Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cervical Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/21/2018 |
| Start Date: | September 23, 2015 |
| End Date: | September 2025 |
The goal of this clinical research study is to compare a type of imaging called
high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the
standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy
procedure. Researchers also want to learn if HRME images can show the difference between
cancerous tissue and normal cervical tissue.
high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the
standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy
procedure. Researchers also want to learn if HRME images can show the difference between
cancerous tissue and normal cervical tissue.
If you are found to be eligible to take part in this study, you will first have your
scheduled VIA and colposcopy. The study doctor will tell you more about this procedure.
You will then have proflavine hemisulfate solution (contrast dye) applied to your cervix.
Images will be collected with the probe from the HRME device. The HRME probe is a long thin
tube with a camera at the tip. This should add about 10 minutes to the total procedure time.
The HRME images will be stored in an electronic database and used for research. The images
will be deidentified and only the MD Anderson staff will have access. This data will be
stored in the database indefinitely (forever).
Any abnormal areas found during the VIA and/or colposcopy will be biopsied as part of your
standard of care using very small forceps (a medical tool that is like tongs). If the exam
shows no abnormalities, a normal area will be biopsied.
The study doctor will talk to you about the results of the HRME imaging, colposcopy, and
biopsy/ies.
There will be no change to the planned standard-of-care colposcopy and biopsy.
Researchers will also collect information from your medical record about the colposcopy,
surgery, the status of the disease, and demographics (such as your age).
Follow-Up:
About 1 month after the study procedure, the study staff will contact you by phone to ask how
you are doing. The call should last about 5 minutes.
Length of Study:
Your active participation in this study will be over after the biopsy.
This is an investigational study. Proflavine hemisulfate is not FDA approved or commercially
available. The HRME device is not FDA approved or commercially available. Both are currently
being used for research purposes only.
Up to 800 participants will be enrolled in this study. Up to 400 will take part at MD
Anderson and up to 400 will take part at the Harris Health System.
scheduled VIA and colposcopy. The study doctor will tell you more about this procedure.
You will then have proflavine hemisulfate solution (contrast dye) applied to your cervix.
Images will be collected with the probe from the HRME device. The HRME probe is a long thin
tube with a camera at the tip. This should add about 10 minutes to the total procedure time.
The HRME images will be stored in an electronic database and used for research. The images
will be deidentified and only the MD Anderson staff will have access. This data will be
stored in the database indefinitely (forever).
Any abnormal areas found during the VIA and/or colposcopy will be biopsied as part of your
standard of care using very small forceps (a medical tool that is like tongs). If the exam
shows no abnormalities, a normal area will be biopsied.
The study doctor will talk to you about the results of the HRME imaging, colposcopy, and
biopsy/ies.
There will be no change to the planned standard-of-care colposcopy and biopsy.
Researchers will also collect information from your medical record about the colposcopy,
surgery, the status of the disease, and demographics (such as your age).
Follow-Up:
About 1 month after the study procedure, the study staff will contact you by phone to ask how
you are doing. The call should last about 5 minutes.
Length of Study:
Your active participation in this study will be over after the biopsy.
This is an investigational study. Proflavine hemisulfate is not FDA approved or commercially
available. The HRME device is not FDA approved or commercially available. Both are currently
being used for research purposes only.
Up to 800 participants will be enrolled in this study. Up to 400 will take part at MD
Anderson and up to 400 will take part at the Harris Health System.
Inclusion Criteria:
1. Women undergoing colposcopy for an abnormal Pap test, positive HPV test or history of
cervical dysplasia (CIN or AIS)
2. Women of childbearing potential must have a negative pregnancy test
3. Women who are at least 21 years of age or older
4. Ability to understand and the willingness to provide informed consent and sign a
written Informed Consent Document (ICD)
Exclusion Criteria:
1. Women < 21 years of age
2. Women with a known allergy to proflavine or acriflavine
3. Women who are pregnant or nursing
4. Patients unable or unwilling to provide informed consent or sign a written Informed
Consent Document (ICD)
We found this trial at
2
sites
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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