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Optical Frequency Domain Imaging for Non-melanoma Skin Cancers (OFDI)

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ClinicalTrials.gov Identifier: NCT01662713
Recruitment Status : Recruiting
First Posted : August 10, 2012
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin Vakoc, Massachusetts General Hospital

August 8, 2012
August 10, 2012
May 22, 2018
March 1, 2017
December 2018   (Final data collection date for primary outcome measure)
Successful imaging of lesion [ Time Frame: After completion of imaging session ]
Images acquired of NMSC
Not Provided
Complete list of historical versions of study NCT01662713 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Optical Frequency Domain Imaging for Non-melanoma Skin Cancers
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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Non-Melanoma Skin Cancer (NMSC)
Device: OFDI
Imaging of skin
Other Names:
  • Optical Imaging
  • Optical Coherence Tomography
  • OCT
  • Optical Frequency Domain Imaging
Experimental: NMSC Imaging
Optical Frequency Domain Imaging (OFDI) will be used to look at non melanoma skin cancer (NMSC) lesion(s).
Intervention: Device: OFDI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
10
June 2019
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact: Benjamin Vakoc, PhD 617-726-0695 bvakoc@partners.org
Contact: Benjamin Vakoc, PhD
United States
 
 
NCT01662713
2012P002430
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Benjamin Vakoc, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Benjamin Vakoc, PhD Massachusetts General Hospital
Massachusetts General Hospital
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP