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Completed

NCT Number: NCT03262389

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludeoxyglucose PET CT

Drug

Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).

Other names: F-18 FDG PET CT

Sodium Acetate C11 PET CT

Drug

Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).

Other names: C-11 acetate PET CT

Fludeoxyglucose PET MRI

Drug

Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).

Other names: F-18 FDG PET MRI

Sodium Acetate C11 PET MRI

Drug

Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).

Other names: C11 PET MRI

Primary outcomes

  1. Mean Multiple Myeloma Lesions Detected

    Time frame: Day 1, Day 2

    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 outcomes

  1. Visual Image Analysis of Detected Multiple Myeloma Lesions

    Time frame: Approximately one month after Day 2

    The visual image analysis scale has a range of 0-4: (0 no uptake; 1 benign, 2 probably benign, 3 probably malignant, 4 malignant).

Sponsors and collaborators

Lead sponsor

Michael C Roarke, MD

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 25, 2017
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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