A Phase 2 interventional study of Fludeoxyglucose PET CT and Sodium Acetate C11 PET CT in Multiple Myeloma, sponsored by Michael C Roarke, MD. Completed at 1 site in United States. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-03-16.
Sponsored by Michael C Roarke, MD · Phase 2, Interventional, and Diagnostic
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.
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.
Exclusion Criteria:
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.
Drug: Fludeoxyglucose PET CT · Drug: Sodium Acetate C11 PET CT · Drug: Fludeoxyglucose PET MRI · Drug: Sodium Acetate C11 PET MRI
Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
Also known as: F-18 FDG PET CT
Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
Also known as: C-11 acetate PET CT
Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
Also known as: F-18 FDG PET MRI
Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
Also known as: C11 PET MRI
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
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
| Milestone | Multiple Myeloma (MM) Patients |
|---|---|
| Started | 10 |
| Completed | 7 |
| Not completed | 3 |
| Withdrew: Machine malfunction day 1, no return day 2 | 1 |
| Withdrew: Opted out of the study once his clinical fdg pet ct was done. | 1 |
| Withdrew: Opted out of pet/mr | 1 |
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.
| number of lesions | Multiple Myeloma (MM) Patients |
|---|---|
| C-11 acetate PET CT | 4.6 ± 5.1 |
| C-11 acetate PET MRI | 4.4 ± 5.2 |
| 18 FDG PET CT | 1.1 ± 1.7 |
| 18 FDG PET MRI | 1.0 ± 1.8 |
The visual image analysis scale has a range of 0-4: (0 no uptake; 1 benign, 2 probably benign, 3 probably malignant, 4 malignant).
| score on a scale | Multiple Myeloma (MM) Patients |
|---|---|
| C-11 acetate PET CT | 3.1 ± 1.9 |
| C-11 acetate PET MRI | 3.3 ± 1.8 |
| 18 FDG PET CT | 1.9 ± 2.0 |
| 18 FDG PET MRI | 2.0 ± 1.9 |
Collected over Adverse Events were collected from baseline to one day following the last administration of study treatment, for at total of approximately 3 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multiple Myeloma (MM) Patients | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Multiple Myeloma (MM) Patients |
|---|---|
| Mean | 64.4 ± 11.2 |
| Sex: Female, Male(Participants) | Multiple Myeloma (MM) Patients |
|---|---|
| Female | 3 |
| Male | 7 |
| Race/Ethnicity, Customized(Participants) | Multiple Myeloma (MM) Patients |
|---|---|
| White | 7 |
| Black or African American | 1 |
| Hispanic or Latino | 2 |
| Region of Enrollment(participants) | Multiple Myeloma (MM) Patients |
|---|---|
| United States | 10 |
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