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NCT01237054 · ClinicalTrials.gov registry record · Phase 2
Imaging in MGUS, SMM and MM
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT01237054: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01237054 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 31 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01237054, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study 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.
Interventions
- OTHER DCE-MRI
- DRUG 18-NaF PET
- DRUG 18-FDG PET/CT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-10-17 |
| Est. Completion | 2011-08-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01237054
The ClinicalTrials.gov registry entry for NCT01237054 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which DCE-MRI is the first listed.
NCT01237054 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01237054 about?
NCT01237054 is a clinical study titled "Imaging in MGUS, SMM and MM". 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 SM...
What is the current status of trial NCT01237054?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2010-10-17. Estimated completion is 2011-08-09.
What interventions are being tested in trial NCT01237054?
The interventions under investigation include: DCE-MRI (OTHER), 18-NaF PET (DRUG), 18-FDG PET/CT (DRUG).
Who is sponsoring clinical trial NCT01237054?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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