NCT03262389 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2021-03-16

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Mean Multiple Myeloma Lesions Detected

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outcome · POSTED

Visual Image Analysis of Detected Multiple Myeloma Lesions

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 20 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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 Names
Drug: Fludeoxyglucose PET CT
Drug: Sodium Acetate C11 PET CT
Drug: Fludeoxyglucose PET MRI
Drug: Sodium Acetate C11 PET MRI
label
Multiple Myeloma Patients
type
EXPERIMENTAL

interventions

arm Group Labels
Multiple Myeloma Patients
description
Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
name
Fludeoxyglucose PET CT
other Names
F-18 FDG PET CT
type
DRUG
arm Group Labels
Multiple Myeloma Patients
description
Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
name
Sodium Acetate C11 PET CT
other Names
C-11 acetate PET CT
type
DRUG
arm Group Labels
Multiple Myeloma Patients
description
Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
name
Fludeoxyglucose PET MRI
other Names
F-18 FDG PET MRI
type
DRUG
arm Group Labels
Multiple Myeloma Patients
description
Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
name
Sodium Acetate C11 PET MRI
other Names
C11 PET MRI
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

DIAGNOSTIC

Enrollment

count: 10
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Mean Multiple Myeloma Lesions Detected
time Frame
Day 1, Day 2

secondary Outcomes

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).
measure
Visual Image Analysis of Detected Multiple Myeloma Lesions
time Frame
Approximately one month after Day 2

Full 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.

Source references