD, University of Michigan Rogel Cancer Center
  • Study Chair: Paul Okunieff, MD, James P. Wilmot Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

April 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

May 3, 2005

First Submitted That Met QC Criteria

May 3, 2005

First Posted (ESTIMATE)

May 4, 2005

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000426422
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0340 (OTHER: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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