Clinical trial · Interventional
Measurement of Digital Colposcopy for Fluorescence Spectroscopy of TNC Using a Second Device
A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of the Normal Cervix for Screening, Using a Second Generation Device
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed early with no enrollment.
Summary
Brief summary (as posted)
The overall objective of this study is to identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using Multi-spectral Digital Colposcopy (MDC), a device that uses fluorescence and reflectance spectroscopy to compare images to histopathologic mapping of the cervical epithelium. Primary Objective: -To measure Multi-spectral Digital Colposcopy images in vivo of the cervix both before and after acetic acid in a screening population.This is a second generation research device with low significant risk for which we are studying MDC. Secondary Objectives: 1. To evaluate the effect of the fading of acetic acid in the image contrast obtained over time to see if this fading can predict the presence of any neoplasia. 2. To evaluate mapping the cervix so that software can reconstruct the cervical epithelial map as evaluated by a Papanicolaou Smear to compare to routine colposcopic images as well as those from the Multi-spectral Digital Colposcopy (MDC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Neoplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-spectral Digital Colposcopy (MDC) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MDC
- description
- Multi-spectral Digital Colposcopy for Fluorescence Spectroscopy
- interventionNames
- Procedure: Multi-spectral Digital Colposcopy (MDC)
Primary outcomes (1)
- measure
- Number of participants with abnormal cell detection before and after acetic acid/colposcopy using Multi-spectral Digital Colposcopy (MDC)
- timeFrame
- Participation limited to Colposcopy visit, anticipate study completion in one day
- description
- Measurements of normal sites during colposcopy before and after the application of acetic acid using Multi-spectral Digital Colposcopy (MDC) images in vivo of the cervix both before and after acetic acid. Three images (white, blue, and green light) compared before and after acetic acid placement, the images may be compared to pathology obtained from a Pap Smear taken to evaluate the performance of the instrument.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women 18 years of age or older. 2. Women who have been referred for screening at U.T.M.D. Anderson Hospital, Houston, TX USA; U.T. Health Science Center-Houston,TX USA; Lyndon B. Johnson General Hospital, Houston, TX USA; British Columbia Cancer Agency, Vancouver, British Columbia, Canada; and the University College Hospital, Ibadan, Oyo State, Nigeria, Africa Cervical Screening Clinics, Family Planning Clinics or Gynecology Clinics. 3. Patients must sign an informed consent indicating awareness of the investigational nature of the study. Exclusion Criteria: 1. Patients will be considered ineligible if they are pregnant. 2. If they have a history of an abnormal Pap or a treatment to the cervix.
References
Publications (0)
Data not yet available