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Breast CancerNCT00592462

Whole Body Magnetic Resonance Imaging (MRI) for Detection of Cancer Metastases

An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this pilot study is to develop and evaluate a whole body MRI technique for detecting cancer metastases. The whole body MRI will include T1-weighted and T2-weighted phase-sensitive MR imaging as well as diffusion weighted imaging of the whole body in multiple patient table stations. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Whole Body MRI
Type of treatment
Surgery or procedure
How many people
32 participants
Where
1 siteUnited States
Study dates
Dec 2007to Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Breast cancer patients with a high suspicion or confirmed bone metastases.

Who may be able to join

  • Breast cancer patients with high suspicion or confirmed bone metastases.
  • Patient who have undergone a clinically indicated skeletal scintigraphy within two weeks of the MRI exam.
  • Patients who have signed their informed consent form to undergo the study.

Who cannot join

  • 1) Contraindication to conventional MR imaging (e.g. metal implants, pace maker, etc.).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Whole Body MRI for Detection of Cancer Metastases

The objective of this pilot study is to develop and evaluate a whole body MRI technique for detecting cancer metastases. The whole body MRI will include T1-weighted and T2-weighted phase-sensitive MR imaging as well as diffusion weighted imaging of the whole body in multiple patient table stations.

Read the detailed description

Researchers would like to find out if a new whole-body MRI technique is able to find cancer metastases better than a whole-body bone scan, which is the current standard of care.

Screening Tests:

Before you can start treatment on this study, you will have "screening questions" to help the doctor decide if you are eligible to take part in this study. You will be asked to complete some questionnaires to find out if there is any reason why you would not be able to receive an MRI scan. The questionnaires will cover topics such as whether you have a pacemaker and what medications you may be taking. It should take about 10-15 minutes to complete the questionnaires.

You will also have either a bone scan or positron emission tomography / computed tomography (PET/CT) during the screening period to check if the disease has spread to your bones. A bone scan is a picture that is taken, after a radioactive substance is injected into your bloodstream, allowing your doctor to see any abnormal areas of the bone. A PET/CT scan is a type of x-ray scan that uses an injected chemical to help the doctor "see" the image more clearly. For up to 6 hours before the PET/CT scan, you must not eat or drink anything except water. A small tube will be placed in your arm, and you will receive an injection of a very small amount of a mildly radioactive sugar material into your bloodstream. The radioactive nature of this injected material allows the scanner to "see" it in certain places in your body. After the injection, you will need to rest quietly until it is time for the scan. The amount of rest time may vary, but be prepared to wait for between 45 and 90 minutes. During the scan, you will lie flat on your back on a table. The scan itself may last up to 1 hour.

Study Procedures:

If you are found to be eligible and you agree to take part in this study, you will be scanned using a whole-body MRI, with and without a "contrast agent" (a chemical substance injected in your blood stream to help the scanner "see" your blood vessels better). This will be performed after you receive the bone scan as the standard of care scan.

MRI uses a large magnet instead of x-rays to take pictures of the inside of your body. People who have metal in their bodies (pacemakers, neurostimulators, certain clips, or staples from earlier surgery) may not receive an MRI. The magnetic field used in MRI scanning may harm such people or cause problems with devices such as pacemakers.

During the MRI procedure, part or all of the body will be passed into a long, narrow tube scanner, which is open at both ends. The scanner has an intercom, which will allow you to speak to the doctors and staff during the procedure. The machine will produce a loud knocking noise. This is normal. You will be given earplugs to protect your ears. The MRI will also require a line to be inserted into one of your veins to inject the contrast agent. Healthy volunteers participating in this study will not have the contrast agent injected during the scan.

Depending on how tall you are, imaging of your entire body will be achieved by the time you have been scanned at 5 or 6 different table positions. The table you are on for the scanning will be moved without having to reposition you. All images will be taken within a total scan time of about 1 hour.

The MRI findings will be compared with the bone scan that you received before the MRI. This comparison will help researchers to find out how well the MRI was able to "see" cancer metastases.

Study Length:

After the whole-body MRI, your participation in this study will be over.

This is an investigational study. All MRI scans will be performed on a commercially available GE Signa scanner (GE Healthcare, Milwaukee, WI). All the imaging techniques used will be done according to FDA MRI safety guidelines. Up to 35 patients and 5 healthy volunteers will take part in the study. All will be enrolled at M. D. Anderson.

Conditions
Breast Cancer
Being tested
Whole Body MRI
Keywords
Breast Cancer, Whole Body MRI, Magnetic Resonance Imaging, Metastases
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole Body MRIProcedure or surgery

    The whole body MRI will include T1-weighted and T2-weighted phase-sensitive MR imaging as well as diffusion weighted imaging of the whole body in multiple patient table stations.

Study groups in NCT00592462
Study groupRoleWhat they receive
Whole Body MRINot described
Receives: Procedure: Whole Body MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Develop and evaluate a whole body MRI technique for detecting cancer metastases.

    Measured: 3 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00592462
Sponsor's protocol ID
2007-0539
Other IDs
BCTR74106
Status last verified
Oct 2016
First submitted
2 Jan 2008
Last updated
27 Oct 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Develop and evaluate a whole body MRI technique for detecting cancer metastases. (time frame: 3 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.

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