Cervix Carcinoma
Conditions
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
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.
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.
Interventions
DRUGProflavine
0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.
PROCEDUREHigh-Resolution Microendoscopy (HRME) Imaging
in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 64 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization | 1 day | Methodology determined feasible if in-vivo HRME images are acquired in if 18 of the 20 participants enrolled in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adenocarcinoma In-Situ (AIS) Distinguished From Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Proflavine: 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.
High-Resolution Microendoscopy (HRME) Imaging: in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Change in OR schedule and availability of study staff | 1 |
Baseline characteristics
| Characteristic | High-Resolution Microendoscopy (HRME) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
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.
Time frame: 1 day
Population: Due to not meeting enrollment requirements, data was not collected
Secondary
Adenocarcinoma In-Situ (AIS) Distinguished From Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging
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.
Time frame: 1 day
Population: Due to low accrual, no specimens were collected to be analyzed