search
Back to results

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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fludeoxyglucose PET CT
Sodium Acetate C11 PET CT
Fludeoxyglucose PET MRI
Sodium Acetate C11 PET MRI
Sponsored by
Michael C Roarke, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma focused on measuring positron emission tomography (PET), computerized tomography (CT), Magnetic resonance imaging (MRI), Fludeoxyglucose (F-18 FDG), C-11 acetate

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multiple Myeloma Patients

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
August 22, 2017
Last Updated
February 22, 2021
Sponsor
Michael C Roarke, MD
search

1. Study Identification

Unique Protocol Identification Number
NCT03262389
Brief Title
Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
November 23, 2019 (Actual)
Study Completion Date
November 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael C Roarke, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
positron emission tomography (PET), computerized tomography (CT), Magnetic resonance imaging (MRI), Fludeoxyglucose (F-18 FDG), C-11 acetate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiple Myeloma Patients
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Fludeoxyglucose PET CT
Other Intervention Name(s)
F-18 FDG PET CT
Intervention Description
Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
Intervention Type
Drug
Intervention Name(s)
Sodium Acetate C11 PET CT
Other Intervention Name(s)
C-11 acetate PET CT
Intervention Description
Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
Intervention Type
Drug
Intervention Name(s)
Fludeoxyglucose PET MRI
Other Intervention Name(s)
F-18 FDG PET MRI
Intervention Description
Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
Intervention Type
Drug
Intervention Name(s)
Sodium Acetate C11 PET MRI
Other Intervention Name(s)
C11 PET MRI
Intervention Description
Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
Primary Outcome Measure Information:
Title
Mean Multiple Myeloma Lesions Detected
Description
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
Secondary Outcome Measure Information:
Title
Visual Image Analysis of Detected Multiple Myeloma Lesions
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael C Roarke
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs