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Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix

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ClinicalTrials.gov Identifier: NCT02206048
Recruitment Status : Active, not recruiting
First Posted : August 1, 2014
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervix Carcinoma Drug: Proflavine Procedure: High-Resolution Microendoscopy (HRME) Imaging Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix
Actual Study Start Date : October 2, 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-Resolution Microendoscopy (HRME)
Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained.
Drug: Proflavine
0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.

Procedure: High-Resolution Microendoscopy (HRME) Imaging
in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.
Other Name: HRME




Primary Outcome Measures :
  1. Feasibility of Acquiring in-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization [ Time Frame: 1 day ]
    Methodology determined feasible if in-vivo HRME images are acquired in 18 of the 20 patients enrolled in the study.


Secondary Outcome Measures :
  1. Adenocarcinoma In-Situ (AIS) Distinguished from Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging [ Time Frame: 1 day ]
    AIS finding tabulated by the CKC specimen results as determined by pathology. Concordance of HRME images taken ex-vivo estimated with pathology findings with a 90% credible, assuming a beta (1.8, 0.2) prior distribution for the concordance.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206048


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Kathleen Schmeler, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02206048     History of Changes
Other Study ID Numbers: 2013-0885
14037870 ( Other Identifier: Institution of Medicine (IOM) )
NCI-2014-01790 ( Registry Identifier: NCI CTRP )
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Cervix Carcinoma
Cervical adenocarcinoma in situ
AIS
Cervical intraepithelial neoplasia
CIN
microinvasive carcinoma of the cervix
cold knife cone of the cervix
CKC
High-Resolution Microendoscopy
HRME
Proflavine
Additional relevant MeSH terms:
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Carcinoma
Adenocarcinoma
Adenocarcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma in Situ
Proflavine
Anti-Infective Agents, Local
Anti-Infective Agents