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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
Sponsor:
Information provided by (Responsible Party):
Davide Di Santo, IRCCS San Raffaele

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.


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

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Parotid gland tumor, candidate for surgical removal

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849482


Contacts
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Contact: Davide Di Santo, MD +390226432172 disanto.davide@hsr.it

Locations
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Italy
IRCCS San Raffaele Recruiting
Milan, Italy, 20132
Contact: Davide Di Santo, MD    +300226432172    disanto.davide@hsr.it   
Sponsors and Collaborators
Davide Di Santo

Additional Information:

Publications:
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Responsible Party: Davide Di Santo, Principal Investigator, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03849482     History of Changes
Other Study ID Numbers: MultiParotid
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No consent from the participants to share data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Davide Di Santo, IRCCS San Raffaele:
Fine Needle Aspiration Cytology
Multiparametric Magnetic Resonance Imaging
Diffusion-Weighted Magnetic Resonance Imaging
Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Additional relevant MeSH terms:
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Neoplasms
Parotid Neoplasms
Salivary Gland Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Parotid Diseases
Salivary Gland Diseases