Trial Outcomes & Findings for Coherence Imaging of the Cervical Epithelium With Scanning a/LCI (NCT NCT03502798)
NCT ID: NCT03502798
Last Updated: 2021-02-18
Results Overview
Sensitivity of the scanning a/LCI probe's ability to detect cervical dysplasia determined by calculating the percentage of correctly identified positive optical biopsies measured by the scanning a/LCI probe when compared to the gold standard, histopathology. There are two dichotomies of classification used in this study: one that focuses on the morphological differences between cells (histology-based classification), and one that focuses on the urgency of corresponding treatment (response-based classification). In the histology-based classification, a result of benign alone is a negative result and a result of LSIL (low-grade squamous intraepithelial lesion) or HSIL (high-grade squamous epithelial lesion) is a positive result. In the response-based classification, both benign and LSIL are treated as negative results and HSIL is treated as a positive result.
COMPLETED
NA
45 participants
baseline
2021-02-18
Participant Flow
Participant milestones
| Measure |
Scanning a/LCI (Pilot)
Pilot study conducted at Duke University (Durham, NC). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. The scanning a/LCI probe was inserted into the vagina and placed against the cervix using direct visualization provided by a white light camera incorporated into the probe. Optical interferometric data were acquired to characterize the instrument's ability to detect cervical dysplasia via depth-resolved nuclear morphology measurements.
|
Scanning a/LCI (Jacobi)
Primary arm of present study, conducted at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. In addition, participants abstained from sexual intercourse for at least 24 hours prior to the study visit.
A speculum was inserted prior to the a/LCI probe for ease of tissue biopsy collection after a/LCI scanning. The scanning a/LCI probe was inserted through speculum and placed against the cervix using white light visual guidance from the probe's integrated camera. The a/LCI imaging sequence was initiated, with 36 scan points spaced across an area of 50 mm2. 80 a/LCI optical biopsy scans were at 4 selected biopsy sites (20 per quadrant). The a/LCI probe was removed and a Wallach colposcope was used to take a digital image of the cervix for co-registration with the a/LCI image. Some women underwent a previously scheduled loop electrosurgical excision procedure (LEEP) immediately following data collection; tissue biopsies were taken either with the assistance of the colposcope or during the LEEP and all specimens were analyzed by pathologists to provide a histological diagnosis for comparison with the a/LCI measurements. Tissue biopsies for each quadrant were assigned a classification (negative, CIN-1, CIN-2, or CIN-3) as well as notes for any additional findings (koilocytic atypia, abnormal acetowhite epithelium, etc.).
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
40
|
|
Overall Study
COMPLETED
|
5
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
Reasons for withdrawal
| Measure |
Scanning a/LCI (Pilot)
Pilot study conducted at Duke University (Durham, NC). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. The scanning a/LCI probe was inserted into the vagina and placed against the cervix using direct visualization provided by a white light camera incorporated into the probe. Optical interferometric data were acquired to characterize the instrument's ability to detect cervical dysplasia via depth-resolved nuclear morphology measurements.
|
Scanning a/LCI (Jacobi)
Primary arm of present study, conducted at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. In addition, participants abstained from sexual intercourse for at least 24 hours prior to the study visit.
A speculum was inserted prior to the a/LCI probe for ease of tissue biopsy collection after a/LCI scanning. The scanning a/LCI probe was inserted through speculum and placed against the cervix using white light visual guidance from the probe's integrated camera. The a/LCI imaging sequence was initiated, with 36 scan points spaced across an area of 50 mm2. 80 a/LCI optical biopsy scans were at 4 selected biopsy sites (20 per quadrant). The a/LCI probe was removed and a Wallach colposcope was used to take a digital image of the cervix for co-registration with the a/LCI image. Some women underwent a previously scheduled loop electrosurgical excision procedure (LEEP) immediately following data collection; tissue biopsies were taken either with the assistance of the colposcope or during the LEEP and all specimens were analyzed by pathologists to provide a histological diagnosis for comparison with the a/LCI measurements. Tissue biopsies for each quadrant were assigned a classification (negative, CIN-1, CIN-2, or CIN-3) as well as notes for any additional findings (koilocytic atypia, abnormal acetowhite epithelium, etc.).
|
|---|---|---|
|
Overall Study
equipment failure
|
0
|
7
|
Baseline Characteristics
Age was not recorded for 2 participants in the Jacobi arm.
Baseline characteristics by cohort
| Measure |
Scanning a/LCI (Pilot)
n=5 Participants
Pilot study conducted at Duke University (Durham, NC). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test.
The scanning a/LCI probe was inserted into the vagina and placed against the cervix using direct visualization provided by a white light camera incorporated into the probe. Optical interferometric data were acquired to characterize the instrument's ability to detect cervical dysplasia via depth-resolved nuclear morphology measurements.
|
Scanning a/LCI (Jacobi)
n=40 Participants
Primary arm of present study, conducted at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. In addition, participants abstained from sexual intercourse for at least 24 hours prior to the study visit.
A speculum was inserted prior to the a/LCI probe for ease of tissue biopsy collection after a/LCI scanning. The scanning a/LCI probe was inserted through speculum and placed against the cervix using white light visual guidance from the probe's integrated camera. The a/LCI imaging sequence was initiated, with 36 scan points spaced across an area of 50 mm2. 80 a/LCI optical biopsy scans were at 4 selected biopsy sites (20 per quadrant). The a/LCI probe was removed and a Wallach colposcope was used to take a digital image of the cervix for co-registration with the a/LCI image. Some women underwent a previously scheduled loop electrosurgical excision procedure (LEEP) immediately following data collection; tissue biopsies were taken either with the assistance of the colposcope or during the LEEP and all specimens were analyzed by pathologists to provide a histological diagnosis for comparison with the a/LCI measurements. Tissue biopsies for each quadrant were assigned a classification (negative, CIN-1, CIN-2, or CIN-3) as well as notes for any additional findings (koilocytic atypia, abnormal acetowhite epithelium, etc.).
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
n=5 Participants • Age was not recorded for 2 participants in the Jacobi arm.
|
35 years
n=38 Participants • Age was not recorded for 2 participants in the Jacobi arm.
|
34 years
n=43 Participants • Age was not recorded for 2 participants in the Jacobi arm.
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
40 Participants
n=40 Participants
|
45 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
23 Participants
n=40 Participants
|
23 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
14 Participants
n=40 Participants
|
19 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=40 Participants
|
3 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
11 Participants
n=40 Participants
|
13 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
17 Participants
n=40 Participants
|
19 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
11 Participants
n=40 Participants
|
11 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: 40 women enrolled at the Jacobi site, but successful a/LCI scans were only acquired from 20 participants due to equipment failures (mechanical breaks in probe, electrical component failures, software errors). For each participant analyzed, optical biopsies (a/LCI scans) and corresponding physical tissue biopsies were collected at four sites (12, 3, 6, and 9 o'clock). No pilot study participants were analyzed as no physical tissue biopsies were done in the pilot phase.
Sensitivity of the scanning a/LCI probe's ability to detect cervical dysplasia determined by calculating the percentage of correctly identified positive optical biopsies measured by the scanning a/LCI probe when compared to the gold standard, histopathology. There are two dichotomies of classification used in this study: one that focuses on the morphological differences between cells (histology-based classification), and one that focuses on the urgency of corresponding treatment (response-based classification). In the histology-based classification, a result of benign alone is a negative result and a result of LSIL (low-grade squamous intraepithelial lesion) or HSIL (high-grade squamous epithelial lesion) is a positive result. In the response-based classification, both benign and LSIL are treated as negative results and HSIL is treated as a positive result.
Outcome measures
| Measure |
Scanning a/LCI (Pilot)
Pilot study conducted at Duke University (Durham, NC). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test.
The scanning a/LCI probe was inserted into the vagina and placed against the cervix using direct visualization provided by a white light camera incorporated into the probe. Optical interferometric data were acquired to characterize the instrument's ability to detect cervical dysplasia via depth-resolved nuclear morphology measurements.
|
Scanning a/LCI (Jacobi)
n=80 biopsies
Primary arm of present study, conducted at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. In addition, participants abstained from sexual intercourse for at least 24 hours prior to the study visit.
A speculum was inserted prior to the a/LCI probe for ease of tissue biopsy collection after a/LCI scanning. The scanning a/LCI probe was inserted through speculum and placed against the cervix using white light visual guidance from the probe's integrated camera. The a/LCI imaging sequence was initiated, with 36 scan points spaced across an area of 50 mm2. 80 a/LCI optical biopsy scans were at 4 selected biopsy sites (20 per quadrant). The a/LCI probe was removed and a Wallach colposcope was used to take a digital image of the cervix for co-registration with the a/LCI image. Some women underwent a previously scheduled loop electrosurgical excision procedure (LEEP) immediately following data collection; tissue biopsies were taken either with the assistance of the colposcope or during the LEEP and all specimens were analyzed by pathologists to provide a histological diagnosis for comparison with the a/LCI measurements. Tissue biopsies for each quadrant were assigned a classification (negative, CIN-1, CIN-2, or CIN-3) as well as notes for any additional findings (koilocytic atypia, abnormal acetowhite epithelium, etc.).
|
|---|---|---|
|
Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies
histology-based classification
|
—
|
90.3 percentage of correct identifications
Interval 74.2 to 98.0
|
|
Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies
response-based classification
|
—
|
100.0 percentage of correct identifications
Interval 73.5 to 100.0
|
PRIMARY outcome
Timeframe: baselinePopulation: 40 women enrolled at the Jacobi site, but successful a/LCI scans were only acquired from 20 participants due to equipment failures (mechanical breaks in probe, electrical component failures, software errors). For each participant analyzed, optical biopsies (a/LCI scans) and corresponding physical tissue biopsies were collected at four sites (12, 3, 6, and 9 o'clock). No pilot study participants were analyzed as no physical tissue biopsies were done in the pilot phase.
Specificity of the scanning a/LCI probe's ability to detect cervical dysplasia determined by calculating the percentage of correctly identified negative optical biopsies measured by the scanning a/LCI probe when compared to the gold standard, histopathology. There are two dichotomies of classification used in this study: one that focuses on the morphological differences between cells (histology-based classification), and one that focuses on the urgency of corresponding treatment (response-based classification). In the histology-based classification, a result of benign alone is a negative result and a result of LSIL (low-grade squamous intraepithelial lesion) or HSIL (high-grade squamous intraepithelial lesion) is a positive result. In the response-based classification, both benign and LSIL are treated as negative results and HSIL is treated as a positive result.
Outcome measures
| Measure |
Scanning a/LCI (Pilot)
Pilot study conducted at Duke University (Durham, NC). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test.
The scanning a/LCI probe was inserted into the vagina and placed against the cervix using direct visualization provided by a white light camera incorporated into the probe. Optical interferometric data were acquired to characterize the instrument's ability to detect cervical dysplasia via depth-resolved nuclear morphology measurements.
|
Scanning a/LCI (Jacobi)
n=80 biopsies
Primary arm of present study, conducted at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. In addition, participants abstained from sexual intercourse for at least 24 hours prior to the study visit.
A speculum was inserted prior to the a/LCI probe for ease of tissue biopsy collection after a/LCI scanning. The scanning a/LCI probe was inserted through speculum and placed against the cervix using white light visual guidance from the probe's integrated camera. The a/LCI imaging sequence was initiated, with 36 scan points spaced across an area of 50 mm2. 80 a/LCI optical biopsy scans were at 4 selected biopsy sites (20 per quadrant). The a/LCI probe was removed and a Wallach colposcope was used to take a digital image of the cervix for co-registration with the a/LCI image. Some women underwent a previously scheduled loop electrosurgical excision procedure (LEEP) immediately following data collection; tissue biopsies were taken either with the assistance of the colposcope or during the LEEP and all specimens were analyzed by pathologists to provide a histological diagnosis for comparison with the a/LCI measurements. Tissue biopsies for each quadrant were assigned a classification (negative, CIN-1, CIN-2, or CIN-3) as well as notes for any additional findings (koilocytic atypia, abnormal acetowhite epithelium, etc.).
|
|---|---|---|
|
Specificity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Negative Optical Biopsies
histology-based classification
|
—
|
81.6 percentage of correct identifications
Interval 68.0 to 91.2
|
|
Specificity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Negative Optical Biopsies
response-based classification
|
—
|
70.6 percentage of correct identifications
Interval 58.3 to 81.0
|
SECONDARY outcome
Timeframe: baselinePopulation: Data not collected due to frequent instrument repairs.
Ability of scanning a/LCI probe to correctly identify transformation zone (T-zone) compared to colpophotography
Outcome measures
Outcome data not reported
Adverse Events
Scanning a/LCI (Pilot)
Scanning a/LCI (Jacobi)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place