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

Symptoms and General Pathology

Colonic Polyps

Polyps

Hyperplasia

Pathological Conditions, Anatomical

Intestinal Polyps

Herbal and Botanical

Cola

3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)

Proflavine Hemisulfate

Sharmila Anandasabapathy, MD

The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope device which can be used during standard endoscopy to image the gastrointestinal epithelium. Theoretically, by visualizing superficial mucosal changes at a high-resolution and magnification, the investigators will be able to obtain optical images that can be used to guide endoscopic biopsy and polypectomy. This may foster the selective targeting of dysplasia/neoplasia, thereby improving diagnostic accuracy.

Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

Anandasabapathy, Sharmila, M.D.

Infections

Immune System Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Squamous Intraepithelial Lesions of the Cervix

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

Precancerous Conditions

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Micronutrients

Coagulants

Iodine

Lugol's solution

Cadexomer iodine

5-10 ml of proflavine hemisulfate (0.01%) will be applied on the anal epithelium. The mHRME will then be inserted and imaging of abnormal tissues will be performed.

This is a single-arm study where all subjects will receive both standard of care HRA (High resolution anoscopy) and experimental mHRME imaging.

Standard of care (SOC) high-resolution anoscopy (HRA) with Lugol's iodine will be performed. The unstained (abnormal) area will be evaluated with mHRME for optical biopsy diagnosis:

1. contrast agent will be applied to anal epithelium (5-10 ml of proflavine hemisulfate (0.01%)),
2. the mHRME will then be inserted and imaging of abnormal tissues will be performed. This will add 2 to 6 minutes per procedure.

This is a single-arm study where all subjects will receive both SOC HRA and experimental mHRME imaging.

mHRME (Mobile High resolution microendoscope)

Contrast agent will be applied to anal epithelium (5-10 ml of proflavine hemisulfate (0.01%)) to use with the mHRME

Standard of care (SOC) HRA with Lugol's iodine will be performed.

High resolution anoscopy

Sharmilla Anandasabapathy, MD

Elizabeth Y Chiao, MD

The investigators have developed a portable, battery-operated, mobile high-resolution microendoscope (mHRME) that provides subcellular images of the anal epithelium, delineating the cellular and morphologic changes associated with neoplasia. The investigators' central hypothesis is that this 'optical' approach will increase the efficiency, clinical impact, and cost-effectiveness of the current standard of high-resolution anoscopy(HRA)-guided biopsy, thus facilitating usage by less-experienced clinicians in community-based or low-resource settings. To validate this, the investigators will conduct a study to determine the efficiency and diagnostic characteristics of the mHRME 'optical biopsy' approach versus the current standard of HRA-based tissue biopsy. Successful results will allow for improved efficacy and resource utilization for cancer screening in people living with HIV for anal cancer and other epithelial cancers including the cervix, oral cavity, bladder, and GI tract.

The investigators' central hypothesis is that using mHRME plus three-dimensional (3D) mapping as a diagnostic tool will improve the accuracy and efficiency of HSIL diagnoses. Additionally, the investigators hypothesize that the sensitivity (SN) specificity (SP), positive predictive value (PPV), and negative predictive value (NPV), as well as the receiver operating characteristic (ROC) curve for the identification of neoplasia on a per biopsy and per patient basis will be high. The investigators will first compare the HRA-directed biopsy (as the gold standard) to the results of the mHRME HSIL diagnosis. The SN of mHRME diagnosis in the detection of HSIL will be estimated with the binomial proportion of study participants who are positive for HSIL on HRA-guided biopsy at two thresholds of histology thresholds which are: 1) Anal intraepithelial neoplasia (AIN) 2+ threshold, and 2) AIN3+ threshold. SP will be estimated as the proportion of study participants who are negative for HSIL on HRA-guided biopsy at both thresholds. PPV and NPV will be estimated using the binomial proportion and 95% confidence interval (CI). In addition, Cohen's kappa statistic and ROC curves will be generated if patient characteristics such as low Clusters of differentiation 4 (CD4) count, combined antiretroviral treatment (cART) utilization, or high HIV viral load impact the determination of SN and SP. SN and SP of mHRME-based HSIL diagnosis will be estimated on a per lesion and per patient basis with 95% CI and compared by McNemar's test. A generalized linear model for logistic regression with multiple correlated outcomes will compare SN and SP of each method on a per biopsy and per patient basis.

Primary Objective:

To determine if the mHRME plus 3D mapping improves the accuracy of anal HSIL diagnosis compared to the gold standard of histologic diagnosis of HSIL by HRA-guided biopsy.

Secondary Objectives:

Determination whether HRME changes the decision to perform biopsy.

This is a single-arm study where all subjects will receive both standard of care HRA (High resolution anoscopy) and experimental mHRME imaging.

The Effectiveness of High Resolution Microendoscopy for People Living With HIV

The Effectiveness of High Resolution Microendoscopy (HRME) in High Grade Intraepithelial Lesions (HSIL) Diagnosis for People Living With HIV

The primary outcome of this study is to measure the operating characteristics including SN, SP, PPV and NPV comparing the physician- and algorithm- guided HRME-based image compared to the Lugol's- guided physician diagnosis of HSIL during HRA. Gold standard consensus pathology was used and pathology data needs to be obtained, verified, and entered.

Diagnostic yield: The number of neoplastic biopsies/total number of biopsies obtained in patients who received biopsies.

Total procedure time (HRA+HRME+biopsies) vs HRME time alone

Icahn School of Medicine at Mount Sinai

University of California, San Francisco

Medical University of South Carolina

Baylor College of Medicine

Professor of Medicine

Mouth and Tooth Diseases

Mouth Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa. Patients also undergo brush biopsy and incisional biopsy. Procedures are repeated every 3-4 months for 2 years.

Undergo brush biopsy and incisional biopsy

Biopsy

Fluorescence Imaging

High-Resolution Microendoscopy

Ann Gillenwater

This early phase I trial studies how well multimodal imaging works for surveillance in patients with oral potentially malignant disorders. New types of imaging devices may help doctors decide if a lesion in the mouth is pre-cancerous or cancerous.

PRIMARY OBJECTIVES:

I. To compare standard white light examination to multimodal imaging for detection of high grade dysplasia and carcinoma during follow-up examinations of patients with oral potentially malignant disorders (OPMD).

SECONDARY OBJECTIVES:

I. To determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality.

II. To compare expression of molecular biomarkers to results from white light examination, multimodal imaging and pathologic assessment in a subset of patients who have invasive biopsies or resection.

III. To compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results.

OUTLINE:

Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa. Patients also undergo brush biopsy and incisional biopsy. Procedures are repeated every 3-4 months for 2 years.

After completion of study treatment, patients are followed up at 30 days.

Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders

Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders

Will compare standard white light examination to multimodal imaging for detection of high grade dysplasia and carcinoma during follow-up examinations of patients with oral potentially malignant disorders (OPMD).

Will determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality.

Will compare expression of molecular biomarkers to results from white light examination, multimodal imaging and pathologic assessment in a subset of patients who have invasive biopsies or resection.

Will compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results.

National Cancer Institute (NCI)

Digestive System Diseases

Barrett Esophagus

Esophageal Diseases

Gastrointestinal Diseases

Confocal imaging using contrast agent fluorescein

confocal imaging using contrast agent proflavine

fluorescent contrast agent, Fluorescein 5ml

Fluorescein

3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)

Proflavine hemisulfate

Sharmila Anandasabapathy, M.D.

The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.

A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1

A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1

Proflavine hemisulfate 0.01% (derived from dissolving 10 mg Proflavine Hemisulfate USP in 100 ml of sterile water)

Sharmila Anandasabapathy

The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is a pilot study of an novel technology, a miniaturized microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This is an exploratory, not a comparative, study designed to evaluate the feasibility of using this instrument in Barrett's esophagus.

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
Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia	NCT01384240	Colon Polyps Colonic Dysplas... Anal Dysplasia	Proflavine Hemi...	18 Years -	Anandasabapathy, Sharmila, M.D.
The Effectiveness of High Resolution Microendoscopy for People Living With HIV	NCT04563754	Anal High Grade...	mHRME (Mobile H... Proflavine Hemi... High resolution...	18 Years -	Baylor College of Medicine
Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders	NCT02790853	Dysplasia Lip and Oral Ca... Oral Disorder Premalignant Le...	Biopsy Fluorescence Im... High-Resolution... Proflavine Hemi...	18 Years -	M.D. Anderson Cancer Center
Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia	NCT01384240	Colon Polyps Colonic Dysplas... Anal Dysplasia	Proflavine Hemi...	18 Years -	Anandasabapathy, Sharmila, M.D.
Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia	NCT01384240	Colon Polyps Colonic Dysplas... Anal Dysplasia	Proflavine Hemi...	18 Years -	Anandasabapathy, Sharmila, M.D.
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
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1	NCT01384695	GERD Barrett's Esoph...	Fluorescein Proflavine hemi...	18 Years -	Anandasabapathy, Sharmila, M.D.
The Effectiveness of High Resolution Microendoscopy for People Living With HIV	NCT04563754	Anal High Grade...	mHRME (Mobile H... Proflavine Hemi... High resolution...	18 Years -	Baylor College of Medicine
Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study	NCT01384227	Barrett's Esoph...	Proflavine Hemi...	18 Years -	Anandasabapathy, Sharmila, M.D.
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1	NCT01384695	GERD Barrett's Esoph...	Fluorescein Proflavine hemi...	18 Years -	Anandasabapathy, Sharmila, M.D.

Spots Global Cancer Trial Database for proflavine hemisulfate