Imaging in MGUS, SMM and MM
Condition: Multiple Myeloma; Smoldering Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma; Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance
Intervention: 18-NaF PET; DCE-MRI; 18-FDG PET/CT
Intervention description: The patient will receive 5mCi of F-18 NaF IV (intravenous) bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection.; An FDA (Food and Drug Administration) approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).; The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. The injection site will be evaluated pre- and post administration for any reaction (e.g. bleeding, hematoma, redness, or infection). Whole body (vertex to toes) static PET/CT imaging will be performed beginning at 1-hour, and again at 2-hours post injection.
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 18-FDG PET/CT; Abnormal Plasma Cells; Serum Free Light-Chain Abnormality; Serum M-Protein; DCE-MRI; Multiple Myeloma; Smoldering Multiple Myeloma; SMM; MM

Summary:

      Background:

      - Recent studies have shown that the premalignant conditions monoclonal gammopathy of
      undetermined significance (MGUS) and smoldering multiple myeloma (SMM) have a high risk of
      progressing to multiple myeloma (MM). There are currently no known effective treatments to
      prevent MGUS or SMM from developing into MM, and there are no known tests for determining
      whether an individual with MGUS or SMM will develop MM. Researchers are investigating new and
      improved imaging techniques that may be able to better detect the progression of MGUS or SMM
      into MM.

      Objectives:

        -  To compare the results of three imaging techniques in individuals with MGUS, SMM, and
           MM.

        -  To correlate the information from the imaging studies with established clinical markers
           of progression from MGUS/SMM to MM.

      Eligibility:

      - Individuals at least 18 years of age who have been diagnosed with monoclonal gammopathy of
      undetermined significance, smoldering multiple myeloma, or multiple myeloma.

      Design:

        -  Participants will be screened with a physical examination and medical history, and will
           provide baseline blood, urine, and bone marrow samples before beginning the imaging
           studies.

        -  Participants will have three imaging studies on separate days: a standard
           18-fludeoxyglucose positron emission tomography/computed tomography scan (18-FDG
           PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT),
           and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).

        -  Participants will be closely monitored during each scan, and will provide additional
           blood samples before and after the scans.

        -  Participants may provide additional blood, urine, tissue, and bone marrow samples for
           optional research studies.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Diagnosis of MGUS, SMM and MM will be made in accordance with the clinical diagnostic
             criteria set forth by the International Myeloma Working Group.2. The diagnoses will be
             confirmed by laboratory tests, serum/urine protein electrophoresis, immunofixation and
             light-chain assays, a skeletal survey, or immunohistochemistry analyses of the bone
             marrow biopsy, or a combination of these.

          -  Age greater than or equal to 18 years.

          -  ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.

          -  The patient must be competent to sign an informed consent form.

          -  Creatinine less than 2.5 ULN or eGFR (estimated glomerular filtration rate) greater
             than 30

        EXCLUSION CRITERIA:

          -  A medical history of other malignancy (apart from basal cell carcinoma of the skin or
             in situ cervical carcinoma; also, for MM patients this does not include MM) except if
             the patient has been free of symptoms and without active therapy during at least the
             previous 5 years.

          -  Female subject is pregnant or breast-feeding.