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OpenTrials
Completed

NCT Number: NCT01662713

Optical Frequency Domain Imaging for Non-melanoma Skin Cancers

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects with Fitzpatrick skin type I-VI
  • Subjects with ages between 18 and 80 years of age
  • Presence of at least one NMSC lesion

Exclusion criteria

  • Subjects with active localized or systemic infections
  • Subjects participating in potentially confounding clinical studies of investigational therapies, either drug or device.
  • Subjects taking any topical/systemic chemotherapy or immunosuppressants
  • Subjects who are pregnant and/or breastfeeding
  • Subjects with tape adhesive allergies

Treatment and study plan

OFDI

Device

Imaging of skin

Other names: Optical Imaging, Optical Coherence Tomography, OCT, Optical Frequency Domain Imaging

Primary outcomes

  1. Successful imaging of lesion

    Time frame: After completion of imaging session

    Images acquired of NMSC

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: OFDI

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2012
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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