Clinical trial · Observational
Multiparametric Magnetic Resonance Imaging Versus Fine Needle Aspiration Cytology for Parotid Gland Neoplasms
Accuracy of Multiparametric Magnetic Resonance Imaging Versus Fine Needle Aspiration Cytology in the Preoperative Work-Up of Parotid Gland Neoplasms
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Parotid Cancer | — | UNRESOLVED | — |
| Parotid Neoplasm | Parotid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical Evaluation | Diagnostic Test | — | UNRESOLVED |
| Final Histopathological Diagnosis | Diagnostic Test | — | UNRESOLVED |
| Fine Needle Aspiration Cytology | Diagnostic Test | — | UNRESOLVED |
| Multiparametric Magnetic Resonance Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Parotid Gland Neoplasms
- description
- Preoperative Assessment of Parotid Gland Neoplasms with: * Clinical Evaluation; * Fine Needle Aspiration Cytology; * Multiparametric Magnetic Resonance Imaging. Postoperative Collection of Final Histopathological Diagnosis
- interventionNames
- Diagnostic Test: Multiparametric Magnetic Resonance Imaging
- Diagnostic Test: Fine Needle Aspiration Cytology
- Diagnostic Test: Clinical Evaluation
- Diagnostic Test: Final Histopathological Diagnosis
Primary outcomes (1)
- measure
- Success of the diagnostic test (Multiparametric MRI and Fine Needle Aspiration Cytology) in the preoperative diagnosis of parotid gland tumors
- timeFrame
- Baseline (preoperative)
- description
- 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 outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDYabuuchi 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
- BACKGROUNDYabuuchi 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
- BACKGROUNDLiu 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
- BACKGROUNDLiang 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