Multiparametric Imaging in Multiple Myeloma

NCT02646085 — Phase 1, Completed, 10 participants, Yingbing Wang

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Registry	NCT02646085
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	10 (Estimated)
Sponsor	Yingbing Wang (Other)
Conditions	Multiple Myeloma
Interventions	C11 Methionine positron emission tomography (Drug)
Dates	start 2016-07-01, primary completion 2021-06-30, completion 2021-06-30, first posted 2016-01-05, last updated 2021-09-16
Locations	1 site in United States

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention	Experimental	Drug: 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.

C11 Methionine positron emission tomography (Drug), also known as L-methionine [C-11] methyl positron emission tomography: diagnostic positron emission tomography imaging after intravenous injection of C11 Methionine

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 40 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Massachusetts General Hospital	Boston, Massachusetts	United States

+Publications

Results publication: 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 36382911