Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513123
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2007-08-07
Brief Title:
Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia
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 Cervical Intraepithelial Neoplasia
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 digital colposcopy for colposcopy for fluorescence spectroscopy
Other Objectives
To measure digital fluorescence and reflectance images in vivo of sites in the human cervix
To evaluate the effect of acetic acid in the image contrast obtained
Compare the device performance to colposcopy and pathologic analysis of tissue removed at colposcopy
Other Objectives
To measure digital fluorescence and reflectance images in vivo of sites in the human cervix
To evaluate the effect of acetic acid in the image contrast obtained
Compare the device performance to colposcopy and pathologic analysis of tissue removed at colposcopy
Detailed Description:
DCF may provide a better way to detect or treat lesions of the cervix Women in the study will already be scheduled for colposcopy to detect or treat lesions of the cervix A colposcopy is an exam of the vagina and cervix using a magnifying lens
DCF will be done during the routine colposcopy in the outpatient clinic A digital colposcope DC device will be used to take a sequence of images of the cervix and vagina A DC is a digital camera connected to the colposcope with a specialized light source It will shine light on the cervix and acquire a sequence images The images will tell doctors about the cells and structure of the tissue After the first set of images acetic acid will be applied to the cervix so that lesions show up better and 1-2 minutes later more readings will be taken
Small samples of areas of abnormal tissue will be removed during colposcopy Taking these tissue samples is a routine part of this type of exam If patients are having colposcopy and loop electrosurgical excision procedure LEEP treatment one sample of normal tissue will be taken The cervix will be numbed for this procedure DCF images will be compared with lab findings from these samples Before DCF is done as standard of care patients will have a complete history and physical exam urine pregnancy test pap smear and cultures for gonorrhea chlamydia and viral testing
This is an investigational study About 114 women will take part in this study About 22 will be enrolled at M D Anderson
DCF will be done during the routine colposcopy in the outpatient clinic A digital colposcope DC device will be used to take a sequence of images of the cervix and vagina A DC is a digital camera connected to the colposcope with a specialized light source It will shine light on the cervix and acquire a sequence images The images will tell doctors about the cells and structure of the tissue After the first set of images acetic acid will be applied to the cervix so that lesions show up better and 1-2 minutes later more readings will be taken
Small samples of areas of abnormal tissue will be removed during colposcopy Taking these tissue samples is a routine part of this type of exam If patients are having colposcopy and loop electrosurgical excision procedure LEEP treatment one sample of normal tissue will be taken The cervix will be numbed for this procedure DCF images will be compared with lab findings from these samples Before DCF is done as standard of care patients will have a complete history and physical exam urine pregnancy test pap smear and cultures for gonorrhea chlamydia and viral testing
This is an investigational study About 114 women will take part in this study About 22 will be enrolled at M D Anderson
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