N/A N=9 Diagnostic

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

Cervix Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT02206048 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2022

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

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Proflavine (Drug); High-Resolution Microendoscopy (HRME) Imaging (Procedure)
Age: Adult · 21+ yrs
Sex: Female
Sponsor: M.D. Anderson Cancer Center
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization	—	—
SECONDARY Adenocarcinoma In-Situ (AIS) Distinguished From Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging	—	—

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.

Eligibility Criteria

Inclusion Criteria

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
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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02206048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.