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Imaging Studies and the Development of Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01571726
Recruitment Status : Withdrawn
First Posted : April 5, 2012
Last Update Posted : December 16, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


- Multiple myeloma (MM) is a type of malignant blood cancer. It affects the plasma cells, which help produce antibodies and fight infection. MM is nearly always preceded by a pre-malignant state, monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). Currently, it is not possible to predict when someone with MGUS or SMM will develop MM. Also, the disease changes in those early states are not well understood. Researchers want to look at imaging studies of people with MGUS, SMM, and MM. They will study whether the growth of blood vessels can be used to predict disease progression.


- To use imaging studies to evaluate disease progression in multiple myeloma.


- Individuals at least 18 years of age who have MGUS, SMM, or newly diagnosed MM.


  • Participants will be screened with a physical exam and medical history. They will also have blood and urine tests, and provide bone marrow samples.
  • Participants will have positron emission tomography (PET) scans with the new contrast agent [18]F-Fluciclatide. The contrast agent is intended to show patterns of increased vessel growth in the bone marrow.
  • Participants will also have a magnetic resonance imaging (MRI) scan. This scan will be done according to standard procedures.
  • Researchers will compare these scans with blood tests and other clinical information to study disease progression of MGUS, SMM, and MM.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Smoldering Multiple Myeloma Monoclonal Gammopathy of Undetermined Significance Drug: Fluciclatide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Novel Imaging Modalities to Characterize Angiogenesis in the Bone Marrow Microenvironment in Multiple Myeloma (MM) and Its Precursor Disease
Study Start Date : March 27, 2012
Actual Primary Completion Date : April 23, 2014
Actual Study Completion Date : April 23, 2014

Intervention Details:
  • Drug: Fluciclatide

Primary Outcome Measures :
  1. To explore the distribution of 18F-Fluciclatide PET/CT in bone marrow microenvironment in patients with multiple myeloma and its precursor disease (MGUS and SMM) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Distribution of agent [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Diagnosis of MGUS, SMM and MM will be made in accordance with the clinical diagnostic criteria set forth by the International Myeloma Working Group. The diagnosis will be confirmed by the following diagnostic tests:

    • serum/urine protein electrophoresis
    • serum/urine immunofixation,
    • light-chain assays,
    • a skeletal survey, or
  • immunohistochemistry analyses of the bone marrow biopsy, or
  • a combination of these at the NIH

Note: Written results from institutions outside of NIH for the above tests will be accepted if available.

  • Age greater than or equal to 18 years.
  • ECOG performance status of 0-2.
  • The patient must be competent to sign an informed consent form.
  • Platelet count = or > 100,000. Subjects must weight <320lbs
  • Creatinine <2.5 times ULN or eGFR>30 ml/min/1.73m(2)


  • 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 3 years.
  • Patients with documented metastatic lesions from another type of malignancy will be excluded.
  • Female subject is pregnant or breast-feeding.
  • The subject has known allergy to gadolinium
  • The subject has contraindications to MRI

    • Subjects must weigh <136 kg (weight limit for scanner table).
    • Subjects cannot have pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01571726

Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Carl O Landgren, M.D. National Cancer Institute (NCI)
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT01571726    
Other Study ID Numbers: 120106
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: April 16, 2014
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
(18)-Fluciclatide PET/CT
Serum M-Protein
Percentage of Plasma Cells in the Bone Marrow
Ratio of Normal/Abnormal Percentage of Plasma Cells in the Bone Marrow
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Smoldering Multiple Myeloma
Neoplasms, Plasma Cell
Monoclonal Gammopathy of Undetermined Significance
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Precancerous Conditions