NCT02666833

Brief Summary

The purpose of the study is to evaluate the ability and efficacy of using a polarization-enhanced reflectance and fluorescence imaging device, PERFIS, (see the Device Brochure) for demarcation of nonmelanoma skin cancer margins prior to surgery. PERFIS is a harmless and non-invasive device that has been used to image biological tissue both in vitro and in vivo. In this study it will be used to image nonmelanoma skin cancer lesions prior to surgery. The use of PERFIS will not affect patient care or treatment decisions in any way. No extra tissue will be used for imaging.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

January 21, 2016

Last Update Submit

September 14, 2016

Conditions

Carcinoma, Basal CellCarcinoma, Squamous Cell

Keywords

Skin CancerBasal Cell CarcinomaSquamous Cell CarcinomaMohs SurgeryImaging

Outcome Measures

Primary Outcomes (1)

  • Success or Failure of PERFIS in guiding pre-surgical marking

    Success of PERFIS: If tumor margins are clear, and the PERFIS image indicates that collagen distortion lies within the pre-surgical marking of the surgeon, this would indicate that PERFIS could be useful in guiding pre-surgical marking. OR If tumor margins are positive, and PERFIS images detect collagen distortion in the area of tumor positivity such that the surgeon's pre-surgical marking would be altered to include more inconspicuous tumor, then the PERFIS analysis will be graded as successful. Failure of PERFIS: If tumor margins are clear, and the PERFIS image indicates the presence of collagen distortion beyond the surgeon's original marking, this would indicate failure of PERFIS to provide utility in guiding pre-surgical marking. OR If areas of the PERFIS image show distortion in both normal margins and in areas with histologically-proven tumor, then PERFIS will be graded as a failure.

    1 hour

Interventions

Polarization Enhanced Reflectance and Fluorescence SystemDEVICE

Subjects will receive preoperative imaging of their skin cancer with the PERFIS optical imaging device.

Also known as: PERFIS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who receive their dermatologic care at the Massachusetts General Hospital Dermatologic Surgery Unit, who have at least one biopsy-proven nonmelanoma skin cancer, scheduled to be treated by Mohs micrographic surgery.

You may qualify if:

  • Male or female subjects, aged 18 and older, of any race or skin type
  • At least one biopsy-proven nonmelanoma skin cancer, scheduled to be treated by Mohs micrographic surgery

You may not qualify if:

  • Pregnant women
  • Patients with tumors within 1 cm of the eye
  • Patients with tumors larger than 2 cm in diameter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

  • Salasche SJ, Amonette RA. Morpheaform basal-cell epitheliomas. A study of subclinical extensions in a series of 51 cases. J Dermatol Surg Oncol. 1981 May;7(5):387-94. doi: 10.1111/j.1524-4725.1981.tb00662.x. No abstract available.

    PMID: 7240543BACKGROUND

  • Wolf DJ, Zitelli JA. Surgical margins for basal cell carcinoma. Arch Dermatol. 1987 Mar;123(3):340-4.

    PMID: 3813602BACKGROUND

  • Feng X, Patel R, Yaroslavsky AN. Wavelength optimized cross-polarized wide-field imaging for noninvasive and rapid evaluation of dermal structures. J Biophotonics. 2015 Apr;8(4):324-31. doi: 10.1002/jbio.201400105. Epub 2015 Jan 19.

    PMID: 25601353BACKGROUND

  • Feng X, Doherty S, Yaroslavsky I, Altshuler G, Yaroslavsky AN. Polarization enhanced wide-field imaging for evaluating dermal changes caused by non-ablative fractional laser treatment. Lasers Surg Med. 2016 Feb;48(2):150-6. doi: 10.1002/lsm.22390. Epub 2015 Aug 25.

    PMID: 26304187BACKGROUND

MeSH Terms

Conditions

Carcinoma, Basal CellCarcinoma, Squamous CellSkin Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms, Squamous CellNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Dermatologic Surgery

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 28, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

US(1)