Multiple MyelomaNCT01880762
Evaluation of PET/MR and PET/CT Imaging for Bone Marrow Lesions
An observational study of Multiple Myeloma and Disease of the Marrow, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma, Disease of the Marrow, Osteoporosis
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with Multiple Myeloma and that are referred for PET CT imaging.
Who may be able to join
- subjects who are schedule for PET CT
- subjects that are diagnosed with Multiple Myeloma.
- Healthy subjects will be enrolled to optimize imaging techniques
- subjects 30 - 80 years of age
Who cannot join
- Exclusion criteria include all patients who are contraindicated for MR imaging in general.
- Contraindications include:
- electrical implants such as cardiac pacemakers or perfusion pumps
- ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
- ferromagnetic objects such as jewelry or metal clips in clothing
- pregnant subjects
- pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Center for Biomedical Imaging
New York, New York, 10016
About this study
Official title: Research 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 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.
Read the detailed description
Imaging of the pelvis and bilateral femora at 1.5 Tesla in a 30 minute research time "slots" at NYU-FPO MRI, Tisch Hospital, NYU Medical Center, Department of Radiology, HCC basement. This protocol utilizes routine, Dixon sequences and multi-echo MR "spectroscopic" sequences, allowing quantization of the fat water and trabecular moieties of marrow. The opposed phase portion of a Dixon sequence can aid differentiation between dense red marrow and a metastatic deposits by assaying for intravoxel fat. Diffusion sequences may also potentially improve specificity by assessing mobility of water in hypercellular and hypocellular portions of marrow, and will be added to the protocol if scan time permits.
The new sequences conform to FDA safety regulations regarding static magnetic field, time varying magnetic fields, specific absorption rate, and acoustic noise levels. However, since they have not been fully validated for diagnostic accuracy, the resulting images will be analyzed for research purposes only and will not be used in the patient's diagnostic assessment.
- Conditions
- Multiple Myeloma, Disease of the Marrow, Osteoporosis
- Keywords
- PET MR development and validation
- Medical subject headings
- Multiple Myeloma, Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
To Improve specificity of Multiple Myeloma using PET MR
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.
Measured: 2 years
Secondary outcomes (1)
Newly developed MRI imaging sequences
New imaging sequences developed will further improve specificity and assessment of marrow diseases in multiple myeloma patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra L Moore, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880762
- Sponsor's protocol ID
- S12-02920
- Status last verified
- Dec 2016
- First submitted
- 11 Mar 2013
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Evaluation of PET/MR and PET/CT Imaging for Bone Marrow Lesions
- ClinicalTrials.gov ID
- NCT01880762
- Acronym / sponsor ID
- S12-02920
- Conditions
- Multiple Myeloma, Disease of the Marrow, Osteoporosis
- Keywords
- PET MR development and validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Imaging of the pelvis and bilateral femora at 1.5 Tesla in a 30 minute research time "slots" at NYU-FPO MRI, Tisch Hospital, NYU Medical Center, Department of Radiology, HCC basement. This protocol utilizes routine, Dixon sequences and multi-echo MR "spectroscopic" sequences, allowing quantization of the fat water and trabecular moieties of marrow. The opposed phase portion of a Dixon sequence can aid differentiation between dense red marrow and a metastatic deposits by assaying for intravoxel fat. Diffusion sequences may also potentially improve specificity by assessing mobility of water in hypercellular and hypocellular portions of marrow, and will be added to the protocol if scan time permits.
The new sequences conform to FDA safety regulations regarding static magnetic field, time varying magnetic fields, specific absorption rate, and acoustic noise levels. However, since they have not been fully validated for diagnostic accuracy, the resulting images will be analyzed for research purposes only and will not be used in the patient's diagnostic assessment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Multiple Myeloma and that are referred for PET CT imaging.
Key inclusion criteria (4 listed)
- subjects who are schedule for PET CT
- subjects that are diagnosed with Multiple Myeloma.
- Healthy subjects will be enrolled to optimize imaging techniques
- subjects 30 - 80 years of age
Key exclusion criteria (7 listed)
- Exclusion criteria include all patients who are contraindicated for MR imaging in general.
- electrical implants such as cardiac pacemakers or perfusion pumps
- ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
- ferromagnetic objects such as jewelry or metal clips in clothing
- pregnant subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To Improve specificity of Multiple Myeloma using PET MR
Time frame: 2 years
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.
1 secondary outcome
Newly developed MRI imaging sequences
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra L Moore, MD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Disease of the Marrow, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Improve specificity of Multiple Myeloma using PET MR (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2016.