Clinical trial · Interventional
Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix
NCT02206048CI-TRIAL-00059855completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Carcinoma | Cervical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-Resolution Microendoscopy (HRME) Imaging | Procedure | — | UNRESOLVED |
| Proflavine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High-Resolution Microendoscopy (HRME)
- description
- 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.
- interventionNames
- Drug: Proflavine
- Procedure: High-Resolution Microendoscopy (HRME) Imaging
Primary outcomes (1)
- measure
- Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization
- timeFrame
- 1 day
- description
- Methodology determined feasible if in-vivo HRME images are acquired in if 18 of the 20 participants enrolled in the study.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.