Remote Rapid Onsite Evaluation (ROSE) for Head and Neck Fine Needle Aspirations (FNA) (Remote ROSE)

Remote Rapid On-site Evaluation (ROSE) for Head and Neck Fine Needle Aspirations (FNA)

Rapid On-Site Evaluation (ROSE) of cytology FNA samples performed by a Pathologist or Biomedical Scientist is a real time morphological assessment of the sample in the clinical setting with the aim of acquiring all the diagnostic material in one appointment resulting in reduction in costs, improved patient care and reduced referral to treatment time.

It is not practical or possible for the ROSE team to be present in every location where an FNA is performed. Telecytology (TC) or remote ROSE is a digital form of ROSE which allows a biomedical scientist or pathologist working in a remote laboratory to review the cytology slides in real time, using microscope images fed from the location where the FNA procedure is being performed.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Device: Olympus Cellsens software

Detailed Description

The new faster diagnostic standards (FDS) alongside NICE guidance and the British association of Head and Neck Oncologists (BAHNO) guidelines, state that ROSE should be provided for all FNA's. It is not practical or possible for the ROSE team to be present in every location where an FNA is performed. Telecytology (TC) or remote ROSE is a digital form of ROSE which allows a biomedical scientist or pathologist working in a remote laboratory to review the cytology slides in real time, using microscope images fed from the location where the FNA procedure is being performed.

A trained a clinical imaging assistant (CIA) will prepare the slides and drive the microscope in the ultrasound room. Using the Olympus software Cellsens and the screen share option in Microsoft teams, the remote biomedical scientist / pathologist will be able to assess the sample in real time and provide both verbal and written methods of communication (relevant clinical information and instructions). An additional camera will allow visualisation of the slide preparation and residual material in real time to the scientist / pathologist performing the assessment.

This study will investigate whether ROSE can be performed remotely. This study will be based in the cytology department at the Royal Cornwall Hospital as part of a service improvement. Phase 2 will involve the use of the Tower Block ultrasound room located on the Royal Cornwall Hospitals Truro site and in phase 3 the ultrasound room at The Royal Cornwall Hospital's Camborne and Redruth site.

Patients between the ages of 18 and 90 years attending for an ultrasound guided fine needle aspiration of lesions in the head and neck and supraclavicular fossa nodes will be consented for remote ROSE to be performed over a 12-month period.

• Study Type: Observational
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • Royal Cornwall Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants attending for an ultrasound guided fine needle aspiration of lesions in the head and neck and supraclavicular fossa nodes.

Description

Inclusion Criteria:

• Male and female participants > 18-90 years of age
• Participants attending for an ultrasound guided fine needle aspiration of lesions in the head and neck and supraclavicular fossa nodes.
• All ethnicity or socioeconomic grouping that require an US FNA at RCHT over the 12-month study period.
• Able and willing to consent to the study

Exclusion Criteria:

• Anyone <18 years of age
• Patients that do not require an FNA after the initial ultrasound
• Any participants considered vulnerable will not be included in the study.
• This study involves testing the concept of remote ROSE rather than direct impact on patient care needs related to ethical of communication issues. For practical considerations and to prevent unnecessary anxiety for patients who are unable to read the information sheets and provide consent, these patients will not be included in the study.
• Unable or unwilling to consent to the study

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laboratory testing; Slides reviewed in the laboratory to test the platform for suitability prior to involving patients	Device: Olympus Cellsens software; Olympus cellsens software will be used to visualise the cells and MS teams screen share will be used to send the live images in real time.; Other Names: Microsoft teams
Remote ROSE on the same site as the laboratory; The next phase will involve remote ROSE being performed on the same site as the laboratory in an ultrasound room located on the Royal Cornwall Hospitals Truro site.	Device: Olympus Cellsens software; Olympus cellsens software will be used to visualise the cells and MS teams screen share will be used to send the live images in real time.; Other Names: Microsoft teams
Remote ROSE at a site external to the laboratory; Phase 3 will involved remote ROSE being performed on a different site to the laboratory. The ultrasound room at The Royal Cornwall Hospital's Camborne and Redruth site.	Device: Olympus Cellsens software; Olympus cellsens software will be used to visualise the cells and MS teams screen share will be used to send the live images in real time.; Other Names: Microsoft teams

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rapid on site evaluation can be provided using telecytology	To robustly test the concept of remote rapid on site evaluation for head and neck. The Scientist performing the remote ROSE will record the assessment findings: Inadequate sampling - Advise repeat sampling; Adequate sampling - Stop procedure.; Diagnostic sampling but more material required. - Advise repeat sampling; Diagnostic sampling and sufficient cell yield - Stop procedure These findings will be compared with the final diagnostic outcomes (Final report) issued by the laboratory. The overall effectiveness of remote ROSE will be compared against current practice for head and neck FNA in terms of adequacy and diagnostic yield. If over 80% of samples obtained with remote ROSE are deemed adequate and sufficient then the trial will be regarded as successful. This prevents the majority of patients having to return for additional appointments and procedures.	12 months

Collaborators and Investigators

• Sponsor: Royal Cornwall Hospitals Trust
• Investigators: Principal Investigator: Leonie Wheeldon, Royal Cornwall Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): July 24, 2023

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: RoyalCornwallHT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No