Optical Frequency Domain Imaging for Non-melanoma Skin Cancers

Non-Melanoma Skin Cancer (NMSC) Clinical Trial

— OFDI  

Official title:

Optical Frequency Domain Imaging for Non-melanoma Skin Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662713
• Other study ID #: 2012P002430
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Non-Melanoma Skin Cancer (NMSC)
• Skin Neoplasms

Intervention

Device:
• OFDI
Imaging of skin

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful imaging of lesion	Images acquired of NMSC	After completion of imaging session