CClinicalTrials.gg
TerminatedNCT03420846Updated Jan 28, 2020

Efficiency of Presurgical Basal Cell Carcinoma Margin Mapping

An interventional study of OCT Mapped in Carcinoma, Basal Cell, sponsored by Michelson Diagnostics Ltd.. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-28.

Sponsored by Michelson Diagnostics Ltd. · Not applicable, Interventional, and Treatment

Why this study was terminated
Funding exhausted. Sufficient data already collected.
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This Interventional Randomised Controlled study is intended to establish that presurgical margin mapping of BCCs with OCT results in a reduction of the number of MMS surgery stages without adversely impacting clinical outcome, resulting in shorter patient stays and more efficient use of surgical and operating room resources.

Read the detailed description

Basal Cell Carcinoma (BCC) is the most common malignancy in humans. Its incidence is continuously increasing. The head and neck areas are most commonly affected due to their increased lifetime exposure to sun compared to other body parts. BCC is often treated by surgical excision which has high cure rate compared to other treatment modalities, but leaves a visible scar which can affect the quality of life of the patient, depending on the location and size of the excision. Mohs Micrographic Surgery (MMS) was developed to minimize the size of the surgical excision whilst maintaining very high cure rate. The main drawback of MMS is that repeated surgery procedures are usually required to eliminate all of the tumour using specialist resources located at the clinic.

Optical Coherence Tomography (OCT) allows non-invasive in-vivo imaging of superficial skin lesions. It is in routine clinical use for diagnosis of BCCs, and the diagnostic sensitivity and specificity is well established in published multi-centre trials. A further potential application of OCT is the pre-surgical mapping of the lateral margins of BCC. If the margins of a BCC were accurately known prior to commencing an MMS treatment, the treatment could be performed much more quickly, resulting in shorter patient stays and more efficient use of surgical and operating room resources. Previously published research has already shown that OCT mapping of BCC margins is more accurate than clinical assessment; the objective of the present study is to demonstrate that pre-surgical mapping of BCC margins with OCT is also more efficient.

02

Conditions studied

  • Carcinoma, Basal Cell
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients with biopsy-proven BCCs who have been referred for MMS

Exclusion criteria

Exclusion Criteria:

  • Patients with BCCs larger than 6 cm2
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    OCT Mapped arm

    OCT is used to map the tumour margins as the first stage MMS estimate

    Other: OCT Mapped

  • No intervention
    Control arm

    Standard MMS is performed

Interventions

  • OtherOCT Mapped

    Presurgical mapping of Basal Cell Carcinoma margins

05

What researchers measure

Primary outcomes

  1. Average number of Mohs stages

    Is the average number of Mohs stages \< 1.4 with a 95% confidence level. (P \< 0.025)

    Time frame: 1 day

Secondary outcomes

  1. Size of the surgical defect

    Validate that the reduction in MMS stages by use of OCT mapping does not result in an increase in the size of the surgical defect

    Time frame: 1 day

  2. Average time taken to perform OCT margin mapping

    Show that the average time taken to perform OCT margin mapping is \< 5 minutes for lesions of area \< 2 cm2

    Time frame: 1 day

06

Study locations

1 site
  • SkinCare Network
    London, SW10 9PJ, United Kingdom
07

References and documents

Study documents

  • Informed consent form · Jan 19, 2018
  • Study protocol · Jan 19, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03420846
Lead sponsor
Michelson Diagnostics Ltd.
Collaborators
Skin Care Network Ltd.
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
Jul 1, 2018
Primary completion
Sep 1, 2019
Completion
Sep 1, 2019
Last update
Jan 28, 2020

Study contacts

Howard Stevens
principal investigator · Skin Care Network Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion