Clinical trial NCT05962944: Remote Rapid Onsite Evaluation (ROSE) for Head and Neck Fine Needle Aspirations (FNA)
Official title: Remote Rapid On-site Evaluation (ROSE) for Head and Neck Fine Needle Aspirations (FNA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Neoplasms
Lead sponsor: Royal Cornwall Hospitals Trust
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 19
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rapid on site evaluation can be provided using telecytology
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
Study officials:
affiliation: Royal Cornwall Hospital
name: Leonie Wheeldon
role: PRINCIPAL_INVESTIGATOR
References: