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Breast CancerNCT01938651

Ultra High Field MRI and MRS Techniques in Diagnosing Breast Cancer

A study testing high field strength magnetic resonance imaging, magnetic resonance spectroscopic imaging and chemical exchange saturation transfer magnetic resonance imaging in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This pilot clinical trial studies ultra-high field magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) techniques in diagnosing breast cancer. New diagnostic procedures may be a more sensitive way to detect breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
high field strength magnetic resonance imaging, magnetic resonance spectroscopic imaging and chemical exchange saturation transfer magnetic resonance imaging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Jan 2013to Jun 2015
Phase
Interventional
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have signed an approved consent form
  • Must be at least 18 years old
  • Subjects must have undergone x-ray mammography and/or ultrasonography
  • Subjects must have undergone standard clinical (1.5 Tesla) MRI as part of their standard-of-care diagnostic workup:
  • To evaluate the extent of disease for a previously diagnosed cancer, or
  • To evaluate a clinically suspected lesion that was occult on mammography and/or ultrasonography, or
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  • Because the patient is considered high-risk (according to National Comprehensive Cancer Network [NCCN] criteria)
  • Subjects must be classified Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5
  • Subjects must be scheduled for diagnostic biopsy to evaluate a lesion that measures >10 mm in the greatest dimension.

Who cannot join

  • Subjects who have distant metastases
  • Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, aneurysm clip, etc), because such devices may be displaced or malfunction
  • Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced by the magnetic field of the MRI scanner
  • Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers, and machinists (potential for metallic fragments in or near the eyes)
  • Subjects with a history of renal disease (including renal cancer), diabetes, or human immunodeficiency virus (HIV)
  • Creatinine >= 1.5 times upper limit of normal
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  • Estimated glomerular filtration rate < 30 mL/min
  • Subjects who are pregnant or breast-feeding; the MRI Procedure Screening Form will be used to identify and exclude subjects who are pregnant or breastfeeding; a urine pregnancy test/or serum human chorionic gonadotropin (HCG) will also be performed for pre-menopausal women who are not using contraceptives
  • Subjects who have exhibited past allergic or other adverse reactions in response to intravenous injection of Magnevist (gadopentetate dimeglumine) or other gadolinium-containing contrast agents
  • Subjects who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet bore
  • Subjects incapable of giving informed written consent, for the following reasons:
  • Inability to adhere to the experimental protocols for any reason
  • Inability to communicate with the research team
  • Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders
  • Prisoners or other individuals deemed to be susceptible to coercion

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Ultra-High Field (7 Tesla) MRI/MRS Evaluation of Breast Cancer

This pilot clinical trial studies ultra-high field magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) techniques in diagnosing breast cancer. New diagnostic procedures may be a more sensitive way to detect breast cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To implement quantitative dynamic contrast-enhanced (DCE)-MRI, diffusion-weighted (DW)-MRI, 31 phosphorus (31P) MRS, magnetization transfer (MT)-MRI, chemical exchange saturation transfer (CEST)-MRI, and high-resolution structural imaging at 7 Tesla in patients for diagnosing breast tumors.

OUTLINE:

Patients undergo measurement of tumor perfusion and permeability using DCE-MRI, tumor cellularity using DW-MRI, phospholipid metabolism using 31P MRS, macromolecular content using MT-MRI, and cellular protein content using CEST-MRI. Diagnostic performance of one, or a combination, of these metrics will be investigated in the context of breast cancer.

Conditions
Breast Cancer
Being tested
high field strength magnetic resonance imaging, magnetic resonance spectroscopic imaging, chemical exchange saturation transfer magnetic resonance imaging, diffusion-weighted magnetic resonance imaging, dynamic contrast-enhanced magnetic resonance imaging
Medical subject headings
Breast Neoplasms

What participants receive

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

  • high field strength magnetic resonance imagingProcedure or surgery

    Also called high field strength MRI

    Undergo 7T MRI

  • magnetic resonance spectroscopic imagingProcedure or surgery

    Also called 1H-nuclear magnetic resonance spectroscopic imaging, Proton Magnetic Resonance Spectroscopic Imaging

    Undergo 31P MRS

  • chemical exchange saturation transfer magnetic resonance imagingProcedure or surgery

    Also called CEST MRI

    Undergo CEST-MRI

  • diffusion-weighted magnetic resonance imagingProcedure or surgery

    Also called diffusion-weighted MRI

    Undergo DW-MRI

  • dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery

    Also called DCE-MRI

    Undergo DCE-MRI

Study groups in NCT01938651
Study groupRoleWhat they receive
Diagnostic (7T ultra high-field MRI/MRS)ExperimentalPatients undergo measurement of tumor perfusion and permeability using DCE-MRI, tumor cellularity using DW-MRI, phospholipid metabolism using 31P MRS, macromolecular content using MT-MRI, and cellular protein content using CEST-MRI. All of these procedures are integrated into a single MRI exam lasting under 60 min.
Receives: Procedure: high field strength magnetic resonance imaging; Procedure: magnetic resonance spectroscopic imaging; Procedure: chemical exchange saturation transfer magnetic resonance imaging; Procedure: diffusion-weighted magnetic resonance imaging; Procedure: dynamic contrast-enhanced magnetic resonance imaging

What is being measured

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

  1. Sensitivity and specificity

    Ninety-percent simultaneous confidence rectangles for sensitivity and specificity will be constructed at the 25th, 50th (median), and 75th percentiles of the model predicted probability of disease.

    Measured: At time of imaging procedure

Secondary outcomes (1)

  1. Pathological disease status

    A generalized linear mixed models analysis of variance with a logit link will be used to predict pathological disease status from MRI and MRS parameters.

    Measured: At time of imaging procedure

Timeline

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

  1. First posted10 Sep 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionJun 2015
  4. Study completionJun 2015

Why it stopped: funding ceased

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01938651
Sponsor's protocol ID
VICC BRE 1277
Other IDs
NCI-2013-00435
Status last verified
Aug 2016
First submitted
4 Sep 2013
Last updated
3 Aug 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing high field strength magnetic resonance imaging, magnetic resonance spectroscopic imaging and chemical exchange saturation transfer magnetic resonance imaging in people with Breast Cancer, run by Vanderbilt-Ingram 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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 3 Aug 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 was stopped early (reason given: funding ceased). Results are not available in the source record.

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?

Sensitivity and specificity (time frame: At time of imaging procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01938651.

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 3 Aug 2016.

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