Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Genital Neoplasms, Female

Uterine Neoplasms

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

Anti-Infective Agents

All Drugs and Chemicals

Proflavine

Anti-Infective Agents, Local

After standard colposcopy examination performed, participants undergo a high-resolution microendoscopy imaging procedure. Proflavine 0.01% is applied to the cervix, then high-resolution microendoscopy imaging procedure performed. Standard colposcopy procedure will then continue.

Proflavine 0.01% applied to the cervix before high-resolution microendoscopy imaging procedure performed.

High-resolution microendoscopy imaging procedure performed after colposcopy exam. Standard colposcopy procedure will then continue. Entire HRME imaging procedure should add less than 10 minutes to the standard colposcopy exam.

High-Resolution Microendoscopy (HRME)

Ana M Rodriguez, MD

Kathleen Schmeler, MD

The purpose of this study is to evaluate a different type of medical equipment called "High-Resolution Microendoscope" (HRME) for the diagnosis of cervical pre-cancerous lesions and cervical cancer. The investigators want to compare patients' clinical findings using the current equipment used in clinic with the clinical findings using new equipment we are testing on this research project. If the new equipment is proven to give comparable findings with current equipment being used, doctors might be able to offer a diagnosis and treat cervical lesions in one visit. It might not be necessary to wait for cervical biopsies to come back before women would receive the indicated treatment. Study subjects are being asked to participate because they have been diagnosed with an abnormal Papanicolaou (Pap) PAP smear, positive human papillomavirus (HPV) test or history of cervical dysplasia and need to have a colposcopic examination to determine the reason for abnormal results and receive treatment.

Investigators will start the participants' examination with colposcopic evaluation using current equipment as determined by standard of care. But, if cervical biopsies are indicated, before performing biopsies, for research purposes only - investigators will:

* Apply a substance called Proflavine 0.01% to participants' cervix
* Investigators will re-evaluate participants' cervix with the new equipment being tested:The High- Resolution Microendoscope
* After completing this re-evaluation, investigators will continue with the standard of care protocol and will perform participants' cervical biopsies if indicated.

The entire re-evaluation with the new equipment should add less than 10 minutes to the standard examination.

When a woman is found to have an abnormal PAP smear, depending on the findings and clinical history, most women will need to be further evaluated with a colposcope in order to understand the reason for the abnormal PAP and determine the best treatment. This is called colposcopic examination and it is the standard of care. This procedure is performed in the clinic, patient is positioned on the examining table the same way she is positioned for a Papanicolaou (Pap) smear, a speculum is placed inside the vaginal canal, and certain substances are applied to the cervix in order to identify cervical lesions. These substances might include acetic acid and/or Lugol's iodine solution. The application of these substances helps to delineate the abnormal cervical areas that might need to be biopsied. For the purpose of this research study, before obtaining the biopsies, a second evaluation will be performed using the equipment that is being studied (High- Resolution Microendoscope) and using a different substance that will be applied to the cervix. This substance is called Proflavine 0.01%. . This second evaluation should not take more than 10 minutes. After completing this second evaluation, participants' clinical examination and clinical visit should continue as routine.

The anticipated total number of subjects involved in the study will be 150 women. All these anticipated participating women would be from The University of Texas Medical Branch (UTMB), Su Clinica and UT Health Science Center (UT-HSC) Mobile Van. The length of time for participation is 1 year. However, during the participants' year of enrollment she might have only one examination, during one of her visits,using the research equipment.

Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley

Successful outcome defined as concordance between the diagnosis using HRME imaging and the most severe histologic diagnosis.

M.D. Anderson Cancer Center

The University of Texas Health Science Center, Houston

William Marsh Rice University

The University of Texas Medical Branch, Galveston

Precancerous Conditions

Antineoplastic Agents

Micronutrients

Vitamins

Acetic Acid

Retinol acetate

Vitamin A

Retinol palmitate

Anti-Bacterial Agents

Adjuvants, Immunologic

Immunologic Factors

Protective Agents

Retinol

Visual inspection of cervix performed using 3 - 5% acetic acid to the cervix. Participants undergo standard colposcopy and abnormal lesions noted by quadrant. Then 0.01% proflavine applied topically to the cervix. High-resolution microendoscopy (HRME) then performed. HRME images obtained from one visually normal site and from up to 3 visually abnormal lesions based on visual exam and/or colposcopic findings. Study staff follow up with participant by phone one month after procedure.

0.01% Proflavine applied topically to the cervix after colposcopy and HRME cervical images obtained.

HRME images obtained from one visually normal cervical site, and from up to 3 visually abnormal lesions based on exam and/or colposcopic findings.

HRME Imaging

Study staff follow up with participant by phone one month after procedure.

Phone Call

Colposcopy performed after visual inspection of cervix.

Colposcopy

3 - 5% added to cervix before visual inspection.

The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy procedure. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.

If you are found to be eligible to take part in this study, you will first have your scheduled VIA and colposcopy. The study doctor will tell you more about this procedure.

You will then have proflavine hemisulfate solution (contrast dye) applied to your 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 should add about 10 minutes to the total procedure time.

The HRME images will be stored in an electronic database and used for research. The images will be deidentified and only the MD Anderson staff will have access. This data will be stored in the database indefinitely (forever).

Any abnormal areas found during the VIA and/or colposcopy will be biopsied as part of your standard of care using very small forceps (a medical tool that is like tongs). If the exam shows no abnormalities, a normal area will be biopsied.

The study doctor will talk to you about the results of the HRME imaging, colposcopy, and biopsy/ies.

There will be no change to the planned standard-of-care colposcopy and biopsy.

Researchers will also collect information from your medical record about the colposcopy, surgery, the status of the disease, and demographics (such as your age).

Follow-Up:

About 1 month after the study procedure, the study staff will contact you by phone to ask how you are doing. The 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. Proflavine hemisulfate is not FDA approved or commercially available. The HRME device is not FDA approved or commercially available. Both are currently being used for research purposes only.

Up to 800 participants will be enrolled in this study. Up to 400 will take part at MD Anderson and up to 400 will take part at the Harris Health System.

Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia

To evaluate the performance of HRME imaging compared with existing diagnostic techniques including colposcopy and visual inspection with acetic acid (VIA), a successful outcome is defined as concordance between the diagnosis using HRME imaging and the most severe histologic diagnosis. That is, researchers will calculate the concordance with the participant as the experimental unit rather than the biopsy, as each participant may have more than 1 biopsy. Target concordance rate is 70%. Concordance rate monitored using method described by Thall et al. (1995), and trial stopped if concordance rate is less than 70%.

National Cancer Institute (NCI)

National Institutes of Health (NIH)

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Adenocarcinoma

Respiratory Tract Infections

Adenocarcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Carcinoma in Situ

Pharmaceutical Solutions

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.

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

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

High-Resolution Microendoscopy (HRME) Imaging

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.

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.

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

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

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.

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.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Due to low accrual no analysis conducted.

Dr. Kathleen M. Schmeler, MD

Due to not meeting enrollment requirements, data was not collected

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

Due to low accrual, no specimens were collected to be analyzed

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

Overall Study

Central Nervous System Depressants

Anesthetics

All patients entered in study will undergo cervical dilation after induction of general anesthesia. Once the cervix has been dilated, a hysteroscope will be introduced in the uterine cavity to evaluate for presence of tumor. Location and size of tumor documented. White-light images obtained using the High-Resolution Microendoscopy (HRME) camera introduced through the hysteroscope. Once completed; the hysteroscope will be removed and the uterine cavity will be infused with 10 mL of proflavine (an acridine dye) (0.01% Proflavine (10ml)). A resectoscope will then be introduced in the uterine cavity and fluorescent images obtained using the HRME camera. The resectoscope will then be used to remove all tumor as guided through HRME images. The entire imaging and tumor resection process is estimated to take 45 minutes or less.

Once the cervix has been dilated, a hysteroscope will be introduced in the uterine cavity to evaluate for presence of tumor. Location and size of tumor documented. White-light images obtained using the HRME camera introduced through the hysteroscope. Once completed; the hysteroscope will be removed and the uterine cavity will be infused with 10 mL of proflavine (an acridine dye) (0.01% Proflavine (10ml)). A resectoscope will then be introduced in the uterine cavity and fluorescent images obtained using the HRME camera.

High-Resolution Microendoscopy Imaging

After hysteroscopy with HRME camera, uterine cavity infused with 10 mL of Proflavine.

Pedro Ramirez, MD

The goal of this clinical research study is to learn if imaging (called a hysteroscopy) can be used to help guide tumor removal during a hysterectomy.

Tissue Collection and Imaging:

If participant is found to be eligible to take part in this study, during their standard-of-care hysterectomy, a tissue sample will be collected. This sample will be used for research and routine testing. Participant will sign a separate consent form for the hysterectomy.

During the hysterectomy, photographs of the tissue will be taken. Participant's private areas will be covered (as much as possible), and a picture of their face will not be taken.

A hysteroscopy will also be performed during participant's surgery. Participant's doctor will discuss the risks of the hysteroscopy with participant and they will be asked to sign a separate consent form. A hysteroscopy allows the doctor to look inside the uterus to see the tissue that is going to be collected for research imaging. This procedure is done with a tool called a hysteroscope, a long thin tube with a camera and a light. The hysteroscope will be inserted though the vagina and up into the uterus. An image will be displayed on a computer screen that is attached to the hysteroscope. The study doctor will use the image on the screen to look at different areas of the uterus to find the location and size of the tumor(s). This image may be recorded for future reference.

After the hysteroscopy, the study doctor will inject a contrast dye (Proflavine Hemisulfate) into participant's uterus to help the doctor see the lesions. A camera will then be used to photograph images of the uterus.

The tissue collection and the imaging will add about 45 minutes to participant's hysterectomy procedure.

Length of Study:

Patient's active participation in this study will be over after surgery.

Follow-Up Call:

About 30 days (+/-7 days) after the surgery, participant will be called and asked how they are doing.

This is an investigational study. The hysteroscope is commercially available and FDA approved for laparoscopic procedures. The use of the hysteroscope in this study is for research purposes only.

Proflavine Hemisulfate (contrast dye) is commercially available and FDA approved for treating umbilical cord stumps. Its use in this study is considered investigational.

Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.

High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection

Use of Fluorescence Imaging and High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection in Patients With Endometrial Cancer

Descriptive statistics used to summarize the expression in tumor tissue and in normal tissue for each of the molecular markers assessed, as well as the difference in tumor and normal tissue within patient. Paired t-test used to compare the tumor and normal tissue with respect to the mean difference in expression of each marker, pairing tumor and normal tissue on patient. Boxplots used to illustrate the distribution of the difference in expression in tumor and normal tissue for each marker.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley	NCT02714439	Malignant Neopl...	Proflavine High-Resolution...	21 Years - 65 Years	The University of Texas Medical Branch, Galveston
Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia	NCT02420665	Cervical Cancer	Proflavine HRME Imaging Phone Call Colposcopy Acetic Acid	21 Years -	M.D. Anderson Cancer Center
Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix	NCT02206048	Cervix Carcinom...	Proflavine High-Resolution...	21 Years - 64 Years	M.D. Anderson Cancer Center
Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley	NCT02714439	Malignant Neopl...	Proflavine High-Resolution...	21 Years - 65 Years	The University of Texas Medical Branch, Galveston
High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection	NCT02095847	Uterine Cancer	High-Resolution... Proflavine	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for hrme

Every month we try and update this database with for hrme cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hrme

Every month we try and update this database with for hrme cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hrme cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.