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NCT03262389 Clinical Trial

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

Multiple Myeloma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03262389
Other study ID # 16-007867
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 19, 2017
Est. completion date November 23, 2019

Study information
Verified date February 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date November 23, 2019
Est. primary completion date November 23, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fludeoxyglucose PET CT
Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
• Sodium Acetate C11 PET CT
Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
• Fludeoxyglucose PET MRI
Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
• Sodium Acetate C11 PET MRI
Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).

Locations
Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Michael C Roarke, MD

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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. Day 1, Day 2
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). Approximately one month after Day 2
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