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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-19

Study Completion Date

2019-11-23

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.

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Multiple Myeloma Patients

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.

Group Type EXPERIMENTAL

Fludeoxyglucose PET CT

Intervention Type DRUG

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

Sodium Acetate C11 PET CT

Intervention Type DRUG

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

Fludeoxyglucose PET MRI

Intervention Type DRUG

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

Sodium Acetate C11 PET MRI

Intervention Type DRUG

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

Interventions

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Fludeoxyglucose PET CT

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

Intervention Type DRUG

Sodium Acetate C11 PET CT

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

Intervention Type DRUG

Fludeoxyglucose PET MRI

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

Intervention Type DRUG

Sodium Acetate C11 PET MRI

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

Intervention Type DRUG

Other Intervention Names

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F-18 FDG PET CT C-11 acetate PET CT F-18 FDG PET MRI C11 PET MRI

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No