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

Michael C Roarke, MD

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Sodium Acetate C11 PET CT; Drug: Sodium Acetate C11 PET MRI; Drug: Fludeoxyglucose PET MRI; Drug: Fludeoxyglucose PET CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03262389

16-007867

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Multiple Myeloma Patients

Experimental group

Description:

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.

Treatment:

Drug: Fludeoxyglucose PET CT

Drug: Fludeoxyglucose PET MRI

Drug: Sodium Acetate C11 PET MRI

Drug: Sodium Acetate C11 PET CT