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Coherence Imaging of the Cervical Epithelium

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ClinicalTrials.gov Identifier: NCT02903394
Recruitment Status : Completed
First Posted : September 16, 2016
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Jacobi Medical Center
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Cervical Epithelia
Intervention Device: mLCI Device
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title mLCI Imaging (Pilot) mLCI Imaging (Jacobi)
Hide Arm/Group Description Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.

Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.

Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type.

Period Title: Overall Study
Started 5 50
Completed 5 50
Not Completed 0 0
Arm/Group Title mLCI Imaging (Pilot) mLCI Imaging (Jacobi) Total
Hide Arm/Group Description Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.

Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.

Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type.

Total of all reporting groups
Overall Number of Baseline Participants 5 50 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 50 participants 55 participants
29.8
(24 to 34)
29.4
(18 to 42)
29.4
(18 to 42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 50 participants 55 participants
Female
5
 100.0%
50
 100.0%
55
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 50 participants 55 participants
Hispanic or Latino
0
   0.0%
16
  32.0%
16
  29.1%
Not Hispanic or Latino
5
 100.0%
34
  68.0%
39
  70.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 50 participants 55 participants
American Indian or Alaska Native
0
   0.0%
1
   2.0%
1
   1.8%
Asian
0
   0.0%
2
   4.0%
2
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  40.0%
26
  52.0%
28
  50.9%
White
3
  60.0%
5
  10.0%
8
  14.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
16
  32.0%
16
  29.1%
1.Primary Outcome
Title Number of Patients With Interferometric Data Acquired From Cervical Epithelium
Hide Description measured by: ability to receive interferometric data from at least one portion of the cervical epithelium
Time Frame day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title mLCI Imaging (Pilot) mLCI Imaging (Jacobi)
Hide Arm/Group Description:
Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.

Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.

Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type.

Overall Number of Participants Analyzed 5 50
Measure Type: Number
Unit of Measure: patients
3 41
2.Secondary Outcome
Title Number of Patients With Automated Classification of Cervical Epithelium
Hide Description The number of patients for which an interferometric tissue classification was made using optical mLCI data
Time Frame day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from whom epithelial interferometric data were successfully captured and for whom a corresponding colposcope image could be registered. No pilot study patients were included as no colposcopic examination was conducted in the pilot phase.
Arm/Group Title mLCI Imaging (Pilot) mLCI Imaging (Jacobi)
Hide Arm/Group Description:
Pilot study. 5 women from ages 24 to 34recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.

Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.

Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type.

Overall Number of Participants Analyzed 0 41
Measure Type: Number
Unit of Measure: patients
36
3.Secondary Outcome
Title Number and Frequency of Adverse Events
Hide Description Number of adverse events experienced by patients during the mLCI study.
Time Frame day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title mLCI Imaging (Pilot) mLCI Imaging (Jacobi)
Hide Arm/Group Description:
Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.

Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.

Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type.

Overall Number of Participants Analyzed 5 50
Measure Type: Number
Unit of Measure: events
0 0
Time Frame Day of study only
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title mLCI Imaging (Pilot) mLCI Imaging (Jacobi)
Hide Arm/Group Description Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.

Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.

Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type.

All-Cause Mortality
mLCI Imaging (Pilot) mLCI Imaging (Jacobi)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/50 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
mLCI Imaging (Pilot) mLCI Imaging (Jacobi)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
mLCI Imaging (Pilot) mLCI Imaging (Jacobi)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/50 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kengyeh Chu
Organization: Duke University
Phone: 919-681-2093
EMail: ken.chu@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02903394     History of Changes
Other Study ID Numbers: Pro00070555
R01CA167421 ( U.S. NIH Grant/Contract )
First Submitted: September 1, 2016
First Posted: September 16, 2016
Results First Submitted: October 17, 2018
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018