Neoplasms

All Conditions

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

All Drugs and Chemicals

Cola

The capsule endoscopy will be ingested by the participant. This device captures images along the large bowel. This images are stored in an external memory and afterwards they are downloaded in a computer

Colon Capsule Endoscopy

Antonio Z Gimeno García, MD, PhD

Antonio Z Gimeno Garcia, MD, PhD

The main purpose of the study is to determine risk factors of poor bowel cleansing in patients referred for colon capsule endoscopy (CCE) examination. Patients will be prepared with polyethylene glycol (PEG), and a booster by using oral low volume sodium phosphate (NaP) and sodium-amidotrizoate and meglumine-amidotrizoate (Gastrografin ®) The investigators also will try to design a predictive score of poor bowel cleansing and to validate the Bowel cleansing score designed by Leighton and modified by Spada

As in conventional colonoscopy, colon cleansing is essential to achieve a quality examination through the colon capsule endoscopy. The CCE also presents additional difficulties due to the inability to distend the walls of the colon, aspirate liquid and debris and wash. These reasons make that the colonic preparation should be even more effective when the exploration is going to be performed by CCE than with the conventional colonoscopy. Using a combination of PEG, sodium phosphate and bysacodil suppository achieves at least 80% of well-prepared CCE. The rate of CCE with inadequate preparation according to different studies ranges from 12% to 34% . It has recently been suggested that the addition of a water-soluble contrast agent such as Gastrografin® commonly used in different radiological tests could improve cleaning.

Although, predictive factors of poor bowel cleansing in outpatient conventional colonoscopy are well-known, currently, there are no studies that evaluate the independent predictive factors of poor colonic preparation in patients who undergo a CCE. The investigation of the predictive factors of poor colonic preparation in these patients, following the current recommendations can be of great interest to identify those patients with greater difficulties in obtaining an acceptable cleaning quality.

The researchers will offer to participate in the study to patients scheduled for CCE who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information on the diet and the bowel cleansing solution to be taken. The bowel cleansing quality following Spada Bowel Preparation Scale will be assessed by the endoscopist The aim of this study is to figure out the risk factors of bowel cleansing of inadequate bowel preparation in patients referred for colon capsule endoscopy.

A maximum of 8 variables in the multivariate analysis will be included. Considering a percentage of poor preparation of 20%, the inclusion of 350 patients will be necessary. A maximum of 15% of losses will be considered, so the final sample size will be 403 patients.

A univariate and multivariate analysis will be carried out to determine those factors associated with a lack of progression from capsule to rectum and accelerated progression. For the first of these objectives, well prepared colonoscopies but in which the rectum was not identified (identification of the hemorrhoidal plexus) will be excluded.

Predictors of Poor Bowel Cleansing and Capsule Endoscopy (CEPREDICT)

Risk Factors of Inadequate Bowel Cleansing in Colon Capsule Endoscopy

Quality of bowel cleansing assessed by the Spada Bowel Preparation Scale. Cleansing is classified from 1 ( no preparation) to 4 (excellent preparation) in each of the 4 segments of the colon (proximal colon, transverse colon, distal colon and rectum)

Hospital Universitario de Canarias

Digestive System Diseases

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.

Intervention: 'Tethered Capsule Endomicroscopy (TCE) Imaging of Barrett's esophagus using OFDI capsule

Tethered Capsule Endomicroscopy will be used to detect Barrett's Esophagus

Tethered Capsule Endomicroscopy (TCE)

Guillermo Tearney, MD, PhD

The goal of this research is to follow Barrett's Esophagus patients for 3 years using the tethered capsule endomicroscopy device with distal scanning and a compact imaging system in a multi-site clinical study.

The progression of Barrett's Esophagus will be studied over time using tethered capsule endomicroscopy imaging and will be performed at 5 different clinical centers in the US, namely: Massachusetts General Hospital (MGH),(MA), Mayo Clinic Jacksonville (FL), Mayo Clinic Rochester (MN), Columbia University Medical Center (NY), Kansas City VA Medical Center (MO). MGH will be the coordinating center of this multicenter study. Dr G. Tearney will serve as study Sponsor Investigator.

The purpose of this study is to determine the natural history of Barrett's Esophagus using TCE in subjects diagnosed with Barrett's Esophagus and undergoing surveillance endoscopy.

A hundred patients are enrolled in year 1 in each of five participating centers.

Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

We will be measuring the size of the area affected by Barrett's. The measurements will done in cm.

Columbia University

Mayo Clinic

Kansas City Veteran Affairs Medical Center

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Massachusetts General Hospital

Professor of Pathology, HMS

Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.

Imaging of Barrett's esophagus (BE) using OFDI capsule imaging

OFDI capsule imaging

The goal of this research is to determine the natural history of Barrett's esophagus (BE) using tethered capsule endomicroscopy (TCE) in patients undergoing surveillance endoscopy.

The MGH will be the first site in the multi-center study to begin enrolling. At the MGH 100 subjects with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled.

Each subject will undergo a minimum of 2 esophagogastroduodenoscopies (EGD), one around the time of inclusion into the study and one at the end of the study, and 4 TCE imaging sessions (baseline, 1-year, 2-years and at the end of the 3-years follow-up). If it is determined by the treating physician that additional EGDs are needed, for extended follow-up or treatment, capsule imaging will be performed whenever possible.

Patients will have received written information prior to the day of the capsule procedure and patients will have another chance to discuss the procedure with the study coordinator and clinical study staff during the consent process prior to the capsule procedure. Participation in this study is completely voluntary, and the patient can stop the procedure at any time.

For each of the imaged patients, inclusion criteria and clinical characteristics such as age, sex, body mass index (BMI), current medication regimen, smoking history and GI related history will be recorded in the clinical form.

Subjects will be seated and asked to sip water to facilitate swallowing the capsule.

The device will be operated by experienced study staff trained in the procedure such as a registered nurse or one of the endoscopist co-investigators in this study. Emergency phone and/or pager contact of the collaborating GI clinician(s) will be provided. They will also be accessible during the procedure if any problems are encountered that require their expertise.

Imaging will be performed in the same manner as in our other current IRB approved tethered capsule endomicroscopy studies. The capsule position will be controlled manually via the tether outside of the subject's mouth by the catheter operator. Recorded real-time cross-sectional images displayed on the monitor and distance marks on the tether will be used for confirmation of capsule position in the esophagus. Images will be viewed in real time to determine when the capsule has reached the stomach. The resistance of the tether can also give information of the cardia position. Once in the stomach, the capsule will be gradually pulled back up through the esophagus to the mouth, also while imaging. The capsule may be repositioned for imaging up to 4 times up and 4 times down the esophagus. The subject may be asked to swallow a different size capsule (ranging from 5-12.8 mm in diameter and 20-30 cm in length) to obtain the best distal esophageal images. It is expected that the maximum experimental time including swallowing the capsule, the imaging procedure, and removal of the capsule will take approximately 10 minutes in total.

Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. They will assess how the images change over time.

Principal Investigator - MD, PhD, FACC, FCAP, FNAI

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Esophagitis

Eosinophilic Esophagitis

Gastroenteritis

Eosinophilia

Leukocyte Disorders

Hematologic Diseases

Hypersensitivity

Hypersensitivity, Immediate

Eosinophilic Gastroenteritis

Subject will swallow the SECM capsule and the imaging of the esophagus will be performed using a SECM optical system

Subjects will swallow a SECM capsule and the SECM imaging will be performed

SECM capsule

Anita Chung, RN

Nitasha Bhat, MD

Elizabeth Biddle, RN

The goal of this validation study is to compare Spectrally Encoded Confocal Microscopy (SECM) Tethered Capsule Endoscopy (TCE) diagnosis of Eosinophilic Esophagitis to that of standard of care endoscopic biopsy.

Eosinophilic esophagitis is an inflammatory condition of the esophagus that occurs in response to certain foods or allergens. Approximately 300,000 people in the US have EoE, the incidence of newly diagnosed EoE is \~30,000/year, and EoE is found in 5-10% of all patients undergoing upper endoscopy. EoE is associated with debilitating symptoms, and is a common cause of dysphagia, strictures, and food impaction; it may even lead to esophageal perforation. Because of the impact of EoE on quality of life as well as the concern that this disease may progress to esophageal fibrosis with unknown long-term risks, experts recommend that EoE be treated until symptoms and eosinophilic infiltrate are resolved. Because the only objective method for diagnosing EoE is histopathologic assessment of multiple upper endoscopic biopsies, the processes of monitoring the esophagus during therapy and the food reintroduction involve a high number of repeat endoscopies. This process is both time consuming and frustrating for patients and their families. Because the endoscopic biopsy requires conscious sedation, it is also costly, exceeding $1000 per procedure. Given the rapid increase in the number of patients with this disease, there is a compelling need for a less invasive and more cost-effective means of identifying eosinophils in the esophagus.

Based on the extensive experience with Optical Coherence Tomography (OCT) and OFDI, the investigators at Tearney laboratory at MGH have developed a spectrally encoded confocal microscopy (SECM) technology that is able to acquire images at significantly higher frame rates than standard confocal microscopy. This SECM capability enables imaging of large portions of the esophagus at 2-µm resolution in realistic procedure times. Furthermore, the investigators at Tearney laboratory have created a tethered capsule SECM device that can be swallowed and used for EoE screening. The investigators at Tearney laboratory lab performed a pilot study using a SECM capsule on 58 subjects (2013-P-000863). The imaging was successful with no adverse or unanticipated events. SECM endoscopy capsule is similar to the approved endoscopy capsule.

A total of sixty (60) subjects will be recruited for this study. The imaging of the esophagus will be obtained. Subjects will not be sedated for the procedure.

The images obtained by the SECM capsule will be compared to the images obtained by the clinical endoscopy and biopsy. SECM imaging will be used for research purposes only and will not be used for diagnosis purposes.

Imaging of the Esophagus Using a SECM Capsule

comparing SECM imaging of the esophagus obtained with a SECM capsule to histopathology.

Principal Investigator

Carcinoma

Adenocarcinoma, Clear Cell

Adenomyoepithelioma

Adenocarcinoma

Epithelial-myoepithelial Carcinoma

ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday.

ENMD-2076

Amit Oza, M.D.

This is a phase 2 study to see how useful, safe, and tolerable an investigational drug called ENMD-2076 is in treating patients with ovarian clear cell carcinomas.

ENMD-2076 is an oral drug that works by blocking certain enzymes called Aurora A and tyrosine kinase from working. These enzymes are needed for cells to divide including cancer cells. ENMD-2076 also works by stopping the growth of new blood vessels which would provide the tumor with nutrients for it to grow. It is believed that by blocking Aurora A and tyrosine kinase enzymes from working and stopping new blood vessels from growing, the tumors may stop growing or shrink.

During the study, participants will be asked to take ENMD-2076 once a day, everyday. Every 28 days will be called a cycle. While receiving the study drug, participants will be asked to visit the clinic for tests and procedures. During Cycle 1, participants will be asked to visit the clinic about once a week and during Cycle 2 and future cycles, participants will be asked to visit the clinic on days 1 and 15. As a part of the study, tumor tissue (archival and fresh tumor biopsy) will be taken for biomarker research. When participants stop the study drug, they will be asked to have an end of study drug visit.

A Study of ENMD-2076 in Ovarian Clear Cell Cancers

Phase II Study of Oral ENMD-2076 Administered to Patients With Ovarian Clear Cell Carcinomas

Progression Free Survival (PFS) is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause or last follow up. PFS will be censored for patients who are alive and free of progression at time of last follow-up.

Percentage of patients with complete or partial response as per RECIST 1.1 criteria.

Length of time until disease progression in patients treated with ENMD-2076

Association of somatic mutations in PIK3CA, ARID1A and PTEN mutation status, and ARID1A and PTEN expression assessed in archival samples and tumour biopsies with tumour response and patient outcome following treatment with ENMD 2076.

University Health Network, Toronto

ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients will continue on therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface area under 1.65m2) are permitted, along with up to two weeks of therapy interruption for recovery from toxicity or intercurrent illness.

ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday for 28 day cycles. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday for 28 day cycles. Patients can continue on therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface under 1.65m2) are permitted, with up to two weeks of therapy interruptions permitted for recovery from toxicity or intercurrent illness.

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Prior Therapy

Of the 40 participants accrued onto trial, 38 were evaluable. Two participants did not complete therapy, and were deemed unevaluable

Dr. Amit Oza

Of the 40 participants enrolled, 38 were deemed eligible for evaluation. Two patients did not complete one cycle of therapy and were considered not evaluable.

Six Month Progression Free Survival Rate

ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients will continue therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface area under 1.65m2) are permitted, along with up to two weeks of interrupted therapy for recovery from toxicities or intercurrent illness.

Of the 40 participants enrolled onto trial, 38 were deemed eligible for evaluation. 2 patients did not complete a cycle of therapy and were considered ineligible for evaluation.

Complete or Partial Response Rate

Time to Disease Progression

Levels of Certain Proteins and Gene Expression Compared to Patient Outcome Following Treatment

ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday, for the 28-day cycles. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients continue treatment until disease progression or unacceptable toxicity. Two dose reductions, 225mg and 150mg, are allowed (200mg and 150mg for patients with a body surface area under 1.65m2) and interruptions of therapy up to two weeks are permitted for recovery from toxicity or intercurrent illness.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Predictors of Poor Bowel Cleansing and Capsule Endoscopy (CEPREDICT)	NCT03933371	Colon Adenoma	Colon Capsule E...	18 Years -	Hospital Universitario de Canarias
Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy	NCT03459339	Barrett Esophag...	Tethered Capsul...	18 Years -	Massachusetts General Hospital
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy	NCT02994693	Barrett Esophag... Barretts Esopha...	OFDI capsule im...	18 Years -	Massachusetts General Hospital
Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy	NCT03459339	Barrett Esophag...	Tethered Capsul...	18 Years -	Massachusetts General Hospital
Predictors of Poor Bowel Cleansing and Capsule Endoscopy (CEPREDICT)	NCT03933371	Colon Adenoma	Colon Capsule E...	18 Years -	Hospital Universitario de Canarias
Imaging of the Esophagus Using a SECM Capsule	NCT03546660	Eosinophilic Es... Barrett Esophag...	SECM capsule	12 Years -	Massachusetts General Hospital
A Study of ENMD-2076 in Ovarian Clear Cell Cancers	NCT01914510	Ovarian Clear C...	ENMD-2076	18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for capsule

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

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