Multiple Myeloma
Conditions
Keywords
positron emission tomography (PET), computerized tomography (CT), Magnetic resonance imaging (MRI), Fludeoxyglucose (F-18 FDG), C-11 acetate
Brief 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 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.
Interventions
DRUGFludeoxyglucose PET CT
Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
DRUGSodium Acetate C11 PET CT
Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
DRUGFludeoxyglucose PET MRI
Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
DRUGSodium Acetate C11 PET MRI
Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
Sponsors
Michael C Roarke, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Multiple Myeloma Lesions Detected | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Image Analysis of Detected Multiple Myeloma Lesions | Approximately one month after Day 2 | The visual image analysis scale has a range of 0-4: (0 no uptake; 1 benign, 2 probably benign, 3 probably malignant, 4 malignant). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Multiple Myeloma (MM) Patients New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 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 received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.
Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).
Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq). | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Machine malfunction Day 1, no return Day 2 | 1 |
| Overall Study | opted out of PET/MR | 1 |
| Overall Study | opted out of the study once his clinical FDG PET CT was done. | 1 |
Baseline characteristics
| Characteristic | Multiple Myeloma (MM) Patients |
|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 11.2 |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants |
| Race/Ethnicity, Customized White | 7 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: Day 1, Day 2
Population: Each participant received both PET drugs by both diagnostic techniques (scans) and is therefore included in the analysis population for the four reporting groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multiple Myeloma (MM) Patients | Mean Multiple Myeloma Lesions Detected | C-11 acetate PET CT | 4.6 number of lesions | Standard Deviation 5.1 |
| Multiple Myeloma (MM) Patients | Mean Multiple Myeloma Lesions Detected | C-11 acetate PET MRI | 4.4 number of lesions | Standard Deviation 5.2 |
| Multiple Myeloma (MM) Patients | Mean Multiple Myeloma Lesions Detected | 18 FDG PET CT | 1.1 number of lesions | Standard Deviation 1.7 |
| Multiple Myeloma (MM) Patients | Mean Multiple Myeloma Lesions Detected | 18 FDG PET MRI | 1.0 number of lesions | Standard Deviation 1.8 |
Secondary
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).
Time frame: Approximately one month after Day 2
Population: Each participant received both PET drugs by both diagnostic techniques (scans) and is therefore included in the analysis population for the four reporting groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multiple Myeloma (MM) Patients | Visual Image Analysis of Detected Multiple Myeloma Lesions | C-11 acetate PET CT | 3.1 score on a scale | Standard Deviation 1.9 |
| Multiple Myeloma (MM) Patients | Visual Image Analysis of Detected Multiple Myeloma Lesions | C-11 acetate PET MRI | 3.3 score on a scale | Standard Deviation 1.8 |
| Multiple Myeloma (MM) Patients | Visual Image Analysis of Detected Multiple Myeloma Lesions | 18 FDG PET CT | 1.9 score on a scale | Standard Deviation 2 |
| Multiple Myeloma (MM) Patients | Visual Image Analysis of Detected Multiple Myeloma Lesions | 18 FDG PET MRI | 2.0 score on a scale | Standard Deviation 1.9 |