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Optical Frequency Domain Imaging for Non-melanoma Skin Cancers

Optical Frequency Domain Imaging for Non-melanoma Skin Cancers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01662713
Acronym
OFDI
Enrollment
10
Registered
2012-08-10
Start date
2017-03-01
Completion date
2019-12-01
Last updated
2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Melanoma Skin Cancer (NMSC)

Keywords

skin cancer, optical imaging, optical coherence tomography, optical frequency domain imaging

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.

Interventions

DEVICEOFDI

Imaging of skin

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Successful imaging of lesionAfter completion of imaging sessionImages acquired of NMSC

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026