Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix
Status: | Active, not recruiting |
---|---|
Conditions: | Cervical Cancer, Women's Studies |
Therapuetic Areas: | Oncology, Reproductive |
Healthy: | No |
Age Range: | 21 - 64 |
Updated: | 10/11/2018 |
Start Date: | October 2, 2015 |
End Date: | October 2019 |
The goal of this clinical research study is to learn if it is possible to get high-resolution
microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right
before a biopsy of the cervix. Researchers also want to learn if HRME images can show the
difference between cancerous tissue and normal cervical tissue.
microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right
before a biopsy of the cervix. Researchers also want to learn if HRME images can show the
difference between cancerous tissue and normal cervical tissue.
If you agree to take part in this study, after you are in the operating room and under
general anesthesia, proflavine hemisulfate solution (contrast dye) will be applied to the
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 probe will be applied to the cervix and images
obtained. These images will be used for research. This should add about 10 minutes to the
total time you are in the operating room.
There will be no change to the planned standard-of-care colposcopy and biopsy.
Follow-Up:
A member of the research team will call you within 30 days after the procedure to ask how you
are feeling and if you are having any symptoms. This 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. The goal of this clinical research study is to learn if it
is possible to get high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue
from microinvasive carcinoma right before a biopsy of the cervix. Researchers also want to
learn if HRME images can show the difference between cancerous tissue and normal cervical
tissue.
general anesthesia, proflavine hemisulfate solution (contrast dye) will be applied to the
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 probe will be applied to the cervix and images
obtained. These images will be used for research. This should add about 10 minutes to the
total time you are in the operating room.
There will be no change to the planned standard-of-care colposcopy and biopsy.
Follow-Up:
A member of the research team will call you within 30 days after the procedure to ask how you
are feeling and if you are having any symptoms. This 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. The goal of this clinical research study is to learn if it
is possible to get high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue
from microinvasive carcinoma right before a biopsy of the cervix. Researchers also want to
learn if HRME images can show the difference between cancerous tissue and normal cervical
tissue.
Inclusion Criteria:
1. Any woman with a confirmed preoperative diagnosis of cervical AIS, including
co-existing squamous CIN and/or microinvasive cancer
2. Women undergoing cold knife cone (CKC) of the cervix at MD Anderson
3. Negative pregnancy test for women of child-bearing potential
4. Women who are >/= 21 years of age and < 65 years of age
5. 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 and >/= 65 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
1
site
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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