Multiparametric Imaging in Multiple Myeloma

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: C11 Methionine positron emission tomography

• Registration Number: NCT02646085
• Lead Sponsor: Yingbing Wang

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-31
• Study First Posted: 2016-01-05
• Study Start: 2016-07
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	C11 Methionine positron emission tomography	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.

Primary Outcome Measures

Name	Time	Method
Quantitative measure of C11 Methionine uptake	12 months	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States