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

NCT02206048 | Completed Results FDA Drug

• 3 other identifiers: 2013-088514037870NCI-2014-01790
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervix Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization

  Methodology determined feasible if in-vivo HRME images are acquired in if 18 of the 20 participants enrolled in the study.

  1 day

Secondary Outcomes (1)

• Adenocarcinoma In-Situ (AIS) Distinguished From Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging

  1 day

Study Arms (1)

High-Resolution Microendoscopy (HRME)

EXPERIMENTAL

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; Procedure: High-Resolution Microendoscopy (HRME) Imaging

Interventions

Proflavine DRUG

0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.

High-Resolution Microendoscopy (HRME)

High-Resolution Microendoscopy (HRME) Imaging PROCEDURE

in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.

Also known as: HRME

High-Resolution Microendoscopy (HRME)

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Any woman with a confirmed preoperative diagnosis of cervical AIS, including co-existing squamous CIN and/or microinvasive cancer
• Women undergoing cold knife cone (CKC) of the cervix at MD Anderson
• Negative pregnancy test for women of child-bearing potential
• Women who are \>/= 21 years of age and \< 65 years of age
• Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD)

You may not qualify if:

• Women \< 21 years of age and \>/= 65 years of age
• Women with a known allergy to proflavine or acriflavine
• Women who are pregnant or nursing
• Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Interventions

Proflavine; X-Rays

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Limitations and Caveats

Due to low accrual no analysis conducted.

Results Point of Contact

• Title: Dr. Kathleen M. Schmeler, MD
• Organization: UT MD Anderson Cancer Center

kschmele@mdanderson.org

713-745-3518

Study Officials

• Kathleen Schmeler, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: August 1, 2014
• Study Start: October 2, 2015
• Primary Completion: April 21, 2021
• Study Completion: April 21, 2021
• Last Updated: July 25, 2022
• Results First Posted: July 25, 2022

Record last verified: 2022-07

Locations

US (1)