Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503919
Status:
WITHDRAWN
Last Update Posted:
2016-04-08
First Post:
2007-07-17
Brief Title:
Measurement of Digital Colposcopy for Fluorescence Spectroscopy of TNC Using a Second Device
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Pilot Study Measurement of Digital Colposcopy for Fluorescence Spectroscopy of the Normal Cervix for Screening Using a Second Generation Device
Status:
WITHDRAWN
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed early with no enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 populationThis 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
Primary Objective
-To measure Multi-spectral Digital Colposcopy images in vivo of the cervix both before and after acetic acid in a screening populationThis 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
Detailed Description:
A colposcopy is an exam of the vagina and cervix using a magnifying lens A multi-spectral digital colposcopy uses a digital camera and a special light to take pictures of the cervix and vagina
Before taking part in this study you will have a complete medical history recorded You will have a physical exam and a pap smear Women who are able to have children must have a negative urine pregnancy test
You will then have a multi-spectral digital colposcopy performed during the routine colposcopy in the outpatient clinic A multi-spectral digital colposcopy device will shine light on the cervix and vagina and take several pictures The pictures will be used by the doctors to check the cells and structure of the tissue After the first set of pictures acetic acid vinegar will be applied to the cervix so any lesions would show up better Application of acetic acid is a normal part of the colposcopy and not part of the research About 1-2 minutes later more pictures will be taken
If the acetic acidcolposcopy show abnormal cells you will have a biopsy of the cervical canal
If the acetic acid colposcopy show normal cells no biopsy will be taken
Once you have completed the colposcopy with or without the biopsy of the cervical canal your participation on this study is complete
If either your Pap smear or biopsy of the cervical canal is abnormal the study doctorstaff will recommend further care or treatment
Before taking part in this study you will have a complete medical history recorded You will have a physical exam and a pap smear Women who are able to have children must have a negative urine pregnancy test
You will then have a multi-spectral digital colposcopy performed during the routine colposcopy in the outpatient clinic A multi-spectral digital colposcopy device will shine light on the cervix and vagina and take several pictures The pictures will be used by the doctors to check the cells and structure of the tissue After the first set of pictures acetic acid vinegar will be applied to the cervix so any lesions would show up better Application of acetic acid is a normal part of the colposcopy and not part of the research About 1-2 minutes later more pictures will be taken
If the acetic acidcolposcopy show abnormal cells you will have a biopsy of the cervical canal
If the acetic acid colposcopy show normal cells no biopsy will be taken
Once you have completed the colposcopy with or without the biopsy of the cervical canal your participation on this study is complete
If either your Pap smear or biopsy of the cervical canal is abnormal the study doctorstaff will recommend further care or treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None