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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludeoxyglucose PET CT | Drug | Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1, Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Approximately one month after Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael C Roarke | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Each participant received both PET drugs by both diagnostic techniques (scans) and is therefore included in the analysis population for the four reporting groups. | Posted | Mean | Standard Deviation | number of lesions | Day 1, Day 2 |
|
Adverse Events were collected from baseline to one day following the last administration of study treatment, for at total of approximately 3 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael C. Roarke, M.D. | Mayo Clinic | 480-342-0988 | Roarke.Michael@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2017 | Feb 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Sodium Acetate C11 PET CT | Drug | Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq). |
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| Fludeoxyglucose PET MRI | Drug | Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi). |
|
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| Sodium Acetate C11 PET MRI | Drug | Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq). |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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). | Each participant received both PET drugs by both diagnostic techniques (scans) and is therefore included in the analysis population for the four reporting groups. | Posted | Mean | Standard Deviation | score on a scale | Approximately one month after Day 2 |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| 18 FDG PET MRI |
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