search
Back to results

Optical Frequency Domain Imaging for Non-melanoma Skin Cancers (OFDI)

Primary Purpose

Non-Melanoma Skin Cancer (NMSC)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OFDI
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Non-Melanoma Skin Cancer (NMSC) focused on measuring skin cancer, optical imaging, optical coherence tomography, optical frequency domain imaging

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NMSC Imaging

Arm Description

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

Outcomes

Primary Outcome Measures

Successful imaging of lesion
Images acquired of NMSC

Secondary Outcome Measures

Full Information

First Posted
August 8, 2012
Last Updated
March 13, 2023
Sponsor
Massachusetts General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01662713
Brief Title
Optical Frequency Domain Imaging for Non-melanoma Skin Cancers
Acronym
OFDI
Official Title
Optical Frequency Domain Imaging for Non-melanoma Skin Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Non-melanoma skin cancer (NMSC) is the most common cancer in the United States, with more than 750,000 diagnosed patients treated every year. Its prevalence and incidence have significantly increased over the past two decades and it has been estimated that 20% of all Americans will develop this type of cancer during their lifetime (Neville et al., 2007). Biopsy and surgical resection of NMSC can result in tissue mutilation and scaring. Therefore, there is a need for new imaging technologies that can be used to non-invasively guide biopsy and surgery. Optical Frequency Domain Imaging (OFDI) is a second-generation imaging implementation of optical coherence tomography (OCT) developed at the Wellman Center. OFDI provides high-resolution three-dimensional imaging in tissue. It uses an interferometric depth-sectioning technique and employs a near-infrared light source. Through analysis of phase information in the recorded signal. OFDI can detect blood vessels within tissues and tumors. Importantly, OFDI-based vascular imaging can be performed without the need for exogenous contrast agents, making it relatively easy to deploy in clinical settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Melanoma Skin Cancer (NMSC)
Keywords
skin cancer, optical imaging, optical coherence tomography, optical frequency domain imaging

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NMSC Imaging
Arm Type
Experimental
Arm Description
Optical Frequency Domain Imaging (OFDI) will be used to look at non melanoma skin cancer (NMSC) lesion(s).
Intervention Type
Device
Intervention Name(s)
OFDI
Other Intervention Name(s)
Optical Imaging, Optical Coherence Tomography, OCT, Optical Frequency Domain Imaging
Intervention Description
Imaging of skin
Primary Outcome Measure Information:
Title
Successful imaging of lesion
Description
Images acquired of NMSC
Time Frame
After completion of imaging session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Vakoc, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Optical Frequency Domain Imaging for Non-melanoma Skin Cancers

We'll reach out to this number within 24 hrs