Intra-operative Digital vs. Standard Mammography
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2013 |
| Contact: | MIchelle Specht, MD |
| Email: | mspecht@partners.org |
| Phone: | 617-726-0340 |
A Comparison of Intra-Operative Digital Specimen Mammography to Standard Specimen Mammography
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.
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.
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.
Inclusion Criteria:
- Newly diagnosed with a breast abnormality undergoing an excisional biopsy with wire
localization or newly diagnosed with invasive breast cancer or ductal carcinoma
undergoing a lumpectomy with wire localization
- Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
- Recurrent breast cancer
- Palpable masses not requiring wire localization
We found this trial at
1
site
Click here to add this to my saved trials
