Combined Digital Colposcopy Analysis to Improve Cervical Precancer and Cancer Detection
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2018 |
| Start Date: | December 2012 |
| End Date: | November 9, 2016 |
Development and Application of a Multispectral Digital Colposcopy Algorithm for Detection of Cervical Intraepithelial Neoplasia and Neoplasia.
Precancerous lesions of the cervix occur frequently and are treatable. This justifies a
population-based screening program. Following an abnormal Pap smear, patients are referred
for a colposcopic exam to confirm the presence/stage of disease and select appropriate
treatments. Unfortunately, these approaches do not detect all lesions or can sometimes give
'false positive' results (resulting in overtreatment). We are testing a device called a
'multispectral digital colposcope' to determine whether it is more effective at detecting
precancerous cervical lesions than existing tools. Success in our study will make diagnoses
more accurate and reduce the costs associated with unnecessary treatments.
population-based screening program. Following an abnormal Pap smear, patients are referred
for a colposcopic exam to confirm the presence/stage of disease and select appropriate
treatments. Unfortunately, these approaches do not detect all lesions or can sometimes give
'false positive' results (resulting in overtreatment). We are testing a device called a
'multispectral digital colposcope' to determine whether it is more effective at detecting
precancerous cervical lesions than existing tools. Success in our study will make diagnoses
more accurate and reduce the costs associated with unnecessary treatments.
The multispectral digital colposcope (MDC) is a specialized lightsource and imaging device
mounted on a custom-made colposcope that acquires a sequence of fluorescence images. The MDC
also consists of a point probe that is used to take detailed light measurements (call
spectroscopy) from smaller regions of the cervix. The goal of the study is to see whether the
MDC can perform better than standard methods in detecting cancerous or pre-cancerous
abnormalities of the cervix.
Study subjects will be HPV swabbed. After vinegar is applied on the cervix as per usual
colposcopy practice, the MDC will then be used to take a sequence of images of the cervix.
Next 2-4 readings will be taken from the cervix using the point probe.
Study subjects may also be randomly asked to have additional pictures taken with another
imaging device. a) The Fast Fluorescence Camera (FFC) is a modified digital camera that will
capture images similar to that of the MDC. It will take a pair of images under two different
lighting conditions - white light and violet light, both of which are used by the MDC. b) The
Confocal Probe (CP) is a hand-held microscope used to collect images from the same location
as the point probe. The cervix is topically stained with a fluorescent dye (Acriflavine)
which is taken up by cell nuclei. The CP is then able to capture, in real time, images of the
cells and their fluorescent nuclei.
This data will be used to train, test and valid an algorithm specific to the MDC. The ability
of the algorithm to detect cervical intraepithelial neoplasia will be compared to standard
clinical care (colposcopy).
The MDC images and pathology results will be compared to the spectroscopy data from the MDC
probe. We will determine if spectroscopy has equal sensitivity to colposcopy for detecting
high grade lesions.
mounted on a custom-made colposcope that acquires a sequence of fluorescence images. The MDC
also consists of a point probe that is used to take detailed light measurements (call
spectroscopy) from smaller regions of the cervix. The goal of the study is to see whether the
MDC can perform better than standard methods in detecting cancerous or pre-cancerous
abnormalities of the cervix.
Study subjects will be HPV swabbed. After vinegar is applied on the cervix as per usual
colposcopy practice, the MDC will then be used to take a sequence of images of the cervix.
Next 2-4 readings will be taken from the cervix using the point probe.
Study subjects may also be randomly asked to have additional pictures taken with another
imaging device. a) The Fast Fluorescence Camera (FFC) is a modified digital camera that will
capture images similar to that of the MDC. It will take a pair of images under two different
lighting conditions - white light and violet light, both of which are used by the MDC. b) The
Confocal Probe (CP) is a hand-held microscope used to collect images from the same location
as the point probe. The cervix is topically stained with a fluorescent dye (Acriflavine)
which is taken up by cell nuclei. The CP is then able to capture, in real time, images of the
cells and their fluorescent nuclei.
This data will be used to train, test and valid an algorithm specific to the MDC. The ability
of the algorithm to detect cervical intraepithelial neoplasia will be compared to standard
clinical care (colposcopy).
The MDC images and pathology results will be compared to the spectroscopy data from the MDC
probe. We will determine if spectroscopy has equal sensitivity to colposcopy for detecting
high grade lesions.
Inclusion criteria:
- Included subjects will be ≥18 years old.
- Included subjects will not be pregnant or breast feeding.
- Included subjects will have a negative urine pregnancy test.
- Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH
Women's Clinic.
- Included subjects will indicate understanding of the study.
- Included subjects will provide informed consent to participate.
Exclusion criteria:
- Individuals <18 years old will be excluded.
- Pregnant and breast feeding individuals will be excluded.
- Individuals that have had an operation to remove their cervix will be excluded.
We found this trial at
3
sites
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Vancouver, British Columbia
Phone: 604-675-8093
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