Multiparametric Imaging in Multiple Myeloma

September 15, 2021 updated by: Yingbing Wang
Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography imaging with intravenously injected C11 Methionine to detect viable lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
Drug: C11 Methionine positron emission tomography
diagnostic positron emission tomography imaging after intravenous injection of C11 Methionine
Other Names:
  • L-methionine [C-11] methyl positron emission tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative measure of C11 Methionine uptake
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yingbing Wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

December 28, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (Estimate)

January 5, 2016

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P001579

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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