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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Benjamin Vakoc, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01662713
First received: August 8, 2012
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Non-Melanoma Skin Cancer (NMSC)
Device: OFDI

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Optical Frequency Domain Imaging for Non-melanoma Skin Cancers

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Successful imaging of lesion [ Time Frame: After completion of imaging session ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NMSC Imaging
Optical Frequency Domain Imaging (OFDI) will be used to look at non melanoma skin cancer (NMSC) lesion(s).
Device: OFDI
Other Names:
  • Optical Imaging
  • Optical Coherence Tomography
  • OCT
  • Optical Frequency Domain Imaging

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  4. Subjects referred by primary dermatologist

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 using any drug that may increase or decrease local vasculature, locally or systematically, such as VEGF inhibitors (e.g. rapamycin), anticoagulants, and beta-blockers, or high dose corticosteroids sildenafil (Viagra ®)., topical lidocaine cream, etc.
  4. Subjects receiving any topical treatment for actinic keratosis on the area where the imaging will be performed (e.g. 5-fluorouracil (Effudex®), imiquimod (Aldara®), diclofenac sodium (Solaraze®), etc)*
  5. Subjects with any autoimmune disease (lupus erythematosus, sclerodermia, etc)
  6. Subjects taking any topical /systemic chemotherapy or immunosuppressants
  7. Subjects who are pregnant and/or breastfeeding
  8. Subjects with tape adhesive allergies

    • e.g.: If the lesion is located on the arms and the subject is applying the treatment on the face, this will not be an exclusion criteria.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662713

Contacts
Contact: Fernanada Sakamoto, MD fsakamoto@partners.org
Contact: Benjamin Vakoc, PhD bvakoc@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Benjamin J Vakoc, PhD    617-726-0695    bvakoc@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Benjamin Vakoc, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Benjamin Vakoc, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01662713     History of Changes
Other Study ID Numbers: 2012P002430
Study First Received: August 8, 2012
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
skin cancer
optical imaging
optical coherence tomography
optical frequency domain imaging

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014