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NCT Number: NCT03573804

The Prone to Supine Breast MRI Trial

The purpose of this study is to determine whether a supine MRI obtained immediately after a standard diagnostic prone MRI exam, without a second injection of gadolinium (Gd) contrast material, would be of sufficient quality to allow the Radiologist to define the tumor edges ("segment" the tumor) so that a 3-D image of the tumor can be generated to form a BCL.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

The purpose of this study is to find out whether additional MRI images taken with patients in a different position after completing a standard MRI are of sufficient quality to allow a radiologist to identify the edges of the tumor.

These additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.The information gathered in this study will make it more feasible to use a new device called the "breast cancer locator" to help surgeons more accurately remove breast cancers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years.
  • Female gender.
  • Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
  • Tumor size at least 1 cm in diameter as visualized on mammogram or US.
  • A diagnostic breast MRI is considered to be clinically indicated.
  • Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.

Exclusion criteria

  • Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.
  • Severe claustrophobia.
  • Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (eGFR < 30 ml/min/1.73m2).
  • History of median sternotomy.
  • Pregnancy. Patient attestation that they are not pregnant will be acceptable.
  • Patients who have received neoadjuvant chemotherapy.

Treatment and study plan

Prone to Supine MRI

Other

The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.

Primary outcomes

  1. Number of Successful Segmentation of Supine MRI Images

    Time frame: 30 minutes

    Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.

Secondary outcomes

  1. Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor

    Time frame: 30 minutes

    Compare the signal intensity with that obtained at tumor location on the prone and supine imaging. The amount of enhancement at the tumor site = segmented tumor.

  2. Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary

    Time frame: 30 minutes

    Compare the signal intensity with that obtained in benign tissue surrounding the tumor on the prone and supine imaging.

  3. Enhancement Quantification- Tumor-to-Background Ratio

    Time frame: 30 minutes

    Mean MRI signal of the segmented tumor divided by the mean MRI signal of the surrounding tissue which has an equal volume to the tumor. The difference between tumor and benign breast tissue is the tumor-to-background ratio

  4. Time to Position and Obtain Supine Images

    Time frame: 30 Minutes

    Calculate the additional time needed to obtain supine MRI images. After the completion of Prone imaging, the patient was removed from the MRI, turned over to the supine position, new coils placed, and returned to the MRI for additional imaging. The aggregate time to accomplish these tasks are noted in minutes.

  5. Overall Comfort for Prone and Supine Positions

    Time frame: Within 15 minutes of the scan

    Quantify the perceived comfort level of the prone and supine MRI as reported by participants. A single question using a Likert scale was was used. The scale range was 0 to 5, where 0 = no pain, completely comfortable and 5 = considerable discomfort.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 29, 2018
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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