N/A
Completed N=9
Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix
Source: ClinicalTrials.gov NCT02206048 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization
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.
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 |
— | — |
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)
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. Informational only — not medical advice.