Clinical trial NCT01094132: Combined Digital Colposcopy Analysis to Improve Cervical Precancer and Cancer Detection
Official title: Development and Application of a Multispectral Digital Colposcopy Algorithm for Detection of Cervical Intraepithelial Neoplasia and Neoplasia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Precancerous Condition
Keywords: cervical cancer
cervical intraepithelial neoplasia grade 1
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3
Nonmalignant Condition
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Texas Tech University Health Sciences Center
name: Brookdale University Hospital Medical Center
name: William Marsh Rice University
name: The University of Texas Health Science Center, Houston
name: M.D. Anderson Cancer Center
First posted: 2010-03-26
Enrollment: 551
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detection of cancer or pre-cancerous abnormalities of the cervix by multispectral digital colposcope.
timeFrame: Standard colposcopy and trial device (MDC + wand) results will be obtained during the clinic visit. Histopathological results for comparison will be available within a few days of the clinic visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Brookdale Hospital and Medical Center
state: New York
city: El Paso
country: United States
facility: Texas Tech Health Sciences Center
state: Texas
city: Vancouver
country: Canada
facility: Vancouver General Hospital - Women's Clinic (G&L Diamond Centre)
state: British Columbia
Study officials:
affiliation: Brookdale Hospital and Medical Center
name: Michele Follen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: