Multiple MyelomaPhase 1NCT02646085
Multiparametric Imaging in Multiple Myeloma
A Phase 1 study testing C11 Methionine positron emission tomography in people with Multiple Myeloma, run by Yingbing Wang at 1 site in United States.
Trial summary
Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography imaging with intravenously injected C11 Methionine to detect viable lesions. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- C11 Methionine positron emission tomography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 30 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography imaging with intravenously injected C11 Methionine to detect viable lesions.
- Conditions
- Multiple Myeloma
- Being tested
- C11 Methionine positron emission tomography
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C11 Methionine positron emission tomographyDrug
Also called L-methionine [C-11] methyl positron emission tomography
diagnostic positron emission tomography imaging after intravenous injection of C11 Methionine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: C11 Methionine positron emission tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startJul 2016
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yingbing Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yingbing Wang, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646085
- Sponsor's protocol ID
- 2015P001579
- Status last verified
- Sep 2021
- First submitted
- 28 Dec 2015
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36382911
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Imaging in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02646085
- Acronym / sponsor ID
- 2015P001579
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yingbing WangUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography imaging with intravenously injected C11 Methionine to detect viable lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: C11 Methionine positron emission tomographyC11 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C11 Methionine positron emission tomographyAlso: L-methionine [C-11] methyl positron emission tomographydiagnostic positron emission tomography imaging after intravenous injection of C11 Methionine | Drug | Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 36382911Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C11 Methionine positron emission tomography in people with Multiple Myeloma, run by Yingbing Wang at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative measure of C11 Methionine uptake (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02646085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.