Optical Frequency Domain Imaging for Non-melanoma Skin Cancers



Status:Suspended
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:3/9/2019
Start Date:March 1, 2017
End Date:December 2019

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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.

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.

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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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