Multiparametric Magnetic Resonance Imaging Versus Fine Needle Aspiration Cytology for Parotid Gland Neoplasms
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|ClinicalTrials.gov Identifier: NCT03849482|
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Parotid gland tumors are mostly treated surgically, but the extent of parotidectomy is decided upon preoperative work-up information. Preoperative management generally includes clinical evaluation, collection of a pathological sample, most often through fine-needle aspiration cytology (FNAC), and imaging. FNAC, despite its high sensitivity and specificity, has the drawback of an approximately 20 per cent rate of nondiagnostic or indeterminate result. Magnetic Resonance Imaging (MRI) provides the best morphological description of the lesion, which is helpful to the surgeon for the planning of the intervention. Recently, advanced functional techniques have been introduced, in association to the conventional morphologic ones: diffusion-weighted imaging (DWI) and dynamic contrast-enhanced imaging (DCEI) demonstrated the ability to provide information about the possible histological origin of parotid lesions. Multiparametric MRI (mp-MRI) comes from the combination of anatomical and functional sequences.
The Authors postulate that mp-MRI evaluation may be able to provide information not only about the extension of the lesion, but also about histology, with a high accuracy, at least comparable to ultrasound-guided FNAC.
In the present study, the Authors aim to define the value of FNAC and mp-MRI in the preoperative management of parotid gland tumors, comparing their success intended as the capability of the exam to be both diagnostic and accurate in formulating the correct histological suspect of malignancy.
Participants are patients affected by parotid gland neoplasms, candidates for surgical resection. The lesion will preoperatively be assessed with both clinical evaluation, ultrasound-guided FNAC and mp-MRI in our Institution. Mp-MRI includes conventional sequences, DWI and DCEI; its interpretation will allow the definition of the suspect histology. FNAC and mp-MRI suspects will be compared to the final histopathological report after surgical removal of the neoplasm.
The study considers a total of 100 patients, of whom 50 are analyzed retrospectively (being already operated after obtaining both FNAC and mp-MRI preoperatively) and the remaining 50 to be enrolled prospectively.
|Condition or disease||Intervention/treatment|
|Parotid Neoplasm Parotid Cancer||Diagnostic Test: Multiparametric Magnetic Resonance Imaging Diagnostic Test: Fine Needle Aspiration Cytology Diagnostic Test: Clinical Evaluation Diagnostic Test: Final Histopathological Diagnosis|
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|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Accuracy of Multiparametric Magnetic Resonance Imaging Versus Fine Needle Aspiration Cytology in the Preoperative Work-Up of Parotid Gland Neoplasms|
|Actual Study Start Date :||January 24, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Parotid Gland Neoplasms
Preoperative Assessment of Parotid Gland Neoplasms with:
Postoperative Collection of Final Histopathological Diagnosis
Diagnostic Test: Multiparametric Magnetic Resonance Imaging
Multiparametric MRI evaluation includes Conventional MRI, Diffusion-Weighted MRI and Dynamic Contrast-Enhanced MRI
Diagnostic Test: Fine Needle Aspiration Cytology
Ultrasound-Guided Fine Needle Aspiration Cytology
Diagnostic Test: Clinical Evaluation
Patient's history and physical examination, reporting signs and symptoms suggestive of malignancy (pain, facial nerve weakness, fixation to skin and surrounding tissues, trismus, skin ulceration, lymphadenopathy, numbness, weight loss)
Diagnostic Test: Final Histopathological Diagnosis
Final Diagnosis of the Disease from the Pathology Report after Surgical Resection of the Lesion
- Success of the diagnostic test (Multiparametric MRI and Fine Needle Aspiration Cytology) in the preoperative diagnosis of parotid gland tumors [ Time Frame: Baseline (preoperative) ]Success is intended as the capability of the diagnostic test (Multiparametric MRI and Fine Needle Aspiration Cytology) to be diagnostic (i.e. to make a diagnosis of benignity or malignancy) AND to correctly identify malignant tumors, compared to the final histopathological report
- Accuracy of the diagnostic test (clinical evaluation, fine needle aspiration cytology, conventional MRI, multiparametric MRI) in the preoperative diagnosis of parotid gland tumors [ Time Frame: Baseline (preoperative) ]Diagnostic accuracy of the test (clinical evaluation, fine needle aspiration cytology, conventional MRI, multiparametric MRI) is defined as the number of malignant lesions with "malignant" results in addition to benign lesions with "benign" results as a percentage of the total number of lesions
- Accuracy of the diagnostic test (Multiparametric MRI and Fine Needle Aspiration Cytology) in the preoperative diagnosis of the histopathology of parotid gland tumors [ Time Frame: Baseline (preoperative) ]Diagnostic accuracy of the test (Multiparametric MRI and Fine Needle Aspiration Cytology) is intended as the capability to preoperatively identify the histopathology of the tumor (pleomorphic adenoma, warthin tumor, carcinoma, lymphoma)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849482
|Contact: Davide Di Santo, MDfirstname.lastname@example.org|
|IRCCS San Raffaele||Recruiting|
|Milan, Italy, 20132|
|Contact: Davide Di Santo, MD +300226432172 email@example.com|