Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Carcinoma

Adenocarcinoma

Syndrome

Barrett Esophagus

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.

Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order.

Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete.

Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed.

After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites.

Imaging procedures (NBI)

HDWLE

pCLE

Prateek Sharma, MD

This study will collect data from patients routinely undergoing a endoscopic surveillance and Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

This is a longitudinal observational study were imaging procedures are allocated in a random order to directly address the low sensitivity and specificity of enhanced macroscopic endoscopic imaging devices by determining whether probe-based Confocal Laser Endomicroscopy (pCLE), as a supplement to Narrow Band Imaging (NBI) can further improve sensitivity and specificity to a level that would be acceptable to avoid random biopsy, and better direct biopsy of suspicious areas. The study is also addressing pCLE as a supplement to standard white light endoscopy and random biopsy alone. In fact, the study is powered to evaluate per lesion sensitivity and specificity of confocal imaging as applied to lesions identified by white light endoscopy. Therefore, the study addresses the shortcomings of standard white light endoscopy (high number of random biopsies, less than ideal directed biopsy of suspicious areas) and the primary shortcomings of Narrow Band Imaging (NBI) (low specificity with resultant high false positives, again resulting in many unnecessary biopsies).

Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.

Cellvizio Inc.

Emissary International LLC

Mauna Kea Technologies

Group 1

Age, Continuous

Sex: Female, Male

France

United States

Germany

Region of Enrollment

Christophe Bailleul

Sensitivity

Specificity

NBI (Narrow Band Imaging)

HDWLE+NBI+pCLE

HDWLE+pCLE

HDWLE+NBI

Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.

HDWLE First NBI Second and pCLE

NBI First HDWLE Second and pCLE

Overall Study

Patients subject to endocrine or digestive surgery will have intraoperative pCLE examination. The installation and surgical opening will be performed according to standard protocols. The contrast agent, fluorescein, will be injected intravenously to allow tissue visualization with pCLE. During the surgery, the surgeon will perform the pCLE examination, to obtain and record video sequences of in situ structures. Frozen sections will be obtained on the same samples and will further guide the surgical decision-making.

Histological examination by pCLE technique preceding the frozen section

IV Fluorescein (fluorescent contrast agent) administration

IV fluorescein administration

Mihaela Ignat, MD, PhD

Intraoperative histological examination is a fundamental tool in surgery. Probe-based Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time, microscope-resolution imaging, currently used in endoscopy. This pilot study aims to evaluate pCLE in surgical setting. The objective is the depiction of histological rendering of normal and pathological tissues through pCLE. Feasibility of real-time diagnosis will also be assessed. All surgical conditions usually necessitating frozen section will be investigated. A total of 30 patients, with various pathology of the thyroid / parathyroid, stomach, esophagus, pancreas, adrenal, colon / small intestine, liver will be included. Diagnostic criteria will be defined by a surgeon - pathologist team and further validated by retrospective analysis of the video sequences in comparison to conventional histology slides. The data will be used to create an image bank of reference optical biopsy images. The study will allow to point out the surgical conditions in which pCLE is the most effective and reliable and could eventually replace the frozen section technique.

Intraoperative histological examination is a fundamental tool for cancer surgery (extent of surgery, resection margins, sentinel lymph node) and necessary in other circumstances like redo surgery or endocrine surgery. Using conventional frozen section technique results in the prolongation of operating time of about 40 minutes.

Probe-based Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time, microscope-resolution imaging. Specifically, after intravenous injection of a fluorescent contrast agent - in this study fluorescein will be used, the pCLE system provides video sequences of the tissue, using a confocal microscope integrated in a miniprobe and a low power laser as the illumination source (Cellvizio®, Mauna Kea Technologies, Paris, France).

The pCLE is currently used in endoscopy, mainly for the follow-up of Barrett's esophagus, colorectal polyps and strictures of the bile and pancreatic ducts, but also in urology. The pCLE has never been tested in open or video-assisted surgery settings. Sterilizable probes exist and are certified for use via an endoscope in France (UHD CystoFlexTM, AQ-FLEX 19TM Mauna Kea Technologies, Paris, France). A probe (CelioFlex UHDTM) is currently being developed for use in laparoscopic surgery setting.

This pilot study aims to evaluate pCLE in surgical setting. Each anatomical structure corresponds to a specific tissue architecture, which is today known through standard histological examination. Conventional histology implies alteration of the tissue architecture, with ablation of blood supply, sampling and technical treatment of the samples (fixation, cutting, staining). The pCLE enables to bypass this process and allows obtaining images of the microscopic structure in vivo, without cell damage and without interruption of the blood and lymphatic circulation. The obtained video sequences reflect the microscopic architecture, in a form which is to date, neither mapped nor exploited for deep organs. The potential of this technique was demonstrated in intraabdominal organs only in the animal model, with very encouraging results as the sensitivity and specificity of pCLE were superior to standard histological examination.

The primary objective is the depiction of histological rendering of normal and pathological tissues through pCLE. Feasibility of real-time diagnosis will also be assessed. All surgical conditions usually necessitating frozen section will be investigated. A total of 30 patients, with various pathology of the thyroid / parathyroid, stomach, esophagus, pancreas, adrenal, colon / small intestine, liver will be included.

The installation and surgical opening will be performed according to standard protocols. A contrast agent, fluorescein, will be injected intravenously to allow tissue visualization with the pCLE. During the surgery, the surgeon will perform the pCLE examination, to obtain and record video sequences of in situ structures. Frozen sections will be obtained on the same samples and will further guide the surgical decision-making.

Diagnostic criteria will be defined by a surgeon - pathologist team and further validated by retrospective analysis of the sequences in comparison to conventional histology slides. The data will be used to create an image bank of reference optical biopsy images.

The study will allow to point out the surgical conditions in which pCLE is the most effective and reliable and could eventually replace the frozen section technique.

A second study, in comparative prospective settings, could further be focused only on the promising conditions in order to evaluate diagnosis accuracy on a statistical basis.

Assessment of Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery: a Pilot Study

Assessment of the Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery - a Pilot Study

The diagnosis proposed by the surgeon / investigator in intraoperative setting on the basis of video sequences of pCLE will be compared to frozen section.

The diagnosis proposed by the surgeon / investigator after retrospective review of the intraoperative video sequences of pCLE based on the newly described diagnosis criteria will be compared to frozen section and conventional histology.

Comparison of the surgeon's ability to obtain intraoperative diagnosis relative to that of the pathologist in the same circumstances.

Evaluation of the time required for the practice of pCLE and comparison to the time required for frozen section.

Morbidity rate / mortality specific to the pCLE imaging procedure.

IHU Strasbourg

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Stomach Diseases

Stomach Cancer

(Cellvisio® with confocal minoprobe™, Mauna Kea Technologies, France)

Under pCLE, target biopsy at cancer lesion will be done. 5 pieces of forcep biopsy will be obtained.

Confocal group

Random biopsy around cancer lesion will be done under WLE. 5 pieces with forcep biopsy will be obtained.

Control group

Sang Kil Lee, MD

\* single center, prospective study First, evaluate the lesion under the white light endoscopy (WLE) → IV fluorescein sodium 0.1mL/kg → evaluate the lesion under probe-based confocal laser microendoscopy → target biopsy under the pCLE → random biopsy under WLE

The purpose of this study is to conduct a study on genetic pathology, obtaining of cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples of patients after chemotherapy is usually 30% or less. Because cancer cells are often replaced with regenerative cells after chemotherapy, even though there are still remnant cancer cells in the stomach. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. In previous pilot study in our institution, pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with undifferentiated histology. However, there was no previous study about precious biopsy method for patients after chemotherapy. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for remnant gastric cancer after chemotherapy will increase the percentage of cancer cells and expression ratio of tumor marker in biopsy samples.

All procedures were performed with both WLE and pCLE. One patient underwent both WLE and pCLE. Target biopsy under pCLE and random biopsy at cancer lesion under WLE will be done for one patient. The proportion of remnant cancer cells in biopsy samples will be compared.

Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status

The percentage of remnant cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy

The specific findins of remnant cancer cells under probe-based confocal laser endomicroscopy (ex. Destruction of gland structure, increased numbers of blood vessel, dark cells...)

Yonsei University

Respiratory Tract (Lung and Bronchial) Diseases

Mesothelioma

Mesothelioma, Malignant

Malignant Mesothelioma

Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies

Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.

Study of the pleural cavity with a confocal laser endomicroscope.

Olivier Bonhomme, MD

Probe based confocal laser endomicroscopy (pCLE) is a new optical endoscopic technique, generating fluorescent light emission from the tissue of interest and allowing in vivo live imaging at a cellular level ("optical biopsies"). It was first used in gastroenterology and came later to the light in pulmonary medicine and is still an experimental technique. In gastroenterology, this new investigational technique is used in Barret oesophagus, inflammatory bowel disease, pancreas cystic lesions... Nowadays, there are no data concerning usefulness of endomicroscopy in medical thoracoscopy. During thoracoscopy This new tool could help to target biopsies or help clinicians to do the right diagnosis early, allowing rapid therapeutic intervention (talc pleurodesis for example) . Furthermore, some details can be studied only during live imaging as microorganisms or bloodflows. The investigators performed an endomicroscopy to every patient needing a thoracoscopy (no matter the indication) and who agreed to participate. The pCLE features between malignant and benign pleura were compared in order to find specific criteria for malignant infiltration.

Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.

Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table

Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.

Here are presented Mean cell size and maximum vascular diameter

Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.

Quantitative criteria are presented in this table. Here is presented the mean cellular density

Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.

Quantitative criteria are presented in this table. Here is presented the vascular density.

The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.

University of Liege

Medical doctor - clinical assistant

Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies

Study of the pleural cavity with a confocal laser endomicroscope.: Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.

Patient Aged More Than 18 Years Admitted for Thoracoscopy

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Thoracoscopy indication

Final histological diagnosis

Dr Olivier Bonhomme

The objective of the test is to assess if the pCLE feature "full chia seed sign" is found statistically more frequently in the "benign pleura group" than in the "malignant pleural infiltrations group".

The objective is to assess if the abnormal tissular architecture is significantly more frequently found in the "malignant pleural infiltrations group" than in the "benign pleura group".

The objective is to assess if the pCLE feature "cellular shape homogeneity" is found statistically more frequently in the "benign pleura group" than in the "malignant pleural infiltrations group".

The objective is to assess if dysplastic vessels are more frequently found in the "malignant pleural infiltrations group" than in the "benign pleura group".

Abnormal tissular architecture

Cellular size homogeneity

Cellular shape homogeneity

Cellular fluorescence homogeneity

Blood vessels dysplasia

Organized connective tissue

Chia seed sign

Participants with a benign pleura histological diagnosis.

Benign Pleura

Participants with a malignant pleural disease demonstrated by biopsies.

Malignant Pleural Infiltrations

Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.

Mean cell size

Maximal vascular diameter

Some criteria were not assessable for some patients.

Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.

Quality of the pCLE Acquisition

Standard high-definition white light endoscopy guided evaluation

Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)

Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy

Standard endoscopic evaluation

Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure.

pCLE guided evaluation

Michael Wallace, MD

Anne Osdoit

This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).

It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.

It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE guided evaluation (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.

CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of "Optimally Treated", in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up.

Standard high-definition white light endoscopy guided treatment

Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy

Standard Treatment

Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy

pCLE guided endoscopic treatment of BE: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure.

pCLE-guided Treatment

Standard high-definition white light endoscopy guided evaluation

Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy

Standard Endoscopic Evaluation

Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)

pCLE guided evaluation: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure.

pCLE-guided Evaluation

Total

Exploratory analysis of the data according to the intent-to-treat principle resulted in no suggestion of systematic bias in the two groups regarding withdrawals. Only 1 patient was withdrawn because of intolerance to fluorescein.

Dr Michael B. Wallace

Among the 141 patients who completed the initial procedure, 119 had follow-up visits.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy	NCT00795184	Barrett Syndrom... Barrett's Syndr... Barrett's Esoph... Barrett Esophag... Adenocarcinoma	Imaging procedu... HDWLE pCLE	18 Years -	Mauna Kea Technologies
Assessment of Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery: a Pilot Study	NCT02552004	All Surgical Co... Malignant Tumor Inflammatory Di... Benign Tumor	pCLE IV fluorescein ...	18 Years -	IHU Strasbourg
Assessment of Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery: a Pilot Study	NCT02552004	All Surgical Co... Malignant Tumor Inflammatory Di... Benign Tumor	pCLE IV fluorescein ...	18 Years -	IHU Strasbourg
Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status	NCT03449966	Advanced Gastri... Neoadjuvant Che... Palliative Chem...	Confocal group Control group	20 Years - 80 Years	Yonsei University
Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy	NCT00795184	Barrett Syndrom... Barrett's Syndr... Barrett's Esoph... Barrett Esophag... Adenocarcinoma	Imaging procedu... HDWLE pCLE	18 Years -	Mauna Kea Technologies
Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.	NCT03805971	Pleural Carcino...	Study of the pl...	18 Years -	University of Liege
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia	NCT01032044	Barrett Syndrom... Barrett's Syndr... Barrett's Esoph... Barrett Esophag... Adenocarcinoma	Standard endosc... pCLE guided eva...	18 Years -	Mauna Kea Technologies
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia	NCT01032044	Barrett Syndrom... Barrett's Syndr... Barrett's Esoph... Barrett Esophag... Adenocarcinoma	Standard endosc... pCLE guided eva...	18 Years -	Mauna Kea Technologies
Assessment of Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery: a Pilot Study	NCT02552004	All Surgical Co... Malignant Tumor Inflammatory Di... Benign Tumor	pCLE IV fluorescein ...	18 Years -	IHU Strasbourg

Spots Global Cancer Trial Database for pcle

Every month we try and update this database with for pcle 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 pcle

Every month we try and update this database with for pcle 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 pcle 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.