NCT01662713

Brief Summary

The purpose of this research study is to find out if a non-invasive imaging device called Optical Frequency Domain Imaging (OFDI) can help doctors to see the tissue and blood vessels that are related to non-melanoma skin cancers. OFDI was designed to see microscopic details of your skin without needing to use any invasive techniques such as surgery or biopsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
4.6 years until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

2.8 years

First QC Date

August 8, 2012

Last Update Submit

March 13, 2023

Conditions

Non-Melanoma Skin Cancer (NMSC)

Keywords

skin canceroptical imagingoptical coherence tomographyoptical frequency domain imaging

Outcome Measures

Primary Outcomes (1)

  • Successful imaging of lesion

    Images acquired of NMSC

    After completion of imaging session

Study Arms (1)

NMSC Imaging

EXPERIMENTAL

Optical Frequency Domain Imaging (OFDI) will be used to look at non melanoma skin cancer (NMSC) lesion(s).

Device: OFDI

Interventions

OFDIDEVICE

Imaging of skin

Also known as: Optical Imaging, Optical Coherence Tomography, OCT, Optical Frequency Domain Imaging
NMSC Imaging

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects with Fitzpatrick skin type I-VI
  • Subjects with ages between 18 and 80 years of age
  • Presence of at least one NMSC lesion

You may not qualify if:

  • Subjects with active localized or systemic infections
  • Subjects participating in potentially confounding clinical studies of investigational therapies, either drug or device.
  • Subjects taking any topical/systemic chemotherapy or immunosuppressants
  • Subjects who are pregnant and/or breastfeeding
  • Subjects with tape adhesive allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Optical ImagingTomography, Optical Coherence

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesTomography, OpticalTomography

Study Officials

  • Benjamin Vakoc, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 10, 2012

Study Start

March 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations

US(1)