Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Arm 1 objective will be to determine whether the addition of supine MRI to conventional imaging with mammography and or sonography and prone MRI will result in a lower positive margin rate in patients undergoing breast conserving surgery.

Arm 2 of the study patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.

A limitation of MRI studies of the breast is that MRI exams are performed with the patient prone and the breasts in a pendant position, which is markedly different than the position of the breast when the patient is supine on the Operating Room table. The spatial information the surgeon receives from the prone MRI about the site of the tumor in the breast is hard to mentally translate into the actual site of the tumor in the breast of a supine patient prepared for surgery.

Supine MRI

This is a 2 Phase study. In the first phase of the study, patients with palpable invasive breast cancer underwent pre-operative supine MRI and optical scanning in the surgical position. In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.

We propose to use a novel technique (optical scanning) to correlate the supine MRI image to the surgical position in the OR and then to confirm and extend the Japanese study described above. In the first phase of the study, 5-25 patients with palpable invasive breast cancer will undergo pre-operative supine MRI and optical scanning in the surgical position. The purpose of this phase will be ensure that the images created from the optical scanner-adjusted supine MRI images closely correspond to the location of the palpable tumors in these breasts. All patients will then have their tumor resected using the standard method of either palpation or image guided wire localization. The first phase has been completed.

In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.

Our secondary objectives will be to determine:

1. whether there are differences between the two groups in the volume of breast tissue removed.
2. whether diagnostic information obtained from a supine MRI is equivalent to that obtained from the prone MRI.

A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery

Mean calculated from differences in precise distances from the nipple to the superior, inferior, medial and lateral edges of the tumor as determined from the adjusted MRI images and conventional MRI.

The primary analysis consists of computing the positive margin rate observed in the two groups and comparing them with a chi-squared test and finally comparing the proportion of patients with positive margins in the two groups based on study criteria.

The mean specimen volumes to be compared using t - statistics. The concordance between lesion volumes identified on the supine MRI images and the prone MRI images will be evaluated through correlation and regression analysis.

Dartmouth-Hitchcock Medical Center

Section Chief, General Surgery

Regular investigator assessment and regular laboratory testing

Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)

Phase 1: Addition of Supine MRI to Conventional Imaging

Phase 2: Addition of Supine MRI to Conventional Imaging

Wire localized (group WL) partial mastectomy

Phase 2: Conventional Imaging (SOC)

Total

>=18 years

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr Richard J. Barth Jr.

The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor.

To Determine Whether the Addition of Supine MRI to Conventional Imaging With Mammography and Prone MRI Results in a Lower Positive Margin Rate in Patients Undergoing Breast-conserving Surgery.

Differences Between the Two Groups in the Volume of Breast Tissue Removed

Overall Study

* Standard MRI will be performed
* Supine MRI will be performed
* Participant will receive mammography and ultrasound
* Breast Radiologist will take a brief survey.
* Patients will undergo upfront surgery or receive Neoadjuvant Therapy per standard of care
* Standard of care will be performed

Neoadjuvant Therapy (NAT)

Ultrasound

Mammography

Standard of Care

Standard MRI

Tari King, MD

This research study involves the use of a common breast imaging modality (magnetic resonance imaging, 'MRI') and is investigating its role in evaluating surgical decision making for breast cancer when it is performed with the patient in a new position (lying on one's back) as opposed to in the standard position (lying on one's stomach).

The procedure involved is called a supine breast magnetic resonance imaging (MRI).In this study, the investigators are evaluating the value of supine MRI in surgical decision making for women with breast cancer either undergoing upfront surgery or for those anticipating surgery after receiving neoadjuvant therapy.

The purpose of this study is to assess the value of supine breast MRI as a new imaging method to assist in surgical treatment planning. It is possible that the use of supine breast MRI will help your doctor see the size and location of tumors more accurately

Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy

Comparing tumor size as measured on prone MRI images with tumor size as measured on final pathology among pts undergoing upfront surgery and among pts undergoing neoadjuvant chemotherapy. In the neoadjuvant chemotherapy group the post-treatment MRI images were used.

Compared tumor size as reported by radiologist on the clinical report between Supine Breast MRI and The Pathologic Residual Tumor Size as reported by the pathologist on the final surgical pathology report..

Correlate maximal tumor Dimensions as measured by the radiologist between the Prone and Supine MRI Images

Reported as the proportion of surgeons answering yes. Surgeon reported answers to surveys asking if the supine MRI helped in the performance of the surgical procedure.

Dana-Farber Cancer Institute

Principal Investigator

The definition does not differ from the clinicaltirals.gov definitions.

* Standard MRI will be performed
* Supine MRI will be performed
* Participant will receive mammography and ultrasound
* Breast Radiologist will take a brief survey.
* Patients will undergo upfront surgery or receive Neoadjuvant Therapy per standard of care
* Standard of care will be performed

Supine MRI

Neoadjuvant Therapy (NAT)

Ultrasound

Mammography

Standard of Care

Standard MRI

Age, Categorical

Age, Continuous

Ethnicity (NIH/OMB)

Dr. Tari King

Comparison of tumor size between standard (prone) MRI imaging and surgical pathology

Standard (Prone) MRI Tumor Imaging

Analysis performed of 38 patients with Prone MRI imaging measurements and surgical pathology measurements

Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size

Patients with both supine MRI measurements and pathologic tumor size measurements

Supine MRI and Pathologic Tumor Size

We analyzed MRI tumor size and pathologic tumor size for 26 pts with both supine MRI measurements and final pathology measurements

Correlation Between Supine Breast MRI for Estimation Of Tumor Size and The Pathologic Tumor Size

comparison of maximum tumor dimension as measured on prone MRI imaging versus supine MRI imaging

Patients With Imaging in Both the Prone and Supine Positions

40 pts who had both a prone and a supine MRI measurement of tumor size

Correlation of Breast Tumor Dimensions Between Prone and Supine Imaging Positions.

Patients having supine MRI imaging and proceeding with breast conserving surgery

Breast Conserving Surgery Patients

among 30 pts analyzed, 13 surgeons reported the supine imaging was helpful whereas 17 surgeons reported the imaging was not helpful

The Perceived Benefit Of Supine MRI For Surgical Planning As Measured By The Collective Results Of A Survey Of Surgeons Performing Breast-conserving Therapy (BCT) In Our Study Patient Population

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Epinephrine

Racepinephrine

Epinephryl borate

After completion of the standard prone MRI sequences the patient will be positioned supine, coils will be placed and baseline images will be obtained. Then a second dose of contrast equal to the first dose will be given, and additional images will be obtained

Roberta diFlorio-Alexander, MD

The purpose of this study is to determine whether a supine breast MRI obtained with a second intravenous injection of gadolinium contrast immediately after a standard clinical prone breast MRI will provide sufficient tumor visualization to allow a Radiologist to define and outline the tumor edges ("segment" the tumor). Accurate segmentation will allow a 3-D image of the tumor to be generated to create a breast cancer locator (BCL) surgical device to in aid removal of breast cancers.

The clinical pre-operative breast MRI exam will be obtained in the prone position with intravenous (IV) Gadolinium (Gd) contrast injection per standard of care clinical protocol. After completion of the standard clinical prone breast MRI, the participant will be re-positioned and the investigative supine breast MRI protocol with a second dose of IV Gd will be obtained. A second dose of contrast equal to the first dose will be given, and additional images will be obtained in the supine position. Subtraction images will be generated for both the prone and the supine sequences. It is hypothesized that the second contrast injection will generate tumor-to-fibroglandular contrast differences such that supine subtraction images will allow visualization and segmentation of the tumor equal to prone segmentation images. It is expected that the addition of a second injection of contrast will improve the ability to visualize and accurately segment the supine post-Gd images. While the total dose of gadolinium delivered in two injections is twice the amount normally given during a clinical prone breast MRI, this total dose is equal to that administered for other clinical MRI studies such as cardiac MRI.

No additional imaging or testing will be required for this research study following the standard clinical MRI.

21DIF039: Prone to Supine Breast MRI II, P2S2 Breast MRI Trial

Prone to Supine Breast MRI Trial II, P2S2 MRI Trial

Determine the time required to obtain the double contrast prone to supine exam by recording start and stop times of both Supine and Prone MRI, using minutes and seconds. Compare exam time to single contrast prone to supine (prior study)

Determine the mean tumor-to-fibroglandular contrast in a two bolus intravenous contrast injection prone to supine breast MRI study and compare this to the mean tumor-to-fibroglandular contrast of a single-contrast injection prone to supine breast MRI study.

Compare the proportion of cases with successful agreement between radiologists' segmentation volumes in the double-contrast dose prone to supine MRI study to proportion of cases with successful agreement in the single-contrast dose prone to supine MRI using a Hausdorff Distance (HD) threshold \< 1 cm.

CairnSurgical, Inc.

Staff Physician, Radiology

The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure.

This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator, so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin.

Breast Cancer Locator (BCL)

Richard J Barth, Jr., MD

The project objective is to determine whether the Breast Cancer Locator (BCL) can safely and effectively localize breast cancers in patients treated at locations distant from the site of BCL manufacture. This information will be transmitted to CairnSurgical, Inc. where the BCL will be fabricated, tested for quality assurance, sterilized and shipped to the patient's surgeon. The surgeon will then utilize the BCL at the time of resection of the palpable breast cancer.

The primary purpose of the study is to determine whether a device called the Breast Cancer Locator (BCL) accurately identifies the location of cancer in the breast. The Breast Cancer Locator is a plastic bra-like form that gives the surgeon information about the location of the cancer in the breast. The location information is derived from an MRI which is obtained with the patient lying flat on their back (just as they are on an operating room table). The BCL is then custom-made for the patient using 3D printing technology.

The surgeon can feel the cancer, and the surgeon will remove the cancer by feeling the edges of it as the surgeon would normally. Since the cancer can be felt, the surgeon does not need an image guidance system such as the BCL to locate the cancer in the breast. Other women may have breast cancers that cannot be felt, but are only identified by mammography or MRI. If the BCL proves to accurately localize breast cancer, it may be a useful guide for the surgeon for these other women.

Additionally, the investigators want to determine whether this technology can be successfully employed at multiple sites and what, if any, complications occur during surgery as a result of using this device. The BCL has been used in 19 patients at Dartmouth with no complications.

A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers

Yes/No answer from Radiologist. Final measure will be % of cases rated Yes (wire deployed within the cancer on specimen mammogram).

Yes/No answer from Radiologist. Final measure will be % of cases rated Yes (tumor segregated accurately from supine MRI). The data is recorded by the radiologist on the CRF form.

Unit of measure is in days. Final measure will be average days to delivery among all patients. The data is recorded by the surgeon on the CRF form.

Yes/No answer from Surgeon. Final measure will be % of cases rated Yes (BCL enabled surgeon to successfully place all cues). The data is recorded by the surgeon on the CRF form.

Unit of measure is in mL, calculated by water displacement. Final measure will be average volume (mL) among all patients. The data is recorded by the study sponsor, Cairn Surgical, on the CRF form.

Unit of measure is in minutes. Final measure will be average operative time (min.) among all patients. Data is collected by the surgeon from operative notes and placed in the CRF form.

Unit of measure is in cm. Final measure will be average margin (in cm) among all patients. Data is collected by the surgeon from the pathology report and reported in the CRF form.

Surgeon to list any complications - which could include infections or bruising. Final measure will be % of patients with complications. Data is collected from the surgeon either post-operatively, if there were operative complications; or at the post-operative follow-up appointment with the patient, if she reports any complications then. It is also possible this data could be collected at any time between surgery and follow up appointment by the patient calling the surgeon's office to report it. The surgeon records this data in the CRF form.

Yes/No answer. Final measure will be % of surgeons who say Yes to satisfaction with the procedure. Data is collected from the surgeon and reported in the CRF form.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery	NCT01929395	Breast Cancer	Supine MRI	18 Years -	Dartmouth-Hitchcock Medical Center
Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy	NCT02956473	Breast Cancer	Supine MRI Neoadjuvant The... Ultrasound Mammography Standard of Car... Standard MRI	18 Years -	Dana-Farber Cancer Institute
A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery	NCT01929395	Breast Cancer	Supine MRI	18 Years -	Dartmouth-Hitchcock Medical Center
21DIF039: Prone to Supine Breast MRI II, P2S2 Breast MRI Trial	NCT05131607	Breast Cancer F...	Supine MRI	18 Years -	Dartmouth-Hitchcock Medical Center
Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy	NCT02956473	Breast Cancer	Supine MRI Neoadjuvant The... Ultrasound Mammography Standard of Car... Standard MRI	18 Years -	Dana-Farber Cancer Institute
A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers	NCT03573661	Palpable Breast...	Breast Cancer L...	18 Years -	Dartmouth-Hitchcock Medical Center
A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers	NCT03573661	Palpable Breast...	Breast Cancer L...	18 Years -	Dartmouth-Hitchcock Medical Center

Spots Global Cancer Trial Database for supine mri

Every month we try and update this database with for supine mri cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for supine mri

Every month we try and update this database with for supine mri cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for supine mri cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.