Basal Cell CarcinomaFCM-PNCT03610620
Confocal Microscopy Evaluation of Margin Clearance in Basal Cell Carcinomas in Mohs Surgery
A study testing Vivascope 2500 ex-vivo fluorescent confocal microscope in people with Basal Cell Carcinoma, run by Julie Dawson at 1 site in United Kingdom.
Trial summary
This study is comparing the accuracy and speed of the Vivascope 2500 ex-vivo fluorescent confocal microscope with frozen section Mohs histology in evaluating clear margins in basal cell carcinoma in Mohs surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Vivascope 2500 ex-vivo fluorescent confocal microscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2017to 9 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Patient with basal cell carcinoma on the head and neck undergoing Mohs surgery with frozen sections
- Patient willing and able to give informed consent
- Patient treated not previously or currently treated with a hedgehog inhibitor medication (vismodegib)
- Patient suitable for Mohs surgery
- Excised lesion suitable for scanning with FCM as determined by investigator -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
Official title: Does Ex-vivo Fluorescence Confocal Microscopy Allow Faster Evaluation of Margin Clearance in Basal Cell Carcinomas in Mohs Surgery: A Pilot Study
This study is comparing the accuracy and speed of the Vivascope 2500 ex-vivo fluorescent confocal microscope with frozen section Mohs histology in evaluating clear margins in basal cell carcinoma in Mohs surgery.
Read the detailed description
Patients with basal cell carcinomas in the head and neck area, being considered for Mohs surgery with frozen sections will be invited to participate in this trial by the investigators when they attend for their pre-surgical consultation. They will be given sufficient time to review the information sheet and ask questions. When they attend for their Mohs surgery, they will be recruited if they wish to participate in this trial, at which point, the investigator, or an authorized member of their team, will obtain written informed consent for patients. The patient will then undergo Mohs surgery. The processing and interpretation with frozen sections will be conducted in the same way, the only difference being immediately after the BCC is excised with a Mohs bevelled edge (45o incision), the tissue is immersed in acridine orange (nuclear DNA stain) and placed upside down with the deep margin of the tissue face up. With a glass slide placed on top, we would place the FCM (Vivascope 2500) over this, scan the tissue and obtain mosaic images of the tissue which would be stitched together. The penetration of the FCM scan is approximately 0.25mm. This is approximately the distance between 2-3 Mohs wafers. The investigators would usually consider a margin of 3 Mohs wafers (300 microns) clear. When the scanning is completed (5 minutes), the Mohs layer would be sent for frozen section (stained with haematoxylin and eosin) for confirmation in the usual way. The Mohs surgeon can interpret the FCM mosaic images later. Acridine orange does not interfere with frozen sections or paraffin histopathological quality. No medicines will be used in this study. The information is collected on only 1 patient visit. There is no follow up period. The main objectives would (1) compare the accuracy in detection of BCC margins with FCM compared with FSM and (2) evaluate the time taken for processing and interpretation of FCM (acridine orange inking and rinsing, image acquisition and mosaic stitching, and image interpretation) compared with the time taken for processing and interpretation of FSM (sample flattening, freezing and cutting with the cryostat, H\&E staining, slide cover slipping and slide interpretation).
- Conditions
- Basal Cell Carcinoma
- Being tested
- Vivascope 2500 ex-vivo fluorescent confocal microscope
- Keywords
- Basal cell carcinoma, Mohs surgery, Vivascope 2500 ex-vivo fluorescent confocal microscope, Frozen section Mohs histology
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivascope 2500 ex-vivo fluorescent confocal microscopeProcedure or surgery
scanned with the Vivascope 2500
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Experimental | Vivascope 2500 ex-vivo fluorescent confocal microscope Receives: Procedure: Vivascope 2500 ex-vivo fluorescent confocal microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the specificity and sensitivity of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
Compare the specificity and sensitivity of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
Measured: 1 DAY
Secondary outcomes (1)
To compare the time taken for processing and interpretation of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
Compare the time taken for processing and interpretation of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
Measured: 1 DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start12 Jun 2017
- Primary completion9 Aug 2018
- Study completion9 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Compare accuracy and speed of the Vivascope 2500 to frozen sections.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Dawson
- Sponsor type
- University, hospital or other
- Collaborators
- Mavig GmbH
- Responsible party
- Sponsor-investigator, Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust
- Investigators
- Eunice Tan, Consultant, Principal investigator, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610620
- Sponsor's protocol ID
- 212591
- Acronym
- FCM-P
- Status last verified
- Nov 2019
- First submitted
- 26 Jul 2018
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ex-vivo Fluorescence Confocal Microscopy Allow Faster Evaluation of Margin Clearance in Basal Cell Carcinomas in Mohs Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT03610620
- Acronym / sponsor ID
- FCM-P / 212591
- Conditions
- Basal Cell Carcinoma
- Keywords
- Basal cell carcinoma, Mohs surgery, Vivascope 2500 ex-vivo fluorescent confocal microscope, Frozen section Mohs histology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Julie DawsonUniversity, hospital or other
- Collaborators
- Mavig GmbH
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 9 Aug 2018 (actual)
- Study completion
- 9 Aug 2018 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is comparing the accuracy and speed of the Vivascope 2500 ex-vivo fluorescent confocal microscope with frozen section Mohs histology in evaluating clear margins in basal cell carcinoma in Mohs surgery.
Detailed description
Patients with basal cell carcinomas in the head and neck area, being considered for Mohs surgery with frozen sections will be invited to participate in this trial by the investigators when they attend for their pre-surgical consultation. They will be given sufficient time to review the information sheet and ask questions. When they attend for their Mohs surgery, they will be recruited if they wish to participate in this trial, at which point, the investigator, or an authorized member of their team, will obtain written informed consent for patients. The patient will then undergo Mohs surgery. The processing and interpretation with frozen sections will be conducted in the same way, the only difference being immediately after the BCC is excised with a Mohs bevelled edge (45o incision), the tissue is immersed in acridine orange (nuclear DNA stain) and placed upside down with the deep margin of the tissue face up. With a glass slide placed on top, we would place the FCM (Vivascope 2500) over this, scan the tissue and obtain mosaic images of the tissue which would be stitched together. The penetration of the FCM scan is approximately 0.25mm. This is approximately the distance between 2-3 Mohs wafers. The investigators would usually consider a margin of 3 Mohs wafers (300 microns) clear. When the scanning is completed (5 minutes), the Mohs layer would be sent for frozen section (stained with haematoxylin and eosin) for confirmation in the usual way. The Mohs surgeon can interpret the FCM mosaic images later. Acridine orange does not interfere with frozen sections or paraffin histopathological quality. No medicines will be used in this study. The information is collected on only 1 patient visit. There is no follow up period. The main objectives would (1) compare the accuracy in detection of BCC margins with FCM compared with FSM and (2) evaluate the time taken for processing and interpretation of FCM (acridine orange inking and rinsing, image acquisition and mosaic stitching, and image interpretation) compared with the time taken for processing and interpretation of FSM (sample flattening, freezing and cutting with the cryostat, H\&E staining, slide cover slipping and slide interpretation).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Compare accuracy and speed of the Vivascope 2500 to frozen sections.
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Procedure: Vivascope 2500 ex-vivo fluorescent confocal microscopeVivascope 2500 ex-vivo fluorescent confocal microscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Patient with basal cell carcinoma on the head and neck undergoing Mohs surgery with frozen sections
- Patient willing and able to give informed consent
- Patient treated not previously or currently treated with a hedgehog inhibitor medication (vismodegib)
- Patient suitable for Mohs surgery
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivascope 2500 ex-vivo fluorescent confocal microscopescanned with the Vivascope 2500 | Procedure or surgery | ARM A |
Primary outcome
To compare the specificity and sensitivity of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
Time frame: 1 DAY
Compare the specificity and sensitivity of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
1 secondary outcome
To compare the time taken for processing and interpretation of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions.
Time frame: 1 DAY
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunice Tan, Consultant principal investigator
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivascope 2500 ex-vivo fluorescent confocal microscope in people with Basal Cell Carcinoma, run by Julie Dawson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the specificity and sensitivity of the ex-vivo fluorescence confocal microscopy against frozen section histopathology in detecting residual BCC in Mohs excisions. (time frame: 1 DAY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.