Immune System Diseases

All Conditions

Neoplasms

Nervous System Diseases

Hypersensitivity

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

The biological specimens (hereafter referred to as 'tissue') and/or images to be used in this trial must be collected from patients who are male or female and ≥ 19 years of age, and the patient is suspected to have a brain tumor and has been scheduled for neurosurgery with a potential tumor resection. There will be up to three (3) tissue sample types assessed for each participant: 1- center-of-tumor, 2- normal tissue (collected from inevitable standard resection), and 3- margin tissue. Tissues will be removed as part of the standard neurosurgical procedure. Resected tissue will be cleaned, stained, and imaged ex-vivo using cCeLL. Image recordings of sample tissue using cCeLL - Ex vivo are taken and the obtained data is stored.

Neoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo.

cCeLL - Ex vivo

Kyungmin Hwang

Heejoon Um

Sunit Das, PhD, MA, BA

Sunit Das, MD, PhD, MA, BA

Shin-Hyuk Kang, MD, M.M.Sc, PhD

The goal of this clinical trial is to determine if cCeLL imaging is as accurate as standard biopsy practices for brain tumor surgeries. The main question\[s\] it aims to answer are:

* Is it as accurate as standard biopsy practices?
* Can it be performed faster than standard biopsy practices?

Participants will consent to having their tumor tissue assessed by both cCeLL and standard biopsy procedures. There are no additional participation requirements beyond the tumor removal surgery.

The usual practice for imaging brain tumor tissue during this type of operation, is to remove tissue from a suspicious lesion and send the tissue to the pathology department where pathologists perform a test called "frozen section". The frozen section test cools the tissue to give a diagnosis of the tissue sample (e.g., cancerous or normal tissue). This process may take up to 40 minutes to perform and uses a lot of resources within the hospital. The operation can only be finished after this report is available to the surgeon. After the surgery, the tissue is assessed by pathology with a test called permanent section which can give more details about the tissue assessment. Permanent section results are not available until after the surgery is complete. VPIX Medical Inc. has developed a system to image brain tumor tissue for the purpose of making a diagnosis (clinical decision) during the operation. This system uses Confocal Laser Endomicroscopy to image the removed tissue during the operation. This may be able to replace current standard 'frozen section analysis', which would decrease the resources needed to image the tissue, and provide faster results to the surgeon during the operation. The investigators are performing this study to determine if this type of imaging is as accurate as frozen section and if it can be performed faster. The tissue samples that are being assessed by the study device will be removed as part of a participant's normal surgery. This study will compare the results of the study device and the frozen section results. During the participant's surgery, only the standard test results will be used to make decisions. The images generated by cCeLL device will also be stored in a secure server outside of Canada, for the duration of the study. These images will be de-identified to protect participant privacy, and will be used to create a scientific repository.

cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis

A Prospective, Multi-centered, Assessor-blinded Clinical Performance Study to Evaluate the Sensitivity and Specificity of the Proposed Cell/Tissue Histopathology Image Processor cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis

Agreement between cCeLL - Ex vivo and frozen section reported as the sensitivity and specificity outcomes of cCeLL Ex vivo.

Time from the beginning of imaging to the completion of analysis

Time required by the blinded assessor reach a diagnosis.

Reported as a percentage. Number of non-diagnostic images divided by the total number of images taken

Number of images required by the blinded assessor reach a diagnosis.

Unity Health Toronto

Korea University Anam Hospital

Samsung Medical Center

Seoul National University Hospital

VPIX Medical

Digestive System Diseases

Rare Diseases

Gallbladder Neoplasms

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Gallbladder Cancer

Frozen section

Evaluate the effectiveness of intra-operative frozen section in the treatment of gallbladder cancer.

The study will be looking in to identify if intraoperative frozen section is a viable method to intraoperatively evaluate the presence of adenocarcinoma and the depth of its invasion and if the information given by frozen section is enough to modify the operative strategy.

Evaluation of the Effectiveness of Intraoperative Frozen Section on the Treatment of Suspected Gallbladder Cancer

Imperial College London

Respiratory Tract (Lung and Bronchial) Diseases

Adenocarcinoma

Adenocarcinoma of Lung

Adenocarcinoma in Situ

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Carcinoma in Situ

Lung Adenocarcinoma

Sublobar resection is performed for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section

Sublobar Resection includes segmentectomy and wedge resection

Sublobar Resection

Chaoqiang Deng

Chen Haiquan, MD

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1019. The goal of this clinical trial is to confirm the therapeutic effect of sublobar resection for AIS/MIA diagnosed by intraoperative frozen section.

Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)

Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section: a Single-arm, Multi-center, Phase III Trial

The event is defined as the tumor recurrence.

The event is defined as the death due to any causes.

Fudan University

Director in the Department of Thoracic Surgery, FUSCC

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Coagulants

All Drugs and Chemicals

Tolonium Chloride

Hana'a H Algadi, Msc student

The purpose of this study is to test the accuracy of toluidine blue in the assessment of intraoperative tumor margin after excision of oral squamous cell carcinoma(OSCC)in comparison to H\&E stain on frozen section.

The incidence of oral cancer remains high, it is ranked to be the sixth most common cancer worldwide, oral squamous cell carcinoma represent more than 90% of all oral malignances.

Standard treatment for oral squamous cell carcinoma is surgical resection with free margin. Negative margin status is an important for control local recurrence and improve outcome in squamous cell carcinoma of the head and neck. Hematoxylin and Eosin (H\&E) Frozen section biopsy is useful tool for intraoperative assessment of resected margins and control of local recurrence, allowing for additional resection intraoperatively in case of positive margins. However in the least developed countries with limited resource, the frozen section is not available in a majority of centers, in addition to that if present in developed countries, it somewhat considered time and cost consumer.

Toluidine blue(TB) is metachromatic stain, easily available, economical, with high affinity for DNA and RNA. It is rapidly uptaken by malignant epithelium which contain quantitatively more nucleic acid than normal tissue. It has been widely used as screening tool for malignant and premalignant lesion.

The purpose of this study is to test the accuracy of toluidine blue in the assessment of intraoperative tumor margin after excision of oral squamous cell carcinoma(OSCC)in comparison to H\&E stain on frozen section.

Toluidine Blue Versus Frozen Sections for Assessment of Tumor Margins in Oral Squamous Cell Carcinoma

The diagnostic accuracy will be assessed by comparing the results of each technique with the final routine histopathological results.

Cairo University

principal investigator

The high-throughput extraction of large amounts of quantitative image features from medical images

radiomics

a multifactorial model combining radiomics with frozen section analysis is a potential biomarker for assessing Spread Through Air Space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas.

Spread through air space (STAS) is a novel invasive pattern of lung adenocarcinoma and is also a risk factor for recurrence and worse prognosis of lung adenocarcinoma. Its preoperative assessment could thus be useful to customize surgical treatment. Radiomics and frozen section haave been recently proposed to predict STAS in patients with lung adenocarcinoma. Radiomics-based Prediction Model is highly sensitive but not specific for STAS detection. While, frozen section is highly specific but not sensitive for STAS detection in early lung adenocarcinomas.

Therefore, the proposed project aims to develop and validate a multifactorial model combining radiomics with frozen section analysis to assesse Spread Through Air Space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas.

Radiomics Combined With Frozen Section Prediction Model for Spread Through Air Space in Lung Adenocarcinoma

Preoperative CT-based Radiomics Combined With Intraoperative Frozen Section is Predictive of Spread Through Air Space in Early Lung Adenocarcinoma

Testing the sensitivity of Radiomics to predict STAS using the area under receiver operating characteristic curve

Testing the specificity of Radiomics to predict STAS using the area under receiver operating characteristic curve

Wuhan Union Hospital, China

Symptoms and General Pathology

Mouth and Tooth Diseases

Recurrence

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

measurement of the surgical margins will be done by the surgeon in the operating room using sterile scale after resection of the primary tumor .

frozen section examination of surgical margins will be done by the pathologist.

measurement of the surgical margin by the operating surgeon using sterile scale, margins \<7mm will be revised on table

Gross examination of the resection specimen

frozen section evaluation of the specimen by the pathologist

Pankaj Chaturvedi, MS

Vidisha V Tuljapurkar, MS MCh

Deepa Nair, MS,DNB

Sudhir Nair, MS

Assem Mishra, MS,MCh

Surgical margin is a significant prognostic factor in oral cavity squamous cell carcinoma (OCSCC)\[1,2,3\]. Intra-operative frozen section (FS) has been routinely used by the surgeons to achieve adequate surgical margins. However published literature has failed to show a conclusive benefit of FS in improving oncological outcomes(4-7). The overall identification rate of the inadequate margins by FS is variable with figures in the literature ranging from25-34%.(8-10)

Revision of margins based on FS is widely practiced in centers where facility for FS is available. However this has not shown to significantly improve local control when compared to cases in which FS was not utilized , in a comparative study done at Tata memorial Hospital(TMH) (5) More-over FS is a costly procedure, and sparsely available in resource- poor countries. In a recently conducted retrospective study of 1237 patients conducted at TMH, the cost benefit ratio of FS for assessment of margin is as low as 12:1(11). In another prospective study performed at the same center , investigators found that gross examination (GE) of margins by the surgeons was as effective as FS, and achievement of gross 7mm margin all around the tumor obviated the need for FS (12). In a recent meta-analysis of 8 studies that looked at the utility of frozen section and had uniformity in frozen section analysis and definition of close margins, they concluded that revision of margins based on FS does not improve oncological outcomes and further prospective studies are needed to explore this contentious issue (13). With this background, a prospective RCT is planned to explore if gross examination by surgeon and subsequent revision of margin (if necessary) is an equally effective alternative to Frozen section based revision in a randomized controlled trial.

patient and the treating clinician will not be aware of the randomisation allocation(gross examination or frozen section) prior to resection of the tumour specimen

Gross Examinations Versus Frozen Section for Assessment of Surgical Margins in Oral Cancers

Intra-operative Gross Examination Versus Frozen Section for Achievement of Adequate Margin in Patients Undergoing Surgery for Oral Cavity Squamous Cell Carcinoma: A Randomized Controlled Trial

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

To determine the difference between the local recurrence free survival (LRFS) between intra operative gross examination by the surgeon compared with microscopic examination using frozen sections by the pathologist for the assessment of surgical margin in patients undergoing surgery for OCSCC.

Local recurrence will be defined as - tumor recurrence at the same subsite or or at margins of previous surgery \&/ reconstruction with or without nodal recurrence /distant metastases withing two years after completion of the treatment.

- Isolated regional \&/or distant metastasis without recurrence at local site will be recorded however it will not be considered as the event for measuring LRFS

To determine the accuracy of intra operative gross examination by the surgeon compared with microscopic examination of frozen sections by the pathologist for the assessment of surgical margin as compared to the final histopathology report as the gold standard.

Dr.Pankaj Chaturvedi

Dr Pankaj Chaturvedi ,Prof. and Surgeon, Dept of Head Neck Surgery

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

A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a positive surgical margin and guide secondary resection.

A prostate model was 3D printed from preoperative pelvic MRI data and used during robot-assisted radical prostatectomy to mark a positive surgical margin and guide secondary resection.

3D model guided secondary resection

Christian CE Engesser, Dr.

Jan JE Ebbing, PD Dr. med

To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.

Background:

Nerve-sparing (NS) robot-assisted radical prostatectomy (RARP) offers optimized oncological and functional outcomes and has become the preferred minimally-invasive approach when available. To maximize oncologic safety in NS-RARP, a frozen section (FS) can be used but does not provide a visual impression of the positive surgical margin (PSM) to guide secondary resection (SR).

Objective:

To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.

Design, setting and participants:

100 patients with NS-RARP performed between September 2018 and August 2021 were included in this prospective multicenter cohort study.

Interventions:

A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a PSM and guide SR.

Outcome Measurements and statistical analysis Endpoints were comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status. Secondary parameters for oncological and erectile outcomes were assessed before and one year after surgery.

Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis	NCT06098248	Benign Brain Tu... Malignant Brain...	cCeLL - Ex vivo	19 Years -	VPIX Medical
Evaluation of the Effectiveness of Intraoperative Frozen Section on the Treatment of Suspected Gallbladder Cancer	NCT06189664	Gallbladder Can...	Frozen section	-	Imperial College London
Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)	NCT06031181	Lung Adenocarci... Frozen Section Sublobar Resect...	Sublobar Resect...	18 Years - 80 Years	Fudan University
Toluidine Blue Versus Frozen Sections for Assessment of Tumor Margins in Oral Squamous Cell Carcinoma	NCT03554967	Oral Squamous C...		-	Cairo University
Radiomics Combined With Frozen Section Prediction Model for Spread Through Air Space in Lung Adenocarcinoma	NCT05400304	Lung Adenocarci...	radiomics	18 Years - 75 Years	Wuhan Union Hospital, China
Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)	NCT06031181	Lung Adenocarci... Frozen Section Sublobar Resect...	Sublobar Resect...	18 Years - 80 Years	Fudan University
Gross Examinations Versus Frozen Section for Assessment of Surgical Margins in Oral Cancers	NCT04809324	Oral Cavity Can...	Gross examinati... Frozen section	18 Years - 100 Years	Tata Memorial Centre
Radiomics Combined With Frozen Section Prediction Model for Spread Through Air Space in Lung Adenocarcinoma	NCT05400304	Lung Adenocarci...	radiomics	18 Years - 75 Years	Wuhan Union Hospital, China
Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins	NCT05960669	Prostate Cancer	3D model guided...	18 Years - 80 Years	University Hospital, Basel, Switzerland
Radiomics Combined With Frozen Section Prediction Model for Spread Through Air Space in Lung Adenocarcinoma	NCT05400304	Lung Adenocarci...	radiomics	18 Years - 75 Years	Wuhan Union Hospital, China
Toluidine Blue Versus Frozen Sections for Assessment of Tumor Margins in Oral Squamous Cell Carcinoma	NCT03554967	Oral Squamous C...		-	Cairo University

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