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

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Johan Knutsson, Assoc. Prof.

Oral cancer starts in the mucosa of the mouth and the most common site is the tongue and gingiva. One of the most important issues for the prognosis is to surgically remove all the cancer, at the sides as well as at the deep margin. To accomplish that, it is crucial to identify the border between tumour and healthy tissue. Traditionally white light from a head light or operation theatre lamp is used to illuminate the area of the tumour. Narrow Band Imaging (NBI) is an optical technique where ordinary white light is filtered so only the blue light in it is used. Illuminating the mucosa with this blue light through an endoscope with high definition image, makes the blood vessels appear more clearly. The altered blood vessels that the cancer produce can thereby be seen and mark the area where the tumour starts.

This study examines if NBI is helpful in the decision of where the border between the cancer and the normal mucosa is. If so, NBI might improve the possibility to remove all cancer tissue compared to using the ordinary white light.

This study will also increase the knowledge about the NBI technique, which is helpful in the examination of patients with suspected head and neck cancers and at the follow-up of patients after treatment.

Participants are patients with oral cancer presenting at the otorhinolaryngology department in Örebro University hospital in Sweden for surgical treatment. The surgery will be done in the usual fashion but the mucosa surrounding the tumour will also be illuminated by NBI and this picture of the vessels will be compared to the microscopic analysis by the pathologist, the so called PAD. Thereby we seek to compare the border in white light to the border seen with NBI.

Patients with primary oral cavity cancer will be examined with Narrow Band Imaging (NBI) at the time of surgery. Olympus® equipment will be used together with straight 5,9 mm endoscopes.

First the tumour border seen in white light will be defined. Thereafter endoscopic examination with white light and NBI will be performed and recorded. Then the tumour border seen in white light will be marked with dots by monopolar diathermy. Finally the area is examined again with NBI and if the tumour border is seen outside the border seen in white light, that area is marked by a suture for the pathology report.

Since the purpose of this study is to gain knowledge of NBI in oral cavity cancer, the resection margin will be marked at least 10mm from the tumour border as it is seen in white light in the ordinary fashion. However there are evolving evidence that NBI better delineate tumour border in larynx and some data for the oral cavity, therefore any suspected mucosa according to NBI outside the ordinary resection margin will be included with a small margin.

There is no uniform definition of the NBI pattern in oral cavity cancer. The planned criteria is changed IPCL type III/IV according to Takano (see ref.) and so called "marked brown dots" as criteria for precancerous or cancerous mucosa according to NBI.

The tumour border in white light and NBI will be compared and PAD is considered gold standard.

To reach 80% power with 5 % type 1 error, two-sided test, and 25% of the examinations anticipated to show different tumour border with NBI, 49 participants will be needed.

NBI in Oral Cavity Cancer

Narrow Band Imaging in Oral Cavity Cancer-defining the Tumour Border

Pseudonymised data of the NBI-picture in relation to PAD will be shared.

the possibility to determine the tumour border in the mucosa with NBI compared to white light.

Region Örebro County

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Optical coherence tomography was used to image ex vivo breast tissue specimens.

Optical coherence tomography

Lisa K Jacobs, M.D.

This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.

Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)

In this study, a patient had "positive margins" if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, "tumor on ink").

Johns Hopkins University

Diagnostic Photonics, Inc.

The investigational device only contacted excised patient tissue. The device did not contact patients as part of this study.

All Patients (Single-arm)

Specimens from all patients were evaluated by optical coherence tomography.

Optical Coherence Tomography (Single-arm)

Age, Continuous

Sex: Female, Male

47 patients completed the study. 1 patient was excluded from the analysis due to insufficient images in all specimens (did not meet protocol specifications).

Lisa K. Jacobs, M.D.

Patients with positive margins (0 mm, "tumor on ink").

Patients With All Positive Margins Correctly Identified With the Device

Patients with all negative margins (≥ 2 mm). On average, 5 out of 6 possible margins were analyzed per patient.

Number of Margins With False Positive Device Readings

Overall Study

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Near focus with narrow band imaging is used for marking the tumor margin.

After indigo carmine was sprayed over the lesion, marking is performed.

Near focus with narrow band imaging

Near-focus with narrow-band imaging is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with indio carmin spray, commonly used tool to determine tumor margin. The subject are patients who underwent endoscopic submucosal dissection for gastric neoplasms. Participants are randomized into near-focus with narrow-band imaging and indigo carmin groups. First, marking is performed at the tumor margins determined by each modality. The distance from the marking dots to the tumor margin is measured histopathologically in the resected specimens. Finally, the investigators will compare the accuracy between two groups based on the distance from marking dots to tumor margin measured by histopathologic examination.

Usefulness of Near-focus With Narrow-band Imaging

Usefulness of Near-focus With Narrow-band Imaging for Determining Gastric Tumor Margin

Marking was diagnosed as accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm

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
NBI in Oral Cavity Cancer	NCT04398121	Oral Cancer		18 Years -	Region Örebro County
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)	NCT01699867	Breast Cancer	Optical coheren...	18 Years -	Diagnostic Photonics, Inc.
Usefulness of Near-focus With Narrow-band Imaging	NCT02661945	Gastric Tumors	Near focus with...	19 Years -	Kyunghee University Medical Center
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)	NCT01699867	Breast Cancer	Optical coheren...	18 Years -	Diagnostic Photonics, Inc.
Usefulness of Near-focus With Narrow-band Imaging	NCT02661945	Gastric Tumors	Near focus with...	19 Years -	Kyunghee University Medical Center

Spots Global Cancer Trial Database for tumor margin

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