Multiple MyelomaPhase 2NCT03262389
Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma
A Phase 2 study testing Fludeoxyglucose PET CT, Sodium Acetate C11 PET CT and Fludeoxyglucose PET MRI in people with Multiple Myeloma, run by Michael C Roarke, MD at 1 site in United States.
Trial summary
Investigators are doing this study to determine which of four imaging techniques: Fludeoxyglucose Positron Emission Tomography (18 FDG PET) computerized tomography (CT), 18 FDG PET Magnetic resonance imaging (MRI), C-11 acetate PET CT, and C-11 acetate PET MRI) is the best test for finding sites of active myeloma… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Fludeoxyglucose PET CT, Sodium Acetate C11 PET CT and Fludeoxyglucose PET MRI
- 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
- 19 Sep 2017to 23 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients being staged for multiple myeloma as follows: new diagnosis, high risk smoldering multiple myeloma, relapsed as defined by investigator
- Patients who have undergone standard of care workup
- 300 pounds or less
- Can provide informed consent
- Scheduled for a clinically indicated F-18 FDG PET scan
- English speaking
Who cannot join
- Pregnant, breast feeding
- Concurrent active non-multiple myeloma malignancy
- Contraindication to PET MRI
- Previous Type I or Type II Diabetes mellitus or a fasting blood glucose >150 mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of F-18 FDG PET CT and PET MRI With C-11 Acetate PET CT and PET MRI in the Diagnosis of Active Multiple Myeloma Disease: a Pilot Study
Investigators are doing this study to determine which of four imaging techniques: Fludeoxyglucose Positron Emission Tomography (18 FDG PET) computerized tomography (CT), 18 FDG PET Magnetic resonance imaging (MRI), C-11 acetate PET CT, and C-11 acetate PET MRI) is the best test for finding sites of active myeloma disease.
Read the detailed description
Participants who are clinically scheduled to undergo F-18 FDG PET/CT myeloma evaluation will also undergo F-18 FDG PET/MRI, and C-11 acetate PET CT/MRI. On Day 1 of study, participants will undergo F-18 FDG PET/CT-MRI. F-18 FDG radiopharmaceutical is infused intravenously, followed by a 60 minute waiting uptake phase. After 60 minutes, participant will undergo PET/CT imaging for 30 minutes. At 90 minutes, participant will undergo PET/MRI imaging for 30 minutes. On Day 2 of study, participants will undergo C-11 PET/CT-MRI. C-11 radiopharmaceutical is infused intravenously, followed by a 10 minute uptake phase. After 10 minutes, participant will undergo PET/CT imaging for 30 minutes, followed by a 60 minute pause with the participant at rest. At the end of 60 minute pause, the participant is given the second C-11 acetate infusion, followed by a 10 minute waiting uptake phase. After 10 minutes, participant will undergo PET/MRI imaging for 30 minutes. On Day 3, study team member makes a phone call to participant for follow up.
- Conditions
- Multiple Myeloma
- Being tested
- Fludeoxyglucose PET CT, Sodium Acetate C11 PET CT, Fludeoxyglucose PET MRI, Sodium Acetate C11 PET MRI
- Keywords
- positron emission tomography (PET), computerized tomography (CT), Magnetic resonance imaging (MRI), Fludeoxyglucose (F-18 FDG), C-11 acetate
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludeoxyglucose PET CTDrug
Also called F-18 FDG PET CT
Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
Sodium Acetate C11 PET CTDrug
Also called C-11 acetate PET CT
Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
Fludeoxyglucose PET MRIDrug
Also called F-18 FDG PET MRI
Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
Sodium Acetate C11 PET MRIDrug
Also called C11 PET MRI
Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma Patients | Experimental | Participants will receive 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant will receive both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups. Receives: Drug: Fludeoxyglucose PET CT; Drug: Sodium Acetate C11 PET CT; Drug: Fludeoxyglucose PET MRI; Drug: Sodium Acetate C11 PET MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Multiple Myeloma Lesions Detected
The number of lesions detected in the scans will be averaged for each technique. Two techniques (scans) will be tested on Day 1 and two techniques (scans) will be tested on Day 2.
Measured: Day 1, Day 2
Secondary outcomes (1)
Visual Image Analysis of Detected Multiple Myeloma Lesions
The visual image analysis scale has a range of 0-4: (0 no uptake; 1 benign, 2 probably benign, 3 probably malignant, 4 malignant).
Measured: Approximately one month after Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start19 Sep 2017
- Primary completion23 Nov 2019
- Study completion23 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael C Roarke, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael C Roarke, MD, Mayo Clinic
- Investigators
- Michael C Roarke, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262389
- Sponsor's protocol ID
- 16-007867
- Status last verified
- Feb 2021
- First submitted
- 22 Aug 2017
- Last updated
- 16 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of F-18 FDG PET CT and PET MRI With C-11 Acetate PET CT and PET MRI in the Diagnosis of Active Multiple Myeloma Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT03262389
- Acronym / sponsor ID
- 16-007867
- Conditions
- Multiple Myeloma
- Keywords
- positron emission tomography (PET), computerized tomography (CT), Magnetic resonance imaging (MRI), Fludeoxyglucose (F-18 FDG), C-11 acetate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Michael C Roarke, MDUniversity, hospital or other
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 23 Nov 2019 (actual)
- Study completion
- 23 Nov 2019 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Posted 16 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators are doing this study to determine which of four imaging techniques: Fludeoxyglucose Positron Emission Tomography (18 FDG PET) computerized tomography (CT), 18 FDG PET Magnetic resonance imaging (MRI), C-11 acetate PET CT, and C-11 acetate PET MRI) is the best test for finding sites of active myeloma disease.
Detailed description
Participants who are clinically scheduled to undergo F-18 FDG PET/CT myeloma evaluation will also undergo F-18 FDG PET/MRI, and C-11 acetate PET CT/MRI. On Day 1 of study, participants will undergo F-18 FDG PET/CT-MRI. F-18 FDG radiopharmaceutical is infused intravenously, followed by a 60 minute waiting uptake phase. After 60 minutes, participant will undergo PET/CT imaging for 30 minutes. At 90 minutes, participant will undergo PET/MRI imaging for 30 minutes. On Day 2 of study, participants will undergo C-11 PET/CT-MRI. C-11 radiopharmaceutical is infused intravenously, followed by a 10 minute uptake phase. After 10 minutes, participant will undergo PET/CT imaging for 30 minutes, followed by a 60 minute pause with the participant at rest. At the end of 60 minute pause, the participant is given the second C-11 acetate infusion, followed by a 10 minute waiting uptake phase. After 10 minutes, participant will undergo PET/MRI imaging for 30 minutes. On Day 3, study team member makes a phone call to participant for follow up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma Patients | Experimental | Drug: Fludeoxyglucose PET CT, Drug: Sodium Acetate C11 PET CT, Drug: Fludeoxyglucose PET MRI, Drug: Sodium Acetate C11 PET MRIParticipants will receive 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant will receive both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients being staged for multiple myeloma as follows: new diagnosis, high risk smoldering multiple myeloma, relapsed as defined by investigator
- Patients who have undergone standard of care workup
- 300 pounds or less
- Can provide informed consent
- Scheduled for a clinically indicated F-18 FDG PET scan
Key exclusion criteria (4 listed)
- Pregnant, breast feeding
- Concurrent active non-multiple myeloma malignancy
- Contraindication to PET MRI
- Previous Type I or Type II Diabetes mellitus or a fasting blood glucose >150 mg/dl
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 |
|---|---|---|
| Fludeoxyglucose PET CTAlso: F-18 FDG PET CTRoute of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi). | Drug | Multiple Myeloma Patients |
| Sodium Acetate C11 PET CTAlso: C-11 acetate PET CTRoute of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq). | Drug | Multiple Myeloma Patients |
| Fludeoxyglucose PET MRIAlso: F-18 FDG PET MRIRoute of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi). | Drug | Multiple Myeloma Patients |
| Sodium Acetate C11 PET MRIAlso: C11 PET MRIRoute of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq). | Drug | Multiple Myeloma Patients |
Primary outcome
Mean Multiple Myeloma Lesions Detected
Time frame: Day 1, Day 2
The number of lesions detected in the scans will be averaged for each technique. Two techniques (scans) will be tested on Day 1 and two techniques (scans) will be tested on Day 2.
1 secondary outcome
Visual Image Analysis of Detected Multiple Myeloma Lesions
Time frame: Approximately one month after Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Michael C Roarke principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludeoxyglucose PET CT, Sodium Acetate C11 PET CT and Fludeoxyglucose PET MRI in people with Multiple Myeloma, run by Michael C Roarke, MD 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 6 inclusion and 4 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 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Multiple Myeloma Lesions Detected (time frame: Day 1, Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2021.