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Imaging Studies and the Development of Multiple Myeloma

NCT01571726 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-12-16

No results posted yet for this study

Summary

Background:

\- 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.

Objectives:

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

Eligibility:

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

Design:

* 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.

Conditions

  • Multiple Myeloma
  • Smoldering Multiple Myeloma
  • Monoclonal Gammopathy of Undetermined Significance

Interventions

DRUG

Fluciclatide

7mCi

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Carl O Landgren, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-27
Primary Completion
2014-04-23
Completion
2014-04-23

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01571726 on ClinicalTrials.gov