Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

The patient's breast specimen will be imaged in the operating room in an intra-operative imaging device - Biovision SN #30042

Intra-operative Mammography

There is not an added device associated with this arm.

Standard Mammography

Michelle Specht, MD

A breast biopsy in the operating room may be needed in up to 15% of patients with an abnormality on mammogram. When an abnormality is present but there is no palpable mass, the abnormality must be localized with a wire before going to the operating room. This technique is also used when a breast cancer is present but there is no mass, in order to perform a targeted lumpectomy. Once the abnormality is surgically removed, the specimen with the wire is taken to the breast imaging department for a specimen x-ray to ensure that the targeted abnormality is present within the specimen. If the abnormality is close to the edge of the specimen, additional tissue is often removed.

A newer method for evaluating the specimen is to perform imaging in the operating room. Portable digital mammography units are available for this purpose. The Biovision digital specimen mammography system is FDA-approved and currently in use in over 200 centers in the United States. Several studies have shown that intra-operative digital mammography is as accurate as standard specimen mammography and takes less time to perform. It may also decrease the chance of having to go back to the operating room to take more breast tissue after lumpectomy because of cancer cells near teh margin(s) of the specimen on final pathology. Having to go back to the operating room to take more tissue is called a re-excision.

The purpose of this study is to compare standard specimen mammography to intra-operative specimen mammography to quantify potential operating room time savings and to determine if the use of intra-operative specimen mammography decreases re-excision rates. We aim to see if intra-operative specimen mammography is more efficient and if it decreases re-excision rates.

Before the research starts patients will undergo some screening procedures to determine if patients are eligible to participate. This includes a medical history and an assessment of the patient's breast abnormality by mammogram and/or ultrasound and/or breast MRI. Patients will not need to undergo any extra procedures apart from those needed by the patient's surgeon to plan the patient's breast surgery. If the screening process shows that a patient is eligible to participate in this research study, the patient will be enrolled and the study will proceed on the day of surgery. If a patient does not meet the eligibility criteria the patient will not be able to participate in this research study.

Patients will be assigned to one of two arms of this study on the day of your surgery. Because no one knows which of the breast specimen imaging options is best, patients will be "randomized" into one of the study groups: the Standard Specimen Mammography arm or, the Intra-operative Specimen Mammography arm. Randomization means that the patient is put into a group by chance. It is like flipping a coin. Neither the patient nor the surgeon will choose what group the patient will be in.

If the patient is in the Standard Specimen Mammography arm, the patient's breast specimen (biopsy or lumpectomy) will be taken to the Breast Imaging department for a mammogram, which is the way breast specimens are typically imaged. If the patient is in the Intra-Operative Specimen Mammography arm, the patient's breast specimen will be imaged right in the operating room at the time of the surgery. The patient's images will also be linked to the Breast Imaging department, so the radiologist can confirm the surgeon's findings.

Intra-operative Digital vs. Standard Mammography

A Comparison of Intra-Operative Digital Specimen Mammography to Standard Specimen Mammography

To compare the overall operative time savings using intra-operative digital mammography compared with standard specimen mammography.

Assessment of radiographic findings and pathologic findings to determine sensitivity, specificity, positive predictive value, and negative predictive values of intra-operative digital specimen mammography (ISM) and standard specimen mammography for determining margin status.

* A true positive (TP) was defined as a positive margin by imaging (ISM or SSM) and pathology
* A false positive (FP) was defined as a positive margin by imaging but negative by pathology
* A true negative (TN) was defined as a negative margin by both imaging and pathology.
* A false negative (FN) was defined as a negative margin by imaging but positive by pathology
* The sensitivity \[TP/(TP + FN)\], specificity \[TN/(TN + FP)\], positive predictive value \[TP/ (TP + FP)\], and negative predictive value \[TN/(TN + FN)\] for identification of positive margins were calculated for ISM and SSM.

Massachusetts General Hospital

Principal Investigator

Adverse Event information was not collected as a part of this trial

Intra-operative Specimen Mammography

Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042

Standard Specimen Mammography

Standard Mammography: There is not an added device associated with this arm.

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Body Mass Index is a weight to height ratio calculated by dividing someone's weight in Kg by the square of someone's height in meters.

Excisional Biopsy

Atypia

Invasive Carcinoma/DCIS

The indication for the excision:

* An Excisional biopsy is a procedure where the entire abnormality or area of interest is removed.
* Atypical Hyperplasia is a precancerous condition that is defined by an atypical accumulation of abnormal cells in the breast.
* Ductal carcinoma in situ (DCIS) is the presence of abnormal cells inside a milk duct in the breast. DCIS is considered the earliest form of breast cancer.
* Invasive Carcinoma is a cancer that began growing in a duct in the breast and has since invaded the fatty tissue of the breast outside of the duct.

Reason for excision

Clip

Mass/ Calcs/ Arch distort

A thin wire is inserted down to the target area of breast so that during surgery the surgeon can follow the guide wire down to the target area and remove the wire and the tissue around it. A clip is a marker that is placed in the breast during a biopsy that can be used a target for wire insertion. Mass means a solid mass in the breast. Calculated means that the target location was either manually or computer calculated. Architectural distortion (arch distort) is when a mammogram shows tethering or indentation of breast tissue but without an apparent associated mass.

Wire-localization Target

General

The type of anesthesia used during the procedure. Monitored anesthesia care (MAC) is when a patient undergoes local anesthesia together with sedation and analgesia. General anesthesia is anesthesia that affects the whole body and usually induces a loss of consciousness.

Anesthesia Type

None

SLNB

ALND

Type of axillary lymph node surgery

* SLNB= Sentinel Lymph Node Biopsy
* ALND= Axillary Lymph Node Dissection

Axillary Surgery

H0: Procedure time is not significantly different based on mammography type used

H0: Operating room time is not significantly different based on mammography type used

Procedure Time

OR Time

Comparison of Operative Time Savings

Sensitivity

Specificity

Positive Predicitve Value

Negative Predictive Value

Interpretation of margin status by the surgeon was available for 22 of 36 ISM patients. Interpretation of margin status was also available for 22 of 36 SSM patients.

Assessment of Radiographic and Pathologic Findings

Overall Study

Breast Diseases

Skin Diseases

Standard mammography

Standard mammography and tomosynthesis

cedric De Bazelaire, MD PHD

Matthieu Resche-Rigon, MD PHD

matthieu resche-rigon

Isabelle THOMASSIN- NAGGARA, Pr

Tomosynthesis is an innovative technique developed in digital mammography for obtaining a sectional image of the breast. Mammography has the main disadvantage of being an imaging projection that creates overlays, which eliminates tomosynthesis.

The objective of this study is to evaluate if the BI-RADS classification obtained by tomosynthesis with synthetic mammography is superior to that obtained by conventional mammography in terms of specificity while not inferior in terms of sensitivity.

Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions

EVALUATION DE LA TOMOSYNTHESE DANS LA CARACTERISATION ET LA PRISE EN CHARGE DES LESIONS MAMMAIRES : "ETOLE"

The primary evaluation parameter will be the classification error of tumors according to the BiRads scale obtained by mammography (BiRadsM) and by tomosynthesis (BiRadsT) according to the gold standard.

The visibility (presence or absence) of signs of poor prognosis criteria. We will compare the visibility of poor prognosis criteria seen on mammography + ultrasound and seen on tomosynthesis with synthetic mammography + ultrasound.

Needs for supplementary breast imaging exams and biopsies

The reproducibility of the interpretation of tomosynthesis will be assessed with differences of classifications BiRadsT observed between the two radiologists

Cumulative incidence of Breast cancer diagnosis among women with benign at after primary evaluation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intra-operative Digital vs. Standard Mammography	NCT01766102	Breast Cancer	Intra-operative... Standard Mammog...	18 Years -	Massachusetts General Hospital
Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions	NCT02959398	Breast Neoplasm... Tomosynthesis BRCA1 Protein BRCA2 Protein	Standard mammog... Standard mammog...	18 Years -	Assistance Publique - Hôpitaux de Paris

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