Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Fludeoxyglucose PET CT
* Drug: Sodium Acetate C11 PET CT
* Drug: Fludeoxyglucose PET MRI
* Drug: Sodium Acetate C11 PET MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple Myeloma Patients<br>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<br>* Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).<br>* Other names: F-18 FDG PET CT;Drug: Sodium Acetate C11 PET CT<br>* Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).<br>* Other names: C-11 acetate PET CT;Drug: Fludeoxyglucose PET MRI<br>* Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).<br>* Other names: F-18 FDG PET MRI;Drug: Sodium Acetate C11 PET MRI<br>* Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).<br>* Other names: C11 PET MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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positron emission tomography (PET), computerized tomography (CT), Magnetic resonance imaging (MRI), Fludeoxyglucose (F-18 FDG), C-11 acetate