Neoplasms

Mouth and Tooth Diseases

All Conditions

Rare Diseases

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Anti-Infective Agents

All Drugs and Chemicals

Central Nervous System Depressants

Proflavine

Anesthetics

Anti-Infective Agents, Local

Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (HRME) at baseline, after induction of general anesthesia, and prior to surgery.

Undergo evaluation of oral lesions using a high-resolution microendoscope

High-Resolution Microendoscopy

Undergo evaluation of oral cavity using a widefield multispectral imaging

Multispectral Imaging

Proflavine) used to stain the mouth tissue after initial imaging.

Ann Gillenwater

Ann M. Gillenwater

This clinical trial studies wide-field and high resolution in vivo imaging in visualizing lesions in patients with abnormal or uncontrolled oral cell growth (neoplasia) undergoing surgery. Diagnostic procedures, such as wide-field and high resolution in vivo imaging, are devices that let researchers look at a wide area of the lining of the mouth by shining different colors inside the mouth and taking pictures and this may help doctors to decide if a mouth lesion has a high risk of being pre-cancerous or cancerous.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility for assessing oral mucosa in vivo with wide-field and high resolution images obtained using new optical imaging devices composed of cameras and microscopes, and with a topically administered contrast agent.

II. To develop and evaluate algorithms to classify tissue as normal (including hyperkeratosis, hyperplasia, and inflammation) or abnormal (any grade of dysplasia or cancer) based on quantitative parameters extracted from the optical images.

SECONDARY OBJECTIVES:

I. To determine the percentage of subjects and lesions that can be successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye.

II. To identify qualitative and quantitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions.

OUTLINE:

Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (high-resolution microendoscope \[HRME\]) at baseline, after induction of general anesthesia, and prior to surgery.

After completion of study, patients are followed up for 3 months.

Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery

Wide-Field and High Resolution In Vivo Imaging of Oral Neoplasia Using Topical Fluorescent Dyes: A Feasibility Study

Images obtained will be compared against the histology slides of tissue taken from the same region.

Classification algorithms will be developed to separate imaged tissue into 2 diagnostic categories: normal non-neoplastic mucosa vs. dysplasia and cancer

The data analysis will be descriptive and exploratory in nature. The potential association between sites within the same subject will be examined as well. Performance will be characterized in terms of sensitivity, specificity, area under the ROC curve, and classification accuracy within each diagnostic category.

Performance will be characterized in terms of sensitivity, specificity, area under the ROC curve, and classification accuracy within each diagnostic category.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Tc-ICG in the prostate (SN procedure) and fluorescein unlilateral in leg or abdominal wall

Sentinel node biopsy with Indocyanine Green -Technetium - Nanocolloid + fluorescein

multispectral imaging

Indocyanine green injected in abdominal wall

fluorescence for lymphatic mapping

Henk van der Poel, Prof. MD

Fijs van Leeuwen, Prof

Henk Van der Poel

Multispectral imaging of the lymphatic draining pattern of the tumor and the abdominall wall/lower limb to evaluate technical feasibility to differentiate these patterns and in the future reduce the amount of complications that result from damage to lymphatic structures.

By preventing unnecessary resection of healthy lymphatic tissue during extended lymph node dissections, the investigators will be able to reduce the degree and amount of complications that result from damage to the lymphatic structures. The investigators aim to evaluate the technical feasibility of imaging two different lymphatic drainage profiles, namely that of healthy tissue (i.e. the lower limbs/abdominal wall) and that of the primary tumour (i.e. prostate). To realize the differentiation, real-time multispectral fluorescence imaging of two spectrally different tracers (the lymphangiographic tracer fluorescein (injected in the lower limbs and abdominal wall) and sentinel node (SN) specific tracer Indocyanine Green (ICG)-99mTc-nanocolloid (injected in the tumour, followed by a control lymphoscintigraphy and SPECT/CT)) will allow for multispectral (or multicolor) fluorescence. Complementary to the routine surgical procedure, e.g. radical prostatectomy with extended pelvic lymph node dissection (ePLND), the lymphatic drainage pattern of both the tumour and of healthy tissue, i.e. lower limbs and abdominal wall, will be determined in the surgical field/surgical specimens.

Multispectral Fluorescence as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies in Prostate Cancer.

MultiSPectral fLuorescence Imaging as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies During Lymph Node Dissections in Prostate Cancer.

The ability to visually differentiate the draining lymphatics of the lower limbs and abdominal wall, (LNLower limb/abdominal wall; fluorescein) from the disease associated LNs (LNprostate cancer; ICG-99mTc-nanocolloid) during lymph node dissection

Determine the anatomical relationship between lymphatic tumour spread and the lymphatic drainage profiles of the lower limbs and primary tumour (i.e. prostate) in relation to ePLND template.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery	NCT01269190	Oral Cavity Neo...	High-Resolution... Multispectral I... Proflavine	18 Years -	M.D. Anderson Cancer Center
Multispectral Fluorescence as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies in Prostate Cancer.	NCT05120973	Prostate Cancer	multispectral i... fluorescence fo...	18 Years -	The Netherlands Cancer Institute
Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery	NCT01269190	Oral Cavity Neo...	High-Resolution... Multispectral I... Proflavine	18 Years -	M.D. Anderson Cancer Center

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