Optical Frequency Domain Imaging for Non-melanoma Skin Cancers
Conditions
Non-Melanoma Skin Cancer (NMSC)
Conditions: official terms
Skin Neoplasms
Conditions: Keywords
skin cancer, optical imaging, optical coherence tomography, optical frequency domain imaging
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Intervention
Name: OFDI
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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

4. Subjects referred by primary dermatologist

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 using any drug that may increase or decrease local vasculature, locally or systematically, such as VEGF inhibitors (e.g. rapamycin), anticoagulants, and beta-blockers, or high dose corticosteroids sildenafil (Viagra ®)., topical lidocaine cream, etc.

4. Subjects receiving any topical treatment for actinic keratosis on the area where the imaging will be performed (e.g. 5-fluorouracil (Effudex®), imiquimod (Aldara®), diclofenac sodium (Solaraze®), etc)*

5. Subjects with any autoimmune disease (lupus erythematosus, sclerodermia, etc)

6. Subjects taking any topical /systemic chemotherapy or immunosuppressants

7. Subjects who are pregnant and/or breastfeeding

8. Subjects with tape adhesive allergies

- e.g.: If the lesion is located on the arms and the subject is applying the treatment on the face, this will not be an exclusion criteria.
Location
Massachusetts General Hospital
Boston, Massachusetts, United States
Status: Recruiting
Contact: Benjamin J Vakoc, PhD
Start Date
November 2013
Completion Date
December 2016
Sponsors
Massachusetts General Hospital
Source
Massachusetts General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page