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NCT01880762 · ClinicalTrials.gov registry record
Evaluation of PET/MR and PET/CT Imaging for Bone Marrow Lesions
A clinical trial, sponsored by NYU Langone Health.
- Completed
- Registry status
- 44
- Enrollment target
NCT01880762: Completed study, sponsored by NYU Langone Health.
NCT01880762 is a clinical trial that has completed, run by NYU Langone Health. The registered enrollment target is 44 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01880762 has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- 44 participants
- Enrollment target
Study Summary
Developing an MRI protocol at 1.5 T allowing quantification of the hematopoietic, fatty and trabecular moieties of marrow. An ideal protocol would differentiate red marrow from neoplastic cellular infiltration, and detect loss of trabecular bone. This study assesses the feasibility of a multiple gradient echo sequence for differentiation of water and fat constituents of marrow, combined with T2\* mapping to interrogate the trabecular component The investigators hypothesize that these techniques will allow better identification of lesion type than routine MR sequences, and can be used to quantitatively characterize myelomatous marrow replacement, with iliac crest biopsy (which is routinely performed in the diagnosis of myeloma) as gold standard. Fluoro-deoxyglucose (FDG)/PET CT imaging can detect FDG uptake in active myeloma and is obtained routinely for certain cohorts of patients with myeloma. PET/CT is commonly used in both initial whole body assessment and in monitoring remission. PET has been found to be about 59% sensitive and 75% specific for detection of myeloma . Myelomatous lesions are detected on MRI by the replacement of marrow fat. Routine MRI however is limited by scope/field of view, usually evaluating marrow in a single anatomic region (such as an extremity, the pelvis or spine). To assess the diffuse marrow involvement in MM, whole body MRI imaging potentiates near global assessment of the marrow, which aids in evaluating tumor burden, and may be useful in staging.
Primary Outcome
WHOLE BODY MRI/PET imaging for global assessment of the marrow in patients with MM. This will determine the feasibility of a multiple gradient echo sequence for differentiation of water and fat constituents of marrow, combined with T2\* mapping to interrogate the trabecular component which would allow for increased identification of lesion type than routine MR Sequences, and can be used to quantitatively characterize myelomatous marrow replacement with the current biopsy as gold standard.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-12 |
What the finished NCT01880762 record still lists
NCT01880762 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 44 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01880762 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01880762 about?
NCT01880762 is a clinical study titled "Evaluation of PET/MR and PET/CT Imaging for Bone Marrow Lesions". Developing an MRI protocol at 1.5 T allowing quantification of the hematopoietic, fatty and trabecular moieties of marrow. An ideal protocol would differentiate red marrow from neoplastic cellular infiltration, and detect loss of trabecular bone. This study assesses the feasibility of a multiple gra...
What is the current status of trial NCT01880762?
This trial is currently completed. The enrollment target is 44 participants. The study started on 2013-01. Estimated completion is 2016-12.
Who is sponsoring clinical trial NCT01880762?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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