NCT05152056

Brief Summary

What value is given to MRI diffusion and perfusion sequences in the diagnosis of parotid tumors? Is a fine needle aspiration associated with MRI systematically necessary? The aim of the research is to study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2021

Completed
Last Updated

December 10, 2021

Status Verified

November 1, 2021

Enrollment Period

24 days

First QC Date

November 26, 2021

Last Update Submit

December 9, 2021

Conditions

Keywords

Parotid TumorDiffusion MRIPerfusion MRIAspiration cytologyFine-needle biopsy

Outcome Measures

Primary Outcomes (1)

  • Study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases

    Files analysed retrospectively from January 1, 2009 to June 30, 2020 will be examined]

Eligibility Criteria

Age6 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Minor and major subjects operated for a parotid tumor at Strasbourg University Hospital between January 2009 and June 2020 and having had in the preoperative assessment an MRI of the parotid, also carried out at the Strasbourg University Hospital.

You may qualify if:

  • Major subject (≥18 years old)
  • Minor subject (\<18 years old)
  • Operated for a parotid tumor at Strasbourg University Hospital between January 2009 and June 2020
  • Having had in the preoperative assessment an MRI of the parotid, also carried out at the Strasbourg University Hospital.
  • Subject (and / or his parental authority) not having expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.

You may not qualify if:

  • Subject (or his parents) who expressed his (their) opposition to participating in the study
  • Lack of pathological or MRi results
  • Subject under guardianship, curatorship or safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'ORL et de Chirurgie Cervico-Faciale - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Parotid Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland NeoplasmsMouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesParotid DiseasesSalivary Gland Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2021

First Posted

December 9, 2021

Study Start

November 15, 2021

Primary Completion

December 9, 2021

Study Completion

December 9, 2021

Last Updated

December 10, 2021

Record last verified: 2021-11

Locations