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.
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
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 group | Role | What they receive |
|---|---|---|
| Whole Body MRI | Not described Receives: Procedure: Whole Body MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted14 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Jingfei Ma, PhD, Principal investigator, M.D. Anderson Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body MRI for Detection of Cancer Metastases
- ClinicalTrials.gov ID
- NCT00592462
- Acronym / sponsor ID
- 2007-0539
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Whole Body MRI, Magnetic Resonance Imaging, Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Study start
- Dec 2007
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole Body MRI | – | Procedure: Whole Body MRI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Breast cancer patients with a high suspicion or confirmed bone metastases.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) Contraindication to conventional MR imaging (e.g. metal implants, pace maker, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body MRIThe 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. | Procedure or surgery | Whole Body MRI |
Primary outcome
Develop and evaluate a whole body MRI technique for detecting cancer metastases.
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingfei Ma, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
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.