Date: 19TH OCTOBER 2012
From,
Dr. ARUN.P.AJITH
Post Graduate,
Department of Radiodiagnosis,
A.J.Institute of Medical Sciences,
Kuntikana, Mangalore.
To,
The Chairman/ Member Secretary
Institute Ethics Committee,
A.J.Institute of Medical Sciences,
Kuntikana, Mangalore.
Through the Head of the department of Radiodiagnosis
Subject: Submission of synopsis to Ethical committee-reg
I am herewith submitting my MD dissertation synopsis titled “ROLE OF T2-WEIGHTED AND DIFFUSION-WEIGHTED MRI FOR EVALUATION OF PROSTATE CANCER” for the consideration of the Institute Ethics committee. I have also enclosed the proforma for the ethics committee, data collection proforma, consent form and curriculum vitae. I request you to kindly do the needful.
Thanking you
Yours sincerely
Dr ARUN.P.AJITH
Encl: as above
Proforma to be filled by the Principal Investigator (PI) for submission to Institutional Ethics Committee (IEC)
(for attachment to each copy of the proposal)
Serial No of IEC Management Office:Proposal Title: “ROLE OF T2-WEIGHTED AND DIFFUSION-WEIGHTED MRI FOR EVALUATION OF PROSTATE CANCER”
Name, DesignationQualifications / Address
Tel & Fax Nos.
Email ID / Signature
Principal Investigator
Guide / Dr. ARUN.P.AJITH
postgraduate,
Dept.of radiodiagnosis
A.J.Institute of Medical Sciences.
M.B.B.S
Dr. PRAVEEN KUMAR JOHN
Assoc.Professor
Dept. of Radiodiagnosis
A.J.Institute of Medical Sciences.
M.B.B.S, D.N.B, D.M.R.D / Ward/ 9, 346, T.B. Road, Mission Quarters, Thrissur, Kerala.
Ph: 9900416567
Flat No. 605 , Plama Residency Kottara Cross , Bejai, Mangalore, Karnataka
Ph : 9845214851
Curriculum Vitae of principal investigator and the guide (with subject specific publications limited to previous 5 years) – attached
1.Type of Study: prospective study
2: Brief description of the proposal: The aim of this study is to evaluate the role of T2 weighted imaging, diffusion-weighted imaging and the combination of these magnetic resonance techniques in the detection and localization of prostate cancer. The early detection, characterization and localization of prostate lesions will help in the management of prostate carcinoma and also helps so that definitive treatment can be initiated in early stages
3. Subject selection:
i. Number of Subjects : minimum of 30
ii. Duration of study : 2 years
iii. Will subjects from both sexes be recruited: / No , only males
iv. Inclusion / exclusion criteria given: / Yes
v. Type of subjects: patients presenting in the department with suspected prostate carcinoma covered under the inclusion criteria will be included as study group.
4. Privacy and confidentiality
Confidential handling of data : Yes
5. Consent : Please find it attached written informed consent
i. Consent form : (included elements)
1. Understandable language
2. Statement that study involves research
3. Statement that consent is voluntary
4. Purpose and procedures
5. Risks & Discomforts
6. Benefits
7. Confidentiality of records
8. Right to withdraw
9. Contact information
ii. Who will obtain consent – Principal investigator
6. Will any advertising be done for recruitment of Subjects?
(posters, flyers, brochure, websites – if so kindly attach a copy) / No
7. Risks & Benefits: No risks, but benefits to the research world
8. Is there compensation for participation? / No
Checklist for attached documents:
1. Project proposal – 2 Copies
2. Curriculum Vitae of Investigators
3. Curriculum Vitae of Guide
4. Informed Consent form
5. Copy of data collection Proforma
Place: Signature & Designation Date: of Principal investigator
CURRICULUM VITAE
Name : Dr.ARUN.P.AJITH
Date of Birth &Age : 29TH March 1986. 26 year
Present Designation : PG/Junior Resident
Department : Radiodiagnosis
College : A. J. Institute of Medical Sciences
City : Mangalore
Residential address : Ward / 9, 346, T.B Road,
Mission Quarters, Thrissur, Kerala
Phone : Residence: 0487-2429660
Mobile: 9900416567 Email :
Qualification:
Qualification / College / University / Year / Registration number of UG & PG with date / Name of the state Medical CouncilMBBS / Jubilee mission medical college research institute, thrissur, kerala / Calicut university / 2010 / 94985 26/03/2012 / Karnataka Medical Council
Details of the previous appointments/ teaching experience:
Designation / Department / Name of Institution / From DD/MM/YY / To DD/MM/YY / Total experience in years and monthsPG/ Jr. Resident / Radiodiagnosis / A. J. Institute of Medical Sciences, Mangalore / May 22 2012 / Till Date
CURRICULAM VITAE
Name : DR.PRAVEEN KUMAR JOHN
Date of Birth & Age : 15th May 1974. 38 year
Present Designation : Associate Professor
Department : Radiodiagnosis
College : A.J. Institute of Medical Sciences
City : Mangalore
Residential Address : Flat No. 605, Plama Residency,
Kottara Cross, Bejai, Mangalore, Karnataka
Phone :
Residence: 91-824-2221269
Mobile : 9845214851
Email :
Qualifications:
Qualification / College / University / Year / Registration No.of UG & PG with Date / Name of the State Medical CouncilMBBS / Kasturba medical college, Mangalore / MAHE, Manipal / March 1997 / 45735 March 25 1997 / Karnataka medical Council
D.M.RD / Kasturba medical college, Manipal / MAHE, Manipal / December 1999 / 45735 March 25 1997 / Karnataka Medical Council
D.N.B / Father Muller Medical College, Mangalore / National Board of examination / October2002 / 45735 December 16 2003 / Karnataka Medical Council
Date of joining Present Institution: October 20th, 2004
Details of the previous appointments/teaching experience
Designation / Department / Name of Institution / FromDD/MM/YY / To
DD/MM/YY / Total Experience in years& months
Resident / Radiodiagnosis / Kasturba medical college, Manipal / August 1997 / December 1999 / 2 Years 5 Months
Tutor / Radiodiagnosis / Father muller medical college, Mangalore / March 2000 / February 2002 / 2 years
Senior Resident / Radiodiagnosis / Father muller medical college, Mangalore / March 2002 / October 2002 / 8 Months
Research Fellow / Radiodiagnosis / Father muller medical college, Mangalore / November 2002 / October 2003 / 1 Year
Assistant professor / Radiodiagnosis / Father muller medical college, Mangalore / November 2003 / October 2004 / 5 months
Assistant professor / Radiodiagnosis / A J Institute of medical sciences, Mangalore / October 2004 / August 2010 / 5 years 9 months
Associate professor / Radiodiagnosis / A J Institute of medical sciences, Mangalore / August 2010 / Till date
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
SYNOPSIS
“ROLE OF T2-WEIGHTED AND DIFFUSION-WEIGHTED MRI FOR EVALUATION OF PROSTATE CANCER”
NAME OF THE
CANDIDATE: DR. ARUN.P.AJITH
GUIDE: DR. PRAVEEN KUMAR JOHN D.N.B, D.M.R.D,
COURSE AND SUBJECT: M.D (RADIO-DIAGNOSIS)
DEPARTMENT OF RADIODIAGNOSIS
A J INSTITUTE OF MEDICAL SCIENCES,
KUNTIKANA, MANGALORE - 575004
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE
BANGALORE, KARNATAKA.
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION.
1. / NAME OF THE CANDIDATE AND ADDRESS [IN BLOCK LETTERS] / DR. ARUN.P.AJITHPOST GRADUATE STUDENT,
DEPARTMENT OF RADIODIAGNOSIS,
A. J.INSTITUTE OF MEDICAL SCIENCES,
MANGALORE - 575004
2. / NAME OF THE INSTITUTION / A J INSTITUTE OF MEDICAL SCIENCES
3. / COURSE OF STUDY AND SUBJECT / DOCTOR OF MEDICINE (M.D)
RADIO-DIAGNOSIS
4. / DATE OF ADMISSION TO THE COURSE / 22nd may 2012
5. / TITLE OF THE TOPIC: “ROLE OF T2-WEIGHTED AND DIFFUSION-WEIGHTED MRI FOR EVALUATION OF PROSTATE CANCER”
BRIEF RESUME OF THE INTENDED WORK:
NEED FOR THE STUDY:
Prostate cancer is the seventh most common cancer in males in India. Its mortality in India is 2.5/100,000.Clinically the patients with prostate cancer in early stages are asymptomatic; in later stages symptoms include hematuria, urgency, nocturia , frequency, hesitancy and bone pain if there is metastasis.
Digital rectal examination (DRE) and prostate specific antigen (PSA) are two commonly used clinical and biochemical parameters for evaluation of patients suspected of cancer prostate on the basis of above symptoms. Digital rectal examination (DRE) is the primary method of examination of the prostate. However DRE is a subjective test and has limitations. Not all prostate malignancies are palpable on DRE.DRE fails to detect a significant number of malignancies, and of those when it does detect, a significant number are already at an advanced stage.
PSA level is often the first to rise in cancer prostate. Its Normal value is <4ng/ml and level above 10 ng/ml indicates the need for biopsy. However level of 4 to 10 ng/ml is considered inconclusive. Moreover it is not a specific marker of prostatic cancer. Its level rises in prostatic inflammation and benign prostatic disease as well. However, measurement of PSA levels often leads to over diagnosis of even small cancer which would not have caused any symptoms in the lifetime of an individual. Therefore although estimation of PSA level is a good screening test for prostatic cancer, it has a low sensitivity and specificity.
Transrectal ultrasound (TRUS) is the primary imaging modality for evaluation of both benign and malignant disease of prostate. It has sensitivity of 86.96% and its specificity is 71.43% for detection of prostate cancer. Although TRUS has an important role in transrectal biopsy, it is only moderately sensitive for staging of prostate cancer. Further it is not used for staging of disease because there is significant inter observer variation. TRUS also has limitation in detection of cancer in transtitional zone and for detection of extracapsular spread.
The management of patients with prostate cancer depends on the tumor volume, seminal vesicle involvement and extracapsular spread. In view of limitations seen with PSA, DRE and TRUS, MRI is the evolving modality of choice for evaluation of prostate cancer. Conventionally T2W scan sequences are used for detection and staging of prostate cancer. T2W imaging has been used widely for pre-treatment work-up of prostatic cancer. The sensitivity and specificity of T2W scans for prostatic cancer detection is variable. However, recent studies have shown that T2W imaging has limited value in detecting cancer in central gland because of poor morphological difference between cancer tissue and native gland. T2WI has limitation in detection of cancer in transitional, central zones and also low signal intensity on T2W scan can be due to noncancerous conditions, such as hemorrhage, post radiation fibrosis and non specific inflammation, to overcome the limitation of conventional MRI, use of diffusion Weighted and Dynamic MRI is being evaluated. Many studies have reported that additional MRI methods, such as diffusion weighted imaging (DWI) and dynamic contrast enhanced imaging (DCE-MRI), can offer additional value in localizing cancer. These MRI techniques are also helpful in determining the presence or absence of extracapsular extension and seminal vesicle invasion. Furthermore, additional MRI methods performed before repeat biopsy are useful for detecting prostate cancer in patients with a negative transrectal ultrasound–guided biopsy but a persistently high prostate specific antigen (PSA) level.
REVIEW OF LITERATURE
Gibbs et al1 in year 2001 successfully investigated T2 relaxation rate and DWI of human prostate using phase array coil. Mean ADC for normal and malignant peripheral zone were obtained. The author concluded that prostate cancer can cause restricted diffusion of water relative to normal tissue, resulting in decreased signal in malignant lesions on ADC map.
In the year 2002 Issa2 conducted a study to measure the apparent diffusion coefficient (ADC) value at which prostatic cancer and normal prostatic tissue can be differentiated. They found that the ADC value for normal PZ was higher than for CG and cancer in PZ. They concluded that the ADC value is lower for prostatic cancer than for normal tissue.ADC value for normal peripheral zone was 1.9x10-3and for cancer prostate in peripheral zone was 1.32x10-3.
Study was done by Haider3 in 2007 on 49 patients with prostate cancer to compare T2W MRI alone and T2 combined with DWI. Patients underwent staging MRI before radical prostatectomy and at least weeks after biopsy. Each lesion was given score from 0-5 ranging from definitely no cancer to definitely cancer images looking at only T2WI first thenT2WI+ADC. T2WI and T2+DWI were scored for likely of tumor and were compared with whole mount histological result. They concluded that sensitivity for T2W+DWI was 81% as compared to 54% for T2W scan.
Study was done by Woodfield4 in 2009 to find the visibility of prostatic tumor on DWI in relation to Gleason score. The imaging results were compared to histopathology data. They concluded that ADC value significantly decreases as the Gleason score increases, thereby DWI may help differentiate between low risk and high risk prostate cancer.
Mazaheri et al5 in year 2009 did a retrospective study to determine the accuracy of diffusion weighted magnetic resonance imaging for identifying cancer in the prostate peripheral zone and to assess the accuracy of tumor volume measurements made with T2-weighted imaging and combined T2-weighted and DW MR imaging by using surgical pathologic examination as the reference standard. Forty-two patients underwent endorectal MR at 1.5 T before undergoing radical prostatectomy. Associations between volume measurements from imaging and from pathologic examination were assessed by using concordance correlation coefficients (CCCs). In identifying malignant voxels, respective ADC cutoff values of 0.0014 and 0.0016 mm2/sec yielded sensitivity of 82% and 95% and specificity of 85% and 65%, respectively. The CCCs of combined T2-weighted and DWMR imaging (ADC cutoff, 0.0016 mm2/sec) was significantly higher than that of T2-weighted imaging alone. They concluded Adding DW MR to T2-weighted imaging can significantly improve the accuracy of prostate PZ tumor volume measurement.
Aytekin Oto et al6 in 2010 performed a study to analyze the diffusion Weighted scan in central gland (CG) prostate cancer, stromal hyperplasia (SH), and glandular hyperplasia (GH) and to determine the role of these parameters in the differentiation of CG cancer from benign CG. The average ADCs were 1.0x10-3, 1.27x10-3, and 1.7x 10-3, respectively, in CG carcinoma, Stromal Hyperplasia and Glandular Hyperplasia and differed significantly.
Baris Turkbey et al7 in the year 2010 performed a study To investigate whether apparent diffusion coefficients (ADCs) derived from diffusion-weighted (DW) magnetic resonance (MR) imaging at 3 T correlate with the clinical risk of prostate cancer in patients with tumors that are visible on MR images, with MR imaging/transrectal ultrasonography (US) fusion–guided biopsy as a reference. Forty-eight consecutive patients who underwent DW imaging during 3-T MR imaging with an endorectal coil were included in this retrospective study. Mean ADCs of cancerous target tumors were correlated with Gleason and D’Amico clinical risk scores. ADC was found to distinguish tumors in the peripheral zone with intermediate to high clinical risk from those with low clinical risk with a correct classification rate of 0.73.