RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
PROFORMA FOR REGISTRATION OF SUBJECT FOR RESEARCH PROJECT
1. / NAME OF THE INVESTIGATOR AND ADDRESS(In Block Letters) / DR. PATEL ANKIT MANSUKHLAL
POST GRADUATE
DEPARTMENT OF ORAL & MAXILLOFACIAL SURGERY,
COLLEGE OF DENTAL SCIENCES,
DAVANGERE - 577004
KARNATAKA.
2. / NAME OF THE
INSTITUTION / COLLEGE OF DENTAL SCIENCES,
DAVANGERE-577004
3. / COURSE OF STUDY AND SUBJECT / MASTER OF DENTAL SURGERY (M.D.S)
ORAL & MAXILLOFACIAL SURGERY
4. / DATE OF ADMISSION TO COURSE / 23rd JULY, 2013
5. / TITLE OF THE DISSERTATION: / “HARD TISSUE INVASION IN ORAL MALIGNANCIES: COMPARISON BETWEEN RADIOGRAPHIC ASSESSMENTS WITH HISTOPATHOLOGIC FINDINGS - A RETROPROSPECTIVE STUDY.”
6. / BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
Oral malignancies are one of the most prevalent malignancies in the world, leading to one of the 10 most common causes of death. Oral malignancies represent approximately 13% of all malignancies, thereby, translating into 30,000 new cases every year.2
One of the most important aspects of preoperative staging in head and neck surgery is the determination of malignancies’ local bone invasion, because the extent of the surgical procedure and the application of further therapy modalities are crucially influenced by this information. Different imaging modalities, such as panoramic radiographs, bone scans, CT scans and magnetic resonance imaging (MRI) scans have been used for this purpose, however, there is no single modality that has proven accurate enough. Hence, this study will be carried out with an objective to determine the accuracy of panoramic radiography and conventional CT/MRI in the detection of bone invasion in patients scheduled to undergo surgery for clinically diagnosed oral malignancies.
6.2 Review of Literature:
1. Dreiseidler and et al (2011) compared the performance of cone-beam computerized tomography (CBCT) with multislice CT (MSCT) and single photon emission CT (SPECT) in detection of bone invasion from oral malignancies. In the study, 77 patients with histological proven malignancy of the oral cavity received MSCT, CBCT and SPECT imaging of the head presurgically. Radiologic evaluations were compared with histopathologic examination of the resected tumor specimens. The results showed that CBCT was accurate in predicting malignancies’ bone involvement and can compete with MSCT and SPECT in detecting bone invasion in patients with oral malignancies.1
2. Kushraj and et al (2011) compared the accuracy and predictability of an Orthopantamograph (OPG), conventional Computed Tomography (CT), and Single Positron Emission Computed Tomography (SPECT) in the detection of bone invasion in squamous cell carcinoma patients. A descriptive study was carried out on 15 patients with clinically and histopathologically diagnosed squamous cell carcinoma. OPG, conventional CT, and SPECT were carried out on all patients. Subsequently, the bone adjacent to the tumor was assessed histopathologically and severed as a gold standard. The study showed that SPECT was highly sensitive, but with a very low specificity due to increase in false positive values. However, OPG and conventional CT showed an acceptable degree of sensitivity and specificity.2
3. Kalavrezos and et al (1996) tried to determine the correlation of imaging and clinical features in the assessment of mandibular invasion in oral carcinomas. They compared the accuracy of Bone Scintigraphy (BS) and computed tomography (CT) with clinical assessment and the histopathologic findings. The data showed positive preoperative bone scans in 40 out of 41 patients. In only 1 (2 %) patient was the result of bone scanning false-negative; i.e. the mandibular destruction was not detected. CT data was obtained in 47 patients. The imaging findings corresponded well with the histopathologic results in 37 (62 %) patients. There were 7 (22 %) patients in whom CT did not reveal bony erosion while the histology proved to be positive.3
4. Rao and et al (2004) tried to evaluate the relative merits and accuracy of clinical examination and orthopantomograms (OPGs) in determining the incidence and extent of bone invasion in carcinomas of the mandibular region. They carried out a prospective study on 51 (21 female and 30 male; mean age of 53.4 years) patients undergoing mandibular resections for oral squamous cell carcinoma. They concluded that clinical examination and OPGs were found sensitive enough to be used as primary investigative modalities, and when considered together, the clinical and radiological examination were able to detect all the cases of bone invasion but both tend to over-predict the extent of invasion, resulting in unnecessary loss of mandible.4
5. Rajesh and et al (2007) tried to determine whether MRI can replace SPECT and CT in detecting bone invasion in patients with oral squamous cell carcinoma. They conducted a retrospective and independent review of the MRI, SPECT, and when available CT, images of 23 patients with oral malignancy who had formal bone resection was undertaken. Histopathology was their gold standards. Bone involvement was seen in 19 out of 23 resections. According to them, the sensitivity of MRI was 100% and specificity was 75 %, with no false positive or false negative result. The sensitivity of SPECT was also 100% with specificity of 50 %. There were 2 false positives and no false negatives on SPECT scan. Hence, they concluded that the addition of SPECT and CT to routine MRI staging protocols may no longer be indicated. CT may be useful in some selected cases to assess maxillary involvement because of the thinner cortex of the maxilla.5
6. Lane et al (2000) tried to determine the use of computed tomography in the assessment of mandibular invasion in carcinoma of the retromolar trigone. In the study, they reviewed the records of patients with biopsy-proven RMT carcinomas treated between 1984 and 1998 with attention to preoperative CT scans and histopathologic findings during surgery. Half of the patients who were treated with primary resection had mandibular invasion. Bone invasion was not identified radiographically in 27 % of patients with preoperative CT scans. They concluded that CT is a useful, but potentially inaccurate, predictor of bone invasion in RMT.6
6.3 Objectives Of the Study:
· The purpose of the study is to evaluate the diagnostic efficacy of panoramic radiography and conventional CT/ MRI in assessing hard tissue invasion in oral malignancies.
7. / MATERIALS AND METHODS:
7.1 Source of Data:
The proposed study will include patients reporting to the out-patient section of the Dept. of Oral and Maxillofacial Surgery, College of Dental Sciences & Hospital, Davangere and also records of patients with oral malignancies, treated surgically in our Department will be reviewed. Patients with a histologically-proven oral malignancy (as confirmed by incision biopsy) will be included in the study. Each patient will be given a brief description of the intended procedure and will be required to sign an inform-consent sheet. The interim period between radiographic evaluation and surgery will be less than 8 weeks in each case.
Inclusion criteria:
· Patients in the age range of 15-70yrs.
· Malignancies of the oral cavity.
· General medical condition of the patient permitting for procedure.
Exclusion criteria :
· Pregnant patients.
· Severely medically-compromised patients.
· History of osteomyelitis and osteoradionecrosis.
· Patients with claustrophobia.
· Patient not willing for surgery or who refuse to sign the inform-consent sheet.
Study Design :
· This is a retro-prospective, clinical study.
· Sample size: 30
7.2 Methods of collection of Data:
1. Patients
Thirty Patients with histologically diagnosed for oral malignancies will be examined by panoramic radiography and conventional CT/MRI.
2. Assessment of images
Panoramic radiographs will be assessed for evidence of bone invasion. In CT/MRI, bone invasion will be considered positive when the partial or complete erosion of the cortical bone will be visible.
3. Surgery
All patients will undergo surgical treatment, including marginal or segmental bone resection in the primary tumor area within 8 weeks of imaging.
4. Pathologic assessment
The presence of bone invasion by tumor will be determined by histopathological findings.
· All the collected data parameters will be analyzed statistically.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
· Radiological investigations
1. Panoramic radiography
2. Conventional Computed tomography/Magnetic Resonance Imaging (MRI)
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes (Ref. No: CODS/IRB/15/2013-14)
8. / LIST OF REFERENCES:
1. Dreiseidler T, Alarabi N, Ritter L: A comparison of multislice computerized tomography, cone-beam computerized tomography, and single photon emission computerized tomography for the assessment of bone invasion by oral malignancies. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2011 Sep;112(3):367-74
2. Kushraj T, Chatra L, Shenai P: Bone invasion in oral cancer patients: A comparison between Orthopantamograph, conventional computed tomography, and single positron emission computed tomography: J Cancer Res Ther 2011 Oct-Dec; 7(4): 438-41.
3. Kalavrezos ND, Gratz KW, Sailer HF: Correlation of imaging and clinical features in the assessment of mandibular invasion of oral carcinomas. Int. J. Oral Maxillofac. Surg. 1996 Dec; 25(6):439-45.
4. Rao LP, Das SR, Mathews A: Mandibular invasion in oral squamous cell carcinoma: investigation by clinical examination and orthopantomogram. Int J Oral Maxillofac Surg. 2004 Jul; 33(5):454-7.
5. Rajesh A, Khan A, Kendall C: Can magnetic resonance imaging replace single photon computed tomography and computed tomography in detecting bony invasion in patients with oral squamous cell carcinoma? Br J of Oral Maxillofac Surg 2008 Jan;46(1):11-4
6. Lane AP, Buckmire RA, Mukherji SK: Use of computed tomography in the assessment of mandibular invasion in carcinoma of the retromolar trigone: Otolaryngol Head Neck Surg 2000 May; 122(5):673-7.
9. / SIGNATURE OF THE INVESTIGATOR
10. / REMARK OF THE GUIDE
11. / NAME AND DESIGNATION
(In Block Letters)
11.1 GUIDE
11.2 SIGNATURE / DR. SIVA BHARANI K. S. N.,
PROFESSOR AND HEAD
DEPARTMENT OF ORAL & MAXILLOFACIAL SURGERY,
COLLEGE OF DENTAL SCIENCES, DAVANGERE-577004
KARNATAKA.
11.3 CO-GUIDE (if any)
11.4 SIGNATURE
11.5 HEAD OF THE
DEPARTMENT
11.6 SIGNATURE / DR. SIVA BHARANI K. S. N.,
PROFESSOR AND HEAD
DEPARTMENT OF ORAL & MAXILLOFACIAL SURGERY,
COLLEGE OF DENTAL SCIENCES, DAVANGERE-577004
KARNATAKA.
12. / 12.1 REMARKS OF THE
CHAIRMAN AND
PRINCIPAL
12.2 SIGNATURE