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

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ClinicalTrials.gov Identifier: NCT01662713
Recruitment Status : Suspended (Performing Interim Analysis)
First Posted : August 10, 2012
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin Vakoc, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE August 8, 2012
First Posted Date  ICMJE August 10, 2012
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
Successful imaging of lesion [ Time Frame: After completion of imaging session ]
Images acquired of NMSC
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01662713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optical Frequency Domain Imaging for Non-melanoma Skin Cancers
Official Title  ICMJE Optical Frequency Domain Imaging for Non-melanoma Skin Cancers
Brief 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.
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.

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 3, 2014)
90
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2012)
10
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01662713
Other Study ID Numbers  ICMJE 2012P002430
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Benjamin Vakoc, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benjamin Vakoc, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2019

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