Neoplasms

All Conditions

Digestive System Diseases

Adenocarcinoma

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Patients will undergo:

* Conventional rectoscopy
* pCLE exam following injection of fluorescein, fluorescent contrast agent
* EUS : echoendoscopy
* Biopsies for histopathology : location identical to those of pCLE
* Tumor resection will be performed according to standard oncologic principles.

All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view.

Biopsies will be harvested in both healthy and tumor tissue as well.

After all procedures are complete, a second assessment of pCLE images by a third party will be performed.

Probe-based confocal laser endomicroscopy

Patients will undergo:

* Conventional rectoscopy
* pCLE exam following injection of fluorescein, fluorescent contrast agent
* EUS : echoendoscopy
* Biopsies for histopathology : location identical to those of pCLE - Tumor resection will be performed according to standard oncologic principles.

All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view.

Both healthy and tumor tissue will be examined.

Rectoscopy

Patients will undergo:

* Conventional rectoscopy
* pCLE exam following injection of fluorescein, fluorescent contrast agent
* EUS : echoendoscopy
* Biopsies for histopathology : location identical to those of pCLE - Tumor resection will be performed according to standard oncologic principles.

All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view.

Patients will undergo:

* Conventional rectoscopy
* pCLE exam following injection of fluorescein, fluorescent contrast agent
* EUS : echoendoscopy
* Biopsies for histopathology : location identical to those of pCLE
* Tumor resection will be performed according to standard oncologic principles.

All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view.

Biopsies will be harvested in both healthy and tumor tissue as well.

Biopsy and resection

Joël Leroy, Pr

This innovative study will involve the use of probe-based confocal laser endomicroscopy, a new medical imaging technology never used for surgical indications to date. Virtual biopsies (pCLE images) will be compared to histopathology analysis.

This study focuses on the evaluation of rectal tumor margins. The hypothesis is that pCLE will allow identification of rectal tumor margin, comparable to that of histopathology. In the future, decision of resection margin could rely on intraoperative pCLE exam.

The proposed study is a feasibility study, first in the indication of rectal cancer.

Defining the limits of resection of rectal tumors is often imprecise. The identification of the banks of a tumor becomes critical when it comes to the decision to potentially sacrifice the sphincter during the surgical resection. Currently tumor margins are identified by direct examination by the surgeon, or using flexible endoscopy. Endoscopy and confocal microscopy could provide precise images of tumor enabling the reliable definition of resection margins.

There would be a direct benefit for the patient, whom sphincter could be preserved. pCLE (probe-based Confocal Laser Endomicroscopy) has already been widely used for colorectal lesions, and its value proposition has been demonstrated and validated in several studies. This study is the first using pCLE intraoperatively. Study results may lead the use of pCLE to validate surgical procedure decision (resection margin) and to a revision of patient management for colorectal cancer, by adapting neoadjuvant radiochemotherapy to the patient's responder status.

The goal is to identify tumor margin (lower pole) to optimize the resection margin, and to limit resection of healthy rectal tissue for optimal anal sphincter preservation. Moreover, determining the optimal date of surgery following neoadjuvant radiochemotherapy in rectal cancer is being discussed and no consensus has been reached. Therefore, to date, there is no formal evaluation of tumor response. This is partly due to the lack of information on tumor state and tumor evolution over time, between the end of radiochemotherapy and surgery. Histological follow up of tumor would provide supporting information to fill this gap. However, frequent tumor biopsies are not possible. Alternatively, probe-based confocal laser endomicroscopy (pCLE) could allow for a sequential analysis of tumor response. Response to treatment could be assessed and used to define optimal date of surgical resection, depending on patient responding status to treatment. Responding patients would undergo surgery at a later date than non-responders, in whom surgery could be performed earlier.

Benefits of the study lay in the more accurate definition of resection margins, with its associated potential therapeutic impact of the anal sphincter preservation and in the definition of the optimal date of rectal tumor resection, based on response status to radiochemotherapy.

Study interests are :

* Microscopic structure of tumor will be analyzed at the cellular and microvascular levels and compared to healthy mucosa.
* Evolution of response during and following radiochemotherapy will be assessed, and will help classify patients as responders/non responders.
* pCLE results will be compared to histopathology results on pre-treatment and resection biopsies.
* Images gathered through the imaging modalities (WLE, pCLE, EUS) along with histopathology results will be combined to create an atlas and database of rectal tumors.

Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology

Identification of lower pole of tumor will be compared between pCLE (optical images, virtual biopsies) and conventional histopathology (biopsies, postoperative analysis of resected piece). Samples of tumor tissue and closest tissue thought to be disease-free.

Conventional biopsies and virtual biopsies prior to radiochemotherapy start (if applicable) and during surgery.

Microvascularisation density, general microstructure, image interpretation criteria, true/false positive/negative.

Will be assessed for all patients at the time of surgical procedure. Also prior to treatment for patients undergoing radiochemotherapy.

Evaluation of concordance between pCLE and conventional histopathology for :

* tissue characterization prior to and after radiochemotherapy, if applicable
* radiochemotherapy response assessment
* resection margin evaluation

For patients undergoing radiochemotherapy, 2 exams: prior to treatment start and during surgery For patients with surgery only, 1 exam: during surgery

pCLE results will be compared to EUS prior to radiochemotherapy and at the time of resection.

Creation of an image bank : identification of quality and safety criteria to be of interest for use at the time of resection

Results will be analyzed to assess whether pCLE interpretation criteria have a predictive value for identification of responder/non-responders patients to radiochemotherapy.

IHU Strasbourg

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Adenocarcinoma of Lung

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Adenocarcinoma

Open source dataset available at TCIA.org. The cohort includes CT scans of 422 patients diagnosed with NSCLC.

A cohort of patients diagnosed with NSCLC at UCSF medical center. It includes CT scans of 165 patients.

A cohort of patients diagnosed with NSCLC at Radboud medical center. It includes CT scans of 255 patients.

Open source dataset available at TCIA.org. The cohort includes CT scans of 211 patients diagnosed with NSCLC.

Radiomics -the high throughput extraction of quantitative features from medical imaging- extract features that might potentially decode biologic tumor information, which might ultimately reduce the need to use invasive procedure, such as tissue biopsy.

Virtual biopsy

Lung cancer remains the leading cause of cancer related mortality worldwide, with more than 1.5 million related deaths annually. Lung cancer is divided into two main groups: Small Cell Lung Carcinoma (SCLC) and Non-Small Cell Lung Carcinoma (NSCLC), with prevalence of \~20% and 80% respectively. NSCLC is further subdivided into adenocarcinoma (the most common), squamous cell carcinoma (SCC), and large cell carcinoma. Furthermore, each subtype is likely to have specific mutations, which could be targeted for treatment.

Medical imaging and radiomics feature extraction represent a candidate alternative to conventional tissue biopsy, a theory that is investigated in this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology	NCT01887509	Rectal Cancer Rectal Adenocar...	Probe-based con... Rectoscopy EUS Biopsy and rese...	18 Years -	IHU Strasbourg
CT-based Radiomic Signature Can Identify Adenocarcinoma Lung Tumor Histology	NCT03940846	Nonsmall Cell L...	Virtual biopsy	-	Maastricht University
CT-based Radiomic Signature Can Identify Adenocarcinoma Lung Tumor Histology	NCT03940846	Nonsmall Cell L...	Virtual biopsy	-	Maastricht University

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