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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA ANNEXURE-II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. NAME OF THE CANDIDATE AND ADDRESS (IN BLOCK LETTERS) DR. ANINDYA SUNDAR DAS POST GRADUATE STUDENT, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, BANGALORE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL. 5/3, HOSUR ROAD, BANGALORE-560 029. 2. NAME OF THE INSTITUTION BANGALORE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL AND POST GRADUATE RESEARCH CENTRE, BANGALORE - 560 029. 3. COURSE OF THE STUDY AND SUBJECT MASTER OF DENTAL SURGERY(MDS), ORAL MEDICINE AND RADIOLOGY 4. DATE OF ADMISSION TO COURSE JUNE 2012 5. TITLE OF THE TOPIC “Ultrasound Elastography Evaluation of Salivary Glands – in Patients Undergoing Radiotherapy of Head And Neck Malignancy.” 6. BRIEF RESUME OF INTENDED WORK: 6.1 NEED FOR STUDY Radiotherapy is one of the major treatment modality in head & neck malignancies The most important complication of head and neck radiotherapy is the changes in the salivary glands in the field of radiation therapy. These effects lead to parenchymal and vascular changes within the gland which in turn alters the volume and viscosity of the salivary secretion through the affected gland. There are several changes happen in tissues located within the radiation field after radiotherapy which can be evaluated by clinically sialometry, sialochemistry and various imaging modalities, like CT scan, MRI and Ultrasonography. Sialometry and sialochemistry, they can give only functional status, but does not give the morphological characteristics of salivary gland, such as size, shape, elasticity, blood flow and nature of the parenchymal tissue changes which can be obtained by Ultrasonography. Earlier, conventional Elastography was the technique employed to study the physical properties of soft tissue details. However this technique is operator dependant & evaluates the soft tissue with less reproducibility and with relative qualitative assessment, whereas now ARFI Elastography is a modern advancement, which is non invasive and uses accurate method to assess quantitative estimation of elastic changes in the soft tissues using acoustic force impulses or push pulse technique. Review of literature on the ultrasound evaluation of salivary glands during radiotherapy has shown very limited studies and no study so far done using ARFI elastography. Hence a study was designed to assess the morphological changes of salivary glands during radiation therapy using ARFI elastography. 6.2 REVIEW OF LITERATURE: 1. This study1 was conducted on 20 patients who were undergoing radiotherapy in head & neck malignancy . The parotid & submandibular glands were present under that radiation field. Glands were evaluated before and during radiotherapy. A significant differences in length , height , depth and also echotexture, echogenicity and gland margins were observed before and after radiotherapy. 2. In this study2 Doppler ultrasound was used to assess the haemodynamic condition of the salivary glands.The amount of radiation dosage was co-relate with the ultrasound radiographic changes of the 18nasopharyngeal carcinoma patients. The results showed that the post-RT salivary glands were significantly smaller to the pre-RT ones and also demonstrated lower vascular velocity, resistive & pulsatility. 3. The aim of this study3 was to establish the elasticity values of various normal tissues like thyroid, liver, spleen, parotid & submandibular salivary glands etc by using shearwave ultrasound elastography which was a relatively new technique employed..The results showed that the normal elasticity values of various tissues obtained in kilopascals was found to be very useful to determine the normal & pathological tissues. 4. The aim of this study4 was to measure changes in the salivary flow rate in head & neck cancer following accelerated radiotherapy & concurrent chemotherapy in the disease free period of one year following treatment. The results showed a significant reduction in flow rate which decreased further till the six months and a recovery following 12 months of the study. 5. In this study5 the new advancement of ultrasound technique acoustic radiation force impulse (ARFI) imaging or elastography technique was used to evaluate an improved visualization of parotid tumours. Result of this study showed that elastography imaging can be differentiate into various pathological masses of parotid gland, and also can be differentiate between normal and pathologic condition of the glands. 6.3 OBJECTIVE OF THE STUDY 7. To study the ARFI Elastography changes of salivary glands in head & neck malignancy patients undergoing radiotherapy. To co-relate the morphological changes of the salivary glands with the salivary flow rate. MATERIALS AND METHODS 7.1 Source of data Patients of head and neck cancers visiting the Department of Radiotherapy at the Bangalore Institute of Oncology, Bangalore. Inclusion criteria: 1) Patients having normal morphological parotid and submandibular glands in the field of radiotherapy for any head and neck cancers. 2) Patients receiving bilateral radiotherapy with salivary glands in the radiation filed with the radiation dose of 50grays. 3) All patients undergoing external beam therapy. Exclusion criteria: 1) Patients with the presence of salivary glands diseases such as Sjogren’s disease, salivary gland masses ,viral and bacterial diseases etc. 2) Patients with history of previous radiotherapy or surgical procedure in the gland region. 3) Systemic diseases like diabetes, hypertension, renal diseases etc 4) Patients who are on medications. MATERIALS USED: Elastography Machine:1. Siemen Acuson S 2000 2. Linear probe of frequency 9-14 MHz 3. Linear matrix probe of frequency 4-9 MHz Graduated test tube to measure whole saliva. Stimulant for saliva secretion. Funnel to collect the saliva. 7.2 METHODS OF COLLECTION OF PROCEDURES, IF ANY DATA (INCLUDING SAMPLING A total of 20 patients(20x4glands=80glands)will be selected randomly for the study, during the period of 2012-2015.from the department of radiotherapy fulfilling all the inclusion and exclusion criteria. Patients with head and neck cancers receiving radiotherapy in the field of salivary glands, will be assessed for the evaluation of salivary gland changes using Ultrasound Elastography Detailed case history of the patient regarding the type of cancer, total dosage/fraction clinical and salivary gland examination will be done & recorded in a proforma. Ultrasonographic evaluation prior to radiotherapy will be done to evaluate the morphology of salivary gland in the field of radiotherapy. The same patients will be further evaluated during 2nd and 6th week of radiotherapy to assess the morphological changes in the gland. To co-relate the ultrasonographic changes with salivary flow rate changes, salivary flowmetry will be done simultaneously during each ultrasonographic assessment. All patients unstimulated & stimulated saliva will be taken in a standardized time in a day between 10am and 12 noon, at least 1hour after breakfast. Unstimulated saliva collection The patient will be made to seat and bent slightly forward. The patient will be asked to split into the saliva collecting funnel which will be connected into the graduated test tube. Stimulated saliva collection:- First the patient is asked to clear the mouth by swallowing the residual saliva and then instruction will be given to chew the piece of paraffin wax for 30seconds to stimulate the salivary flow. After 30 seconds the patient is asked to expectorate in to the spitton , further continuation of chewing for a 5minutes will be done and the stimulated saliva will be collected at regular intervals in that graduated test tube. The findings of the morphological changes of the salivary glands from ARFI Ultrasonography will be compared with the salivary flow changes using statistical analysis.There are two types of variants which will be used in this study they are Scores(paired ‘t’test) & Categorical(Mc Nemar’s test)tests. 7.3 Does the study require any investigations or interventions to be conducted on patients or both humans or animals? If so, please describe briefly. Yes 7.4 Has ethical clearance been obtained from your institute in case of 7.3? Yes 8. LIST OF REFERENCES: 1. M Imanimoghaddam, M Rahrooh, Z Tafakhori, S Zahedanaraki and F Homaeieshandiz. “Changes of parotid and submandibular glands caused by radiotherapy – An Ultrasound Evaluation”, Dentomaxillofacial Radiology.2012;41:379–384. 2. V W C WU, PhD, M T C YING, PhD and D L W KWONG, “Evaluation of radiation-induced changes to parotid glands,” The British Journal of Radiology. 2011; 84:843-849. 3. Kemal Arda,Nazan Ciledag,Elif Aktas,Bilgin Kadri Arıbas,Kenan Köse, “Quantitative Assessment of Normal Soft-Tissue Elasticity,” . AJR .2011; 197. 4. Punita lal,Ranjeet Bajpai,Rohini khurana,K.J.Maria das,Prabhat kumar,Anu Tiwari,Neha Gupta,Shaleen kumar, “Changes in salivary flow rates in head and neck cancer after chemoradiotherapy,” Journal of Cancer Research and Therapeutics. 2010; 6(4). 5. Andreas Knopfa, Naglaa Mansoura, Konrad Stockb, “Application of contrast – enhanced ultrasound and acoustic radiation force impulse imaging in parotid gland lesion,” European Journal of Radiology, 2011; 78(Extra): e115–e118. 9. SIGNATURE OF CANDIDATE 10. REMARKS OF THE GUIDE 11. NAME AND DESIGNATION OF (IN BLOCK LETTERS) 11.1 GUIDE DR. JAYANTHI.K PROFESSOR & H.O.D. DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY BANGALORE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE – 560 029. 11.2 SIGNATURE 11.3 CO-GUIDE DR.SUDHAKAR H.O.D DEPARTMENT OF RADIOLOGY (ULTRASONOGRAPHY) BANGALORE INSTITUTE OF ONCOLOGY, BANGALORE-560 027 11.4 SIGNATURE 11.5 HEAD OF THE DEPARTMENT 11.6 SIGNATURE DR. JAYANTHI.K PROFESSOR & H.O.D. DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY BANGALORE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE – 560 029. 12. 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPLE 12.2 SIGNATURE DR.VINAYA S. PAI PRINCIPAL, BANGALORE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE – 560 029.