Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases

NCT00375830 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2023-12-12

Study results available
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Summary

This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer.

Conditions

Interventions

PROCEDURE

Bone scan

Scan to diagnose a number of bone conditions including cancer or metastasis

DRUG

99mTc-methyl diphosphonate

Radiolabel for bone scan procedures

PROCEDURE

Positron Emission Tomography (PET) scan

Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F

DRUG

18F-Fludeoxyglucose (18F-FDG)

Radiolabel for positron emission tomography scan procedures

PROCEDURE

Computed Tomography (CT) scan

Scan to detect \& analyze X-rays

DRUG

18F-Sodium Fluoride (18F-NaF)

Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.

PROCEDURE

Whole Body Magnetic Resonance Imaging (WB-MRI) scan

Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields \& radio waves to generate images of the organs in the body.

DRUG

Gadopentetate dimeglumine

A gadolinium-based contrast agent for MRI

DRUG

Gadofosveset

A gadolinium-based contrast agent for MRI

DRUG

Gadobutrol

A gadolinium-based contrast agent for MRI

Sponsors & Collaborators

Principal Investigators

  • Andrei Iagaru, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2017-04-17
Completion
2019-03-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00375830 on ClinicalTrials.gov