Place: Davangere Date:
From,
Dr. Dhruva Rajgopal
Post Graduate Student in M.D.
Dept. of Radio-Diagnosis,
S S Institute of Medical Sciences, Davangere
To,
The Principal,
S S Institute of Medical Sciences and Research Centre,
Davangere
THROUGH PROPER CHANNEL
Respected sir,
Subject: Acceptance of registration and forwarding of dissertation topic,
In accordance with the above cited subject, I undersigned studying Post Graduate Course in M.D. Radio-Diagnosis have been allotted the dissertation topic“EVALUATION OF BREAST LUMP WITH SONOMAMMOGRAPHY OF BREAST AND MRI OF BREAST WITH DYNAMIC CONTRAST.”under the guidance of ASSOC. PROFESSOR,DR.Parthasarathi, Departmentof Radio-diagnosis, SSIMS and RC, Davangere.
I request you to kindly forward the dissertation topic in the prescribed form to the University for approval.
Thanking you,
Yours faithfully,
Dr. Dhruva Rajgopal
Signature of the guide
Dr.PARTHASARATHI
Assoc. Professor,
Department ofRadio-Diagnosis,
SS Institute of Medical Sciences and Research Centre.
Place: Davangere
Date:
From,
The Assoc.Professor,
Department ofRadio-Diagnosis,
SS Instituteof Medical sciences and Research Centre
Davangere.
To,
The Registrar,
Rajiv Gandhi University of Health Sciences,
Bangalore.
THROUGH PROPER CHANNEL
Respected sir,
As per the regulations of the University of registration of Dissertation topic, the Official Registration Committee of all qualified and eligible guides of the Department of Radio-Diagnosis has allotted the following Post Graduate in M.D. Radio-Diagnosis the dissertation topic as.
NAME / TOPIC / GUIDEDr.Dhruva Rajgopal
Post Graduate Student in M.D.
Dept. of Radio-Diagnosis, SSIMS & RC, Davangere. / “EVALUATION OF BREAST LUMP WITH SONOMAMMOGRAPHY OF BREAST AND MRI OF BREAST WITH DYNAMIC CONTRAST.” / DR.Parthasarthi
Assoc. Professor Dept.of Radio-Diagnosis,
SSIMS & RC,Davangere.
Therefore, I kindly request you to communicate the acceptance of the dissertation topic allotted to the PG student at an early date.
Thanking you,
Yours faithfully,
Signature of the guide
Dr.PARTAHSARTHI
Associate Professor in Radio-Diagnosis,
Department of Radio-Diagnosis,
SSIMS and RC, Davangere.
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE
ANNEXURE—II
PROFORMA FOR REGISTRATION OF SUBJECT FOR
DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS (in block letters) / Dr. DHRUVA RAJGOPAL3127/A ‘SWARA’ 2nd CROSS SOUTHERN EXTENSION
KOLLEGAL-571440
KARNATAKA.
2. / NAME OF THE INSTITUTION / SS INSTITUTE OF MEDICAL SCIENCESAND RESEARCH CENTRE, DAVANGERE.
3. / COURSE OF STUDY AND SUBJECT / MD RADIO-DIAGNOSIS
4. / DATE OF ADMISSION TO THE COURSE / 04-06-2012
5. / TITLE OF THE TOPIC:“EVALUATION OF BREAST LUMP WITHSONOMAMMOGRAPHY OF BREAST AND MRI OF BREAST WITH DYNAMIC CONTRAST.”
6. / BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
The incidence of breast cancer is rising in every country of the world especially in developing countries such as India. Breast cancer is the most commonly occurring female cancer in the world with an age-standardized incidence rate (ASR) of 39.0 per 100,000, which is more than double that of the second ranked cancer (cervical cancer ASR=15.2 per 100,000)(1,2). This is because more and more women in India are beginning to work outside their homes, which allow the various risk factors of breast cancer to come into play. These include late age at first childbirth, fewer children and shorter duration of breast-feeding etc.
In-spite of medical advances and assuring treatment regime, a reduction in morbidity and mortality due to breast cancer has seen no significant changes in India. This may be due to lack of systematic screening and early detection of the condition. Hence early detection by imaging modality comes handy in determining the progression of the disease.
In the past decades, great strides have been made in breast cancer screening. The combination of imaging, clinical examination and needle biopsy- known as triple assessment, is the expected standard for breast diagnosis(3). While multiple studies have shown the benefits of screening mammography, there are limitations on X-ray mammography. Given this inherent limitation, efforts have been made to develop several adjuvant-imaging techniques.
In this study the sensitivity of the mammography, ultrasound of breast and MRI of breast with dynamic contrast are compared. With the use of gadolinium-based intravenous contrast agents, the sensitivity of MR imaging for invasive breast cancer approaches 100% (4). With the help of dynamic curves, comment on the nature of the breast lesion can be done. In this study the MRI sensitivity is compared with the USG and mammography combined in detecting the outcome of a breast lump. If the present study justifies, then MRI of breast could be included in the standard screening of the breast lump, especially in suspected cases of breast cancer. This could avoid painful interventional procedures like FNAC and core biopsy.
6.2 REVIEW OF LITERATURE:
1) Katarzyna. J. Macura (et all) (2006) have conducted a study on the role of dynamic contrast material– enhanced magnetic resonance (MR) imaging of the breast as an adjunct to the conventional techniques of mammography and ultrasonography. The margin characteristics of a lesion and the intensity of its enhancement at MR imaging 2 minutes or less after contrast material injection are demonstrated as the currently considered most important features for breast lesion diagnosis. (5)
2) E. Warner (et all) (2001) have conducted a comparative study in which they have compared breast magnetic resonance imaging (MRI) with ultrasound, mammography, and physical examination in women at high risk for hereditary breast cancer. They have described that although the recommended surveillance for BRCA1 and BRCA2 mutation carriers includes regular mammography and clinical breast examination, the effectiveness of these screening techniques in mutation carriers has not been established. A total of 196 women, aged 26 to 59 years, with proven BRCA1 or BRCA2 mutations or strong family histories of breast or ovarian cancer underwent mammography, ultrasound, MRI, and clinical breast examination on a single day. A biopsy was performed when any of the four investigations was judged to be suspicious for malignancy. They concluded that breast MRI might be superior to mammography and ultrasound for the screening of women at high risk for hereditary breast cancer.(6)
3) Kjell A. Kvistad, MD (et all) conducted a study to evaluate the diagnostic value of an imaging protocol that combines dynamic contrast-enhanced T1-weighted magnetic resonance (MR) imaging and T2-weighted first-pass perfusion imaging in patients with breast tumors and to determine if T2-weighted imaging can provide additional diagnostic information to that obtained with T1-weighted imaging. 130 patients with breast tumors underwent MR imaging with dynamic contrast-enhanced T1-weighted imaging of the entire breast, which was followed immediately with single-section, T2- weighted imaging of the tumor. They concluded that T2-weighted first-pass perfusion imaging could help differentiate between benign and malignant breast lesions with a high level of specificity. The combination of T1-weighted and T2-weighted imaging is feasible in a single patient examination and may improve breast MR imaging.(7)
4) Sabine Malur (et all) (2000) conducted a study in which patients with abnormal breast findings (n=413) were examined by mammography, sonography and magnetic resonance (MR) mammography; 185 invasive cancers, 38 carcinoma in situ and 254 benign tumors were confirmed histologically. Sensitivity for mammography was 83.7%, for sonography it was 89.1% and for MR mammography it was 94.6% for invasive cancers. In 42 patients with multifocal invasive cancers, multifocality had been detected by mammography and sonography in 26.2%, and by MR mammography in 66.7%. In nine patients with multicentric cancers, detection rates were 55.5, 55.5 and 88.8%, respectively. Carcinoma in situ was diagnosed by mammography in 78.9% and by MR mammography in 68.4% of patients. They concluded that combination of all three diagnostic methods lead to the best results for detection of invasive cancer and multifocal disease.(8)
5) Eren Yeh (et all) (2005) conducted a study with an objective to determine the relative accuracy of mammography, sonography, and MRI in predicting residual tumor after neoadjuvant chemotherapy for breast cancer as compared with the gold standards of physical examination and pathology. Forty-one women with stage IIB–III palpable breast cancers were prospectively enrolled in a study investigating the effects of sequential single- agent chemotherapy (doxorubicin followed by paclitaxel or vice versa) on tumor imaging. The study cohort consisted of the first 31 patients (age range, 31–65 years; mean, 45 years) who completed the protocol. All underwent physical examination, mammography, sonography, and MRI before and after receiving each neoadjuvant chemotherapeutic drug. Two radiologists using conventional lexicons for lesion analysis reviewed imaging studies and the findings were compared with clinical response and pathology results. They concluded that MRI appears to provide the best correlation with pathology better than physical examination, mammography, and sonography in patients undergoing neoadjuvant chemotherapy.(9)
6) Sughra Raza (et al) (2010) have described the Breast Imaging Reporting and Data System (BI-RADS) lexicon for ultrasonography (US) which is based on the established lexicon used successfully in mammography and attempts to provide a common language to avoid ambiguity in interpreting, reporting, and teaching breast US. Proper and consistent use of the BI-RADS US lexicon has numerous advantages, including facilitating (a) communication of final assessment categories that clearly indicate management recommendations, (b) data tracking for self-audits, and (c) clinical review of outcome summaries. Berg et al (2), reporting on 11 experienced examiners’ performances in an experimental setting, found moderate agreement for the final assessment (k = 0.52) and fair agreement for the echo pattern (k = 0.25). Lazarus et al (3) showed fair inter-observer agreement (k = 0.29) for the lesion echo pattern and moderate agreement for the lesion margin and posterior acoustic features (k = 0.40 for both). Most recently, Abdullah et al (4) showed fair inter-observer agreement (k = 0.36) in the evaluation of lesion margins, particularly non-circumscribed margins. The results of the study by Abdullah et al (4) also showed low inter-observer agreement for evaluation of small masses and poor reproducibility of the BI-RADS category 4 subdivisions.
Although some of this variability may rest with operator technique, which presents inherent challenges for US as a modality in general, some of this disparity arises from fundamental differences in lesion interpretation. Interpretations may be influenced by the level of training or experience of the radiologist or may arise from confusion about the use of the BI-RADS US lexicon. (10)
6.3 OBJECTIVES OF THE STUDY:
1)To compare the sensitivity of dynamic contrast MRI of breastand sonomamoography in determining the benign/malignant nature of breast lesions in patients belonging to BI-RADS category 3,4 and 5.
2) To correlate the imaging findings with histopathological findings.
7. / MATERIALS AND METHODS
7.1 Source of data:
Hospital attached to SS Institute of Medical Sciences & Research Centre
7.2 Methods of collecting data:
Duration of the study: November 2012 to May 2014.
Sample size: 30 cases are considered for the study but the scope for increasing the sample size is also considered depending upon the availability.
Design: Comparative study.
Statistical analysis:
The data will be analyzed by calculating the sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of the techniques.
Inclusion criteria:
- Patients with clinically palpable breast lump
- Patients belonging to BI-RADS category 3, 4 and 5.
BI-RADS
US Category / Assessment and Management
0 / Incomplete: additional imaging evaluation needed
1 / Negative
2 / Benign
3 / Probably benign: short-interval follow-up recommended
4
4a
4b
4c / Suspicious: biopsy
Low suspicion
Intermediate suspicion
Moderate suspicion
5 / Highly suggestive of malignancy: biopsy
6 / Know malignancy: treatment ongoing
Exclusion criteria:
- Patient belonging to BI-RADS category 1, 2 and 6.
Patients will be selected according of the inclusion criteria. Informed written consent will be taken form each patient under the study. Under the guidance of my guide and co-guide Ultrasonography of the breast will be done in GE Voluson 730 equipment, using a high frequency (12MHz) linear probe.Mammography will be done in patients wherever required .MRI of the breast will be done on GE Signa HDxt 1.5 T machine. HD 8 channel VIBRANT breast array coil fromGE is used in all patients. Axial T1 and T2, axial fat saturation STIR T2, sagittal T2 fat saturation of each breast, axial DWI, sagittal/axial with dynamic contrast multiphase, spectroscopy of the breast, signal enhancement ratio and post contrast subtraction images were done. Additional sequences are done depending upon the case requirement.Finally FNAC/Core biopsy of the lesion will be done and the histo-pathological report assessment will be done to compare the findings of MRI with that of histo-pathological analysis and the comparative findings are documented. Observation are done for the following:
Primary outcome:
- Morphology of the lesion is analysed on MRI and sono-mammography.
- Enhancement of the lesion of the breast on MRI.
- Nature of the dynamic curves on signal enhancement ratio (SER).
- Nature of the lesion on Mammography where ever done.
- Side effects at the time of injection of contrast (anaphylactic reaction, cardiac arrhythmia, hypotension and extravasation).
- Bleeding at the site of FNAC/Core biopsy.
-YES,our study requires interventions likeIntra Venous cannula insertion for contrast injection and FineNeedle Aspiration Cytology/Core Biopsyfor histo-pathological study.
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3
-Yes
8. / LIST OF REFERENCES:
1)Ferlay J BF, Pisani P, Parkin DM. Globocan 2000: Cancer Incidence, Mortality and Prevalence Worldwide, Version 1.0. 2001.
2)Ferlay J SH, Bray F, Forman D, Mathers C and Parkin DM. Globocan 2008 v 1.2, Cancer Incidence and Mortality Worldwide: IARC Cancer base No. 10 [Internet]. 2010.URL:
3)Jonathan J. James, Robin M, James A. Adam: Grainger & Allison’s Diagnostic Radiology, 5th edition: Elsevier.Inc., 2008;2:1173-1216.
4)Susan Weinstein, Mark Rosen. Breast MR Imaging: Current Indications and Advanced Imaging Techniques. Radiol Clin N Am 48 (2010):1013-42
5)Katarzyna J. Macura, Ronald Ouwerkerk, Michael A. Jacobs, David A. Bluemke. Patterns of Enhancement on Breast MR Images: Interpretation and Imaging Pitfalls. RadioGraphics 2006; 26:1719 –34
6)E. Warner, D.B. Plewes, R.S. Shumak (et al). Comparison of Breast Magnetic Resonance Imaging, Mammography, and Ultrasound for Surveillance of Women at High Risk for Hereditary Breast Cancer. Journal of Clinical Oncology, Vol 19, No 15 (August 1), 2001:3524-53.
7)Eren Yeh,Priscilla Slanetz, Daniel B. Kopans (et al).Prospective Comparison of Mammography, Sonography, and MRI in Patients Undergoing Neoadjuvant Chemotherapy for Palpable Breast Cancer. AJR 2005; 184:868–77.
8)Sabine Malur, Susanne Wurdinger, Andreas Moritz (et al). Comparison of written reports of mammography, sonography and magnetic resonance mammography for preoperative evaluation of breast lesions, with special emphasis on magnetic resonance mammography. Breast Cancer Res 2001, 3:55–60.
9)Kell A. Kvistad, Jana Rydland, Jari Vainio (et al). Breast lesions: Evaluation with dynamic contrast enhanced T1 weighted MR images and T2 weighted first pass perfusion MR images. Radiology 2000. 216:545-53.
10)Sughra Raza, Allison L Goldkamp, Sona A Chikarmane, Robyn L Birdwell. US features of Brest masses categorized as BI-RADS 3,4and 5: pictorial review of factors influencing clinical management. Radiographics 2010. 30:1199-213.
9. / SIGNATURE OF THE CANDIDATE: / Dr. DHRUVA.RAJGOPAL
10. / REMARKS OF THE GUIDE: / RECOMMENDED AND FORWARDED FOR THE NEEDFUL.
11. / NAME AND DESIGNATION OF
(In block letters)
11.1 GUIDE
SIGNATURE
11.2 CO.GUIDE
SIGNATURE
SIGNATURE
11.3HEAD OF THE DEPARTMENT:
SIGNATURE / Dr.PARTHASARATHI
MBBS, MDRD, DMRD.
1) Dr.KISHAN A BHAGWATH
MBBS, MDRD, DNB.
2) Dr. LINGANAGOWDA S PATILMBBS, MS, MCH.
Dr.RAMESH S DESAI
MBBS, MDRD, DMRD.
12. / 12.1 REMARKS OF THE CHAIRMAN & PRINCIPAL
PRINCIPAL:
SIGNATURE / RECOMMENDED AND FORWARDED FOR THE NEEDFUL.
Dr. NAGARAJ. P
MBBS, MS.