Multiparametric Magnetic Resonance Imaging Versus Fine Needle Aspiration Cytology for Parotid Gland Neoplasms

NCT03849482 | Unknown

• 1 other identifier: MultiParotid
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parotid Neoplasm; Parotid Cancer

Keywords

Fine Needle Aspiration Cytology; Multiparametric Magnetic Resonance Imaging; Diffusion-Weighted Magnetic Resonance Imaging; Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Success of the diagnostic test (Multiparametric MRI and Fine Needle Aspiration Cytology) in the preoperative diagnosis of parotid gland tumors

  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

  Baseline (preoperative)

Secondary Outcomes (2)

• Accuracy of the diagnostic test (clinical evaluation, fine needle aspiration cytology, conventional MRI, multiparametric MRI) in the preoperative diagnosis of parotid gland tumors

  Baseline (preoperative)

• Accuracy of the diagnostic test (Multiparametric MRI and Fine Needle Aspiration Cytology) in the preoperative diagnosis of the histopathology of parotid gland tumors

  Baseline (preoperative)

Study Arms (1)

Parotid Gland Neoplasms

Preoperative Assessment of Parotid Gland Neoplasms with: * Clinical Evaluation; * Fine Needle Aspiration Cytology; * Multiparametric Magnetic Resonance Imaging. Postoperative Collection of Final Histopathological Diagnosis

Diagnostic Test: Multiparametric Magnetic Resonance Imaging; Diagnostic Test: Fine Needle Aspiration Cytology; Diagnostic Test: Clinical Evaluation; Diagnostic Test: Final Histopathological Diagnosis

Interventions

Multiparametric Magnetic Resonance Imaging DIAGNOSTIC_TEST

Multiparametric MRI evaluation includes Conventional MRI, Diffusion-Weighted MRI and Dynamic Contrast-Enhanced MRI

Parotid Gland Neoplasms

Fine Needle Aspiration Cytology DIAGNOSTIC_TEST

Ultrasound-Guided Fine Needle Aspiration Cytology

Parotid Gland Neoplasms

Clinical Evaluation DIAGNOSTIC_TEST

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)

Parotid Gland Neoplasms

Final Histopathological Diagnosis DIAGNOSTIC_TEST

Final Diagnosis of the Disease from the Pathology Report after Surgical Resection of the Lesion

Parotid Gland Neoplasms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are affected by parotid gland neoplasms candidate for surgical removal. The lesion will be preoperatively assessed by both clinical evaluation, ultrasound-guided fine needle aspiration citology and multiparametric MRI. Participants will undergo surgery and the pathology report will be collected.

You may qualify if:

• Parotid gland tumor, candidate for surgical removal

You may not qualify if:

• Non-neoplastic lesions (inflammatory, infectious)
• Lesions smaller than 1 cm (multiparametric MRI analysis not feasible)
• Patients who refuse surgical procedure
• Patients who refuse to take part to the present study

Sponsors & Collaborators

• Davide Di Santo: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (4)

• Yabuuchi H, Fukuya T, Tajima T, Hachitanda Y, Tomita K, Koga M. Salivary gland tumors: diagnostic value of gadolinium-enhanced dynamic MR imaging with histopathologic correlation. Radiology. 2003 Feb;226(2):345-54. doi: 10.1148/radiol.2262011486.

  PMID: 12563124 BACKGROUND

• Yabuuchi H, Matsuo Y, Kamitani T, Setoguchi T, Okafuji T, Soeda H, Sakai S, Hatakenaka M, Nakashima T, Oda Y, Honda H. Parotid gland tumors: can addition of diffusion-weighted MR imaging to dynamic contrast-enhanced MR imaging improve diagnostic accuracy in characterization? Radiology. 2008 Dec;249(3):909-16. doi: 10.1148/radiol.2493072045. Epub 2008 Oct 21.

  PMID: 18941162 BACKGROUND

• Liu CC, Jethwa AR, Khariwala SS, Johnson J, Shin JJ. Sensitivity, Specificity, and Posttest Probability of Parotid Fine-Needle Aspiration: A Systematic Review and Meta-analysis. Otolaryngol Head Neck Surg. 2016 Jan;154(1):9-23. doi: 10.1177/0194599815607841. Epub 2015 Oct 1.

  PMID: 26428476 BACKGROUND

• Liang YY, Xu F, Guo Y, Wang J. Diagnostic accuracy of magnetic resonance imaging techniques for parotid tumors, a systematic review and meta-analysis. Clin Imaging. 2018 Nov-Dec;52:36-43. doi: 10.1016/j.clinimag.2018.05.026. Epub 2018 Jun 7.

  PMID: 29908348 BACKGROUND

MeSH Terms

Conditions

Parotid Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging; Physical Examination

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Davide Di Santo, MD

CONTACT

+390226432172; disanto.davide@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 21, 2019
• Study Start: January 24, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)