Back to resultsMultiparametric Imaging in Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
C11 Methionine positron emission tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Multiple Myeloma with symptomatic bone or soft tissue disease
- Eastern Cooperative Oncology Group status 0 to 2
- Life expectance >= 12 weeks
- Ability to understand and willingness to sign informed consent
- Tissue sampling with genotype data planned within 3 months of C11 positron emission tomography (PET) imaging
Exclusion Criteria:
- Pregnant or breast feeding
- Claustrophobic reactions and unable to lie still on a bed inside the PET scanner for 60 minutes
- Research related radiation exposure exceeding 50 millisieverts
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
C11 Methionine positron emission tomography (PET/CT) studies will be performed as hybrid PET/CT examinations for attenuation correction and lesion localization. A bolus of 10 millicuries of C11 Methionine will be injected intravenously. Approximately 60 minutes following tracer injection, the patient will be positioned on a Siemens Biograph PET/CT scanner. A low milliampere CT of from the mid skull to mid thigh will be acquired first with while the patient is free breathing. PET will be acquired at 3 minutes per bed position using the 3D mode, approximately 6-7 bed positions. C11 Methionine PET/CT imaging will take less than 60 minutes.
Outcomes
Primary Outcome Measures
Quantitative measure of C11 Methionine uptake
Standardized uptake value (a semiquantitative, unit less measure of radioactivity normalized for injected activity and body weight) will be measured for individual C11 Methionine uptake abnormalities (defined as focally increased uptake higher than background levels in a similar tissue type). All abnormal uptake not in locations common for benign etiologies, such as fracture and degenerative change, will be measured.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02646085
Brief Title
Multiparametric Imaging in Multiple Myeloma
Official Title
Multiparametric Imaging in Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yingbing Wang
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography imaging with intravenously injected C11 Methionine to detect viable lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
C11 Methionine positron emission tomography (PET/CT) studies will be performed as hybrid PET/CT examinations for attenuation correction and lesion localization. A bolus of 10 millicuries of C11 Methionine will be injected intravenously. Approximately 60 minutes following tracer injection, the patient will be positioned on a Siemens Biograph PET/CT scanner. A low milliampere CT of from the mid skull to mid thigh will be acquired first with while the patient is free breathing. PET will be acquired at 3 minutes per bed position using the 3D mode, approximately 6-7 bed positions. C11 Methionine PET/CT imaging will take less than 60 minutes.
Intervention Type
Drug
Intervention Name(s)
C11 Methionine positron emission tomography
Other Intervention Name(s)
L-methionine [C-11] methyl positron emission tomography
Intervention Description
diagnostic positron emission tomography imaging after intravenous injection of C11 Methionine
Primary Outcome Measure Information:
Title
Quantitative measure of C11 Methionine uptake
Description
Standardized uptake value (a semiquantitative, unit less measure of radioactivity normalized for injected activity and body weight) will be measured for individual C11 Methionine uptake abnormalities (defined as focally increased uptake higher than background levels in a similar tissue type). All abnormal uptake not in locations common for benign etiologies, such as fracture and degenerative change, will be measured.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Multiple Myeloma with symptomatic bone or soft tissue disease
Eastern Cooperative Oncology Group status 0 to 2
Life expectance >= 12 weeks
Ability to understand and willingness to sign informed consent
Tissue sampling with genotype data planned within 3 months of C11 positron emission tomography (PET) imaging
Exclusion Criteria:
Pregnant or breast feeding
Claustrophobic reactions and unable to lie still on a bed inside the PET scanner for 60 minutes
Research related radiation exposure exceeding 50 millisieverts
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
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Multiparametric Imaging in Multiple Myeloma
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