Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Women with equivocal findings on Mammography, US and/or MRI

Women with discrepancy between clinical examination and breast imaging

Women in high risk for Breast Cancer. Including patients with genetic high risk and/or strong family history.

Einat Even-sapir, PhD, MD

Ayelet Kurzband, BA

Einat Even-Sapir, MD, PhD

Hedva Lerman, MD

Detection of breast cancer as early as possible is an ongoing imaging challenge.The purpose of the current study is to assess the clinical performance of the new scintigraphic technology, a dedicated breast gamma camera composed by the new generation of CZT detectors,for assessment of breast pathology specifically in women where current imaging techniques, mainly mammography are suboptimal. These cohort are patients with dense breast tissue and patients who are at high risk for breast cancer by a combination of other metrics, including family history and genetic testing. BRCA (breast cancer susceptibility gene), is particularly a relevant health problem among Ashkenazi Jews in Israel.

Recently, a breast-dedicated gamma camera has been used for assessment of breast malignancy in over 1000 women in Mayo Clinic, Rochester, USA. Molecular Breast Imaging (MBI), which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography, has been shown to have a high sensitivity (91%) for the detection of breast lesions \> 5 mm in diameter and 69% for tumors smaller than 5mm.

In Israel , genetic high- risk for breast cancer is highly relevant. We will offer the new imaging technology, to a wide patients population/group from all over Israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. Therefore this stage will include:

* Women with equivocal findings on Mammography, US and/or MRI
* Women with discrepancy between CBE(clinical breast examination)and breast imaging
* Women with dense breast
* Women in high risk for Breast Cancer

Before the imaging procedure each woman will need to fill detailed questionnaire, specific for the study, that will include information on her medical history, family history, gynecology information, menstrual phase, use of hormones etc.

The images will be correlated with other imaging tests including mammography, US and MRI. We will follow up the women for at least 6 months, including biopsy findings and or other clinical and imaging exams.

This phase will include 500 women.

Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions

Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions.

Tel-Aviv Sourasky Medical Center

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Radiopharmaceuticals

This is a prospective study evaluating the role of Positron Emission Tomography (PET scan) in breast cancer. The radiopharmaceutical \[18F\] 2-deoxyglucose will be used as both an imaging modality and to evaluate tumor metabolism in patients with breast cancer. Patients with stage II, stage IIIA or IIIB, or stage IV breast cancer and evaluable disease in the breast and/or at metastatic sites will be studied. Patients will be injected intravenously with \[18F\]2-deoxyglucose and a PET scan conducted over 90 minutes. Examination of the role of PET scan in assessing the response of breast cancer to chemotherapy, especially in stage II and stage III patients, will be done. Up to three PET scans within one year may be performed. Findings by PET scan will be correlated both with those of concurrent imaging techniques (x-ray, CT scan, MRI, bone scan or mammogram), and with histologic, biochemical, and flow cytometric information on the tumor, and with findings in subsequent surgical specimens. Changes in tumor glucose metabolism with treatment will be assessed by PET imaging studies and by biochemical methods when possible.

Positron Emission Tomography in Patients With Breast Cancer

National Cancer Institute (NCI)

Diseases and Abnormalities at or Before Birth

Congenital Abnormalities

Technetium Tc 99m Sestamibi

Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study.

Patients receive technetium Tc-99m sestamibi IV and undergo MBI. Patients whose breast lesions of interest are visualized on MBI then undergo breast biopsy using the Stereo Navigator accessory.

Biopsy of Breast

Utilization of the Stereo Navigator accessory

Medical Device Usage and Evaluation

Scintimammography

Technetium Tc-99m Sestamibi

Clinical Trials Referral Office

Katie N. Hunt, M.D.

This clinical trial tests how well molecular breast imaging (MBI) works to guide the collection of a breast biopsy in patients with a breast abnormality. Currently, a biopsy is often guided by either ultrasound or mammography in order to ensure that a sample of the correct part of the breast is taken. Sometimes a lesion or part of the lesion cannot be seen on ultrasound or mammography, and, therefore, a biopsy guided with ultrasound or mammography may not be always be accurate. Studies have shown that high resolution MBI may have potential to improve the detection of some breast tumors. This trial uses a new high-resolution MBI system that may help perform a biopsy using MBI.

PRIMARY OBJECTIVE:

I. To evaluate a methodology for MBI-guided biopsy of suspicious breast lesions.

OUTLINE: Patients are assigned to 1 of 2 study parts.

PART I: Patients receive technetium Tc-99m sestamibi intravenously (IV) and undergo MBI on study.

PART II: Patients receive technetium Tc-99m sestamibi IV and undergo MBI. Patients whose breast lesions of interest are visualized on MBI then undergo breast biopsy using the Stereo Navigator accessory.

After completion of study intervention, patients may be asked to follow up at 3-6 months.

Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities

Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities

Time from injection of the technetium Tc-99m sestamibi to identification of the appropriate needle guide hole will be reviewed to determine if and where any improvements in workflow can be made to reduce the overall procedure time for patients.

The coordinates of the lesion of interest on the high resolution MBI image will be recorded. The guidance procedure will be considered successful if 1) the pre and post images of the lesion demonstrated one of the following: decreased in size, central or eccentric defect where sampled, or decrease in intensity, or 2) pathology results demonstrate malignancy or a specific benign concordant result.

For each patient in whom pathology confirms successful sampling of the lesion seen on high-resolution molecular breast imaging (MBI), the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.

For each patient in whom pathology confirms successful sampling of the lesion seen on MBI, the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.

Mayo Clinic

Carcinoma

Participants undergo DBT and MBI at year 0 and year 1 screening.

Digital Tomosynthesis Mammography

Carrie B. Hruska, M.D.

This study compares molecular breast imaging (MBI) and digital breast tomosynthesis (DBT) in screening patients with dense breast tissue. Breast imaging may help doctors find breast cancer sooner, when it may be easier to treat. Molecular breast imaging (MBI) uses an injection of a small amount of radioactive material that is taken up in tissues of the body that are actively changing, such as breast cancer. A specialized camera, called a gamma camera, takes pictures of the gamma rays emitted by this material. MBI may detect cancers that are not visible on mammograms. This study may help researchers determine how MBI testing compares to DBT screening.

PRIMARY OBJECTIVE:

I. To compare the rate of detection of invasive cancers between digital breast tomosynthesis (DBT) alone versus (vs.) the combination of DBT with supplemental MBI at year 0 screening.

SECONDARY OBJECTIVES:

I. To compare the invasive cancer detection rates of DBT alone vs. MBI alone at year 0 screening.

II. To compare the screening performance metrics of sensitivity, specificity, recall rate, biopsy rate, positive predictive value and negative predictive value for DBT and MBI.

III. To compare tumor characteristics of all cancers (invasive and noninvasive) detected on DBT and MBI, including size, nodal status, and molecular subtype.

IV. To assess the reduction in advanced cancer rate with incorporation of MBI screening by comparing advanced cancer rate observed at year 1 screening relative to that at year 0.

V. To assess the rate of interval cancers with incorporation of MBI screening. VI. To examine the relative performance of DBT and MBI within subgroups categorized by breast cancer risk.

OUTLINE:

Participants undergo DBT and MBI at year 0 and year 1 screening.

Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients With Dense Breast Tissue

Density MATTERS [Molecular Breast Imaging (MBI) And Tomosynthesis To Eliminate the ReServoir]

Will compare the rate of detection of invasive cancers between DBT alone versus (vs.) the combination of digital breast tomosynthesis (DBT) with supplemental molecular breast imaging (MBI) at year 0 screening. For each modality, the detection rate of invasive cancers will be estimated as the proportion of participants in the analysis set who had an invasive cancer detected by the modality and verified by pathology. Because of the paired design, the primary comparison of the invasive cancer detection rates will be made using a 2-sided McNemar's test at statistical significance level alpha= 0.05.

Will compare the rate of detection of invasive cancers between DBT alone vs. MBI alone at Year 0 screening. The comparison will be based on a 2-sided McNemar's test at statistical significance level alpha= 0.05.

Sensitivity will be estimated for each modality as the proportion of women with breast cancer who have true positive test results. Will be analyzed to compare performance of DBT alone vs. MBI alone, and DBT alone vs. the combination of DBT with supplemental MBI. Uncertainty in the estimate of sensitivity will be quantified through a two-sided 95% confidence interval (CI) based on the binomial distribution. If a sufficient number of radiologists interpret exams from multiple patients with breast cancer, secondary analysis may also include a 95% CI and chi-squared test adjusted for clustering of results within radiologist to allow generalization to both the population of patients and the population of radiologists.

Specificity will be estimated as the proportion of women without breast cancer who have TN test results. Will be analyzed to compare performance of DBT alone vs. MBI alone, and DBT alone vs. the combination of DBT with supplemental MBI.

Recall rate (defined as the proportion of patients recalled from the screening test for diagnostic workup among the total number of patients screened) will be estimated employing analytical strategies similar to sensitivity and specificity. McNemar's test will be used to compare rates between two modalities. Will be analyzed to compare performance of DBT alone vs. MBI alone, and DBT alone vs. the combination of DBT with supplemental MBI.

Biopsy rate (defined as the proportion of patients in whom biopsy is generated from a particular modality among the total number of patients screened) will be estimated employing analytical strategies similar to sensitivity and specificity. McNemar's test will be used to compare rates between two modalities. Will be analyzed to compare performance of DBT alone vs. MBI alone, and DBT alone vs. the combination of DBT with supplemental MBI.

Predictive values will be estimated for each modality based on data pooled across radiologists. Positive predictive value (PPV)1 (the proportion of patients with breast cancer among patients with abnormal screening examinations), PPV3 (the proportion of breast cancers diagnosed among biopsies performed), and negative predictive value (NPV) (the proportion of patients without breast cancer among those with normal screening examinations) will be determined. Will be analyzed to compare performance of DBT alone vs. MBI alone, and DBT alone vs. the combination of DBT with supplemental MBI.

Will compare tumor characteristics of all cancers (invasive and noninvasive) detected on DBT and MBI, including size, nodal status, and molecular subtype. The analysis comparing tumor characteristics will be descriptive. Size, nodal status, and molecular subtype (including estrogen and progesterone receptor status, HER-2 status, Ki-67 and Oncotype DX score as available) will be abstracted from clinical final pathology reports from all biopsies and surgeries performed. The distribution of sizes will be summarized by ordinary numeric (e.g., means, standard deviations \[SDs\], range) and graphical (e.g., histograms, density smoothers) summaries. Descriptive summaries of the lesions identified with MBI but not DBT and vice versa will also be calculated to understand the differences in performance should one be identified.

Will assess whether the incorporation of MBI screening reduces advanced cancer rate, the rate of advanced cancers detected at Year 1 screening will be compared to the rate at Year 0 screening. The rates of advanced cancers, together with their respective 95% confidence intervals, will be estimated for Year 0 and Year 1. Comparison in the rates between Year 0 and Year 1 will utilize the test of two proportions based on exact binomial distributions.

We will estimate the rate of interval cancers from our study and provide a 95% confidence interval.

The relative performance of the screening modalities (sensitivity and specificity) will be characterized separately, within subgroups of patients defined by various levels of risk. The statistical power to discern differential performances of the screening modalities among different risk subgroups may be limited due to the restricted sample size in these subgroup analyses.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions	NCT01004666	Small Breast Le... Dense Breast Ti... Discrepancy Wit... Equivocal Mammo...		25 Years -	Tel-Aviv Sourasky Medical Center
Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions	NCT01004666	Small Breast Le... Dense Breast Ti... Discrepancy Wit... Equivocal Mammo...		25 Years -	Tel-Aviv Sourasky Medical Center
Positron Emission Tomography in Patients With Breast Cancer	NCT00001385	Breast Neoplasm...		-	National Institutes of Health Clinical Center (CC)
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities	NCT06058650	Breast Neoplasm	Biopsy of Breas... Medical Device ... Scintimammograp... Technetium Tc-9...	18 Years -	Mayo Clinic
Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients With Dense Breast Tissue	NCT03220893	Breast Carcinom...	Digital Tomosyn... Scintimammograp...	40 Years - 75 Years	Mayo Clinic
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities	NCT06058650	Breast Neoplasm	Biopsy of Breas... Medical Device ... Scintimammograp... Technetium Tc-9...	18 Years -	Mayo Clinic
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities	NCT06058650	Breast Neoplasm	Biopsy of Breas... Medical Device ... Scintimammograp... Technetium Tc-9...	18 Years -	Mayo Clinic

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