Completed

OFDIOptical Frequency Domain Imaging for Non-melanoma Skin Cancers

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What is being tested

OFDI

Device
Who is being recruted

Neoplasms+2

+ Neoplasms by Site

+ Skin Diseases

From 18 to 80 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Device Feasibility Study

Interventional
Study Start: March 2017
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: March 15, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2017

Actual date on which the first participant was enrolled.

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.

Principal SponsorMassachusetts General Hospital
Last updated: March 15, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Device Feasibility Study

These studies test whether a new medical device (like a tool or piece of equipment) is safe and practical to use. They're usually small and focus on how the device works rather than how well it treats a condition.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesSkin Neoplasms

Criteria

3 inclusion criteria required to participate
Male or female subjects with Fitzpatrick skin type I-VI

Presence of at least one NMSC lesion

Subjects with ages between 18 and 80 years of age

5 exclusion criteria prevent from participating
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 active localized or systemic infections

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps
CompletedOne Study Center