Optical Frequency Domain Imaging for Non-melanoma Skin Cancers

Not Applicable

Completed

• Conditions: Non-Melanoma Skin Cancer (NMSC)
• Interventions: Device: OFDI

• Registration Number: NCT01662713
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-10
• Study Start: 2017-03-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Successful imaging of lesion	After completion of imaging session	Images acquired of NMSC

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States