NCT02646085

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Jul 2016

Typical duration for phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

5 years

First QC Date

December 28, 2015

Last Update Submit

September 15, 2021

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

C11 Methionine positron emission tomographyDRUG

diagnostic positron emission tomography imaging after intravenous injection of C11 Methionine

Also known as: L-methionine [C-11] methyl positron emission tomography
Intervention

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Wang Y, Yee A, Bernstein Z, O'Donnell E, Raje N, Mahmood U. Carbon-11-Labeled Methionine PET/CT in Patients With FDG-Occult Multiple Myeloma: A Prospective Pilot Study. AJR Am J Roentgenol. 2023 Apr;220(4):578-579. doi: 10.2214/AJR.22.28560. Epub 2022 Nov 16.

    PMID: 36382911DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Methionine3-alpha-Hydroxysteroid Dehydrogenase (B-Specific)

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino Acids, EssentialAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Neutral3-Hydroxysteroid DehydrogenasesHydroxysteroid DehydrogenasesAlcohol OxidoreductasesOxidoreductasesEnzymesEnzymes and CoenzymesNAD (+) and NADP (+) Dependent Alcohol Oxidoreductases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Radiologist

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 5, 2016

Study Start

July 1, 2016

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

US(1)