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NCT02646085 Clinical Trial

Multiparametric Imaging in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
Multiparametric Imaging in Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02646085
Other study ID # 2015P001579
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 2016
Est. completion date June 30, 2021

Study information
Verified date September 2021
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography imaging with intravenously injected C11 Methionine to detect viable lesions.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• C11 Methionine positron emission tomography
diagnostic positron emission tomography imaging after intravenous injection of C11 Methionine

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Yingbing Wang

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 12 months
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