Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Cholangiocarcinoma

Pancreatic Neoplasms

Biliary Tract Neoplasms

Constriction, Pathologic

Bile Duct Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Bile Duct Diseases

Biliary Tract Diseases

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Bile Duct Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

ERCP with or without cholangiopancreatoscopy will be performed by the endoscopist as clinically indicated. If findings at ERCP and/or prior imaging studies and/or clinical assessment suggest possible malignancy and/or an indeterminate biliary or pancreatic pathology Cellvizio probe-based endomicroscopy will be performed during ERCP.

Probe-based confocal laser endomicroscopy

Yang Chen, MD, FACP, FACG

This registry will collect data from patients routinely undergoing an ERCP and Cellvizio endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due to suspected pancreatic or bile duct cancer. 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 registry study to collect high quality longitudinal data from patients with suspected or indeterminate pancreaticobiliary pathology who are undergoing an ERCP with Cellvizio probe-based endomicroscopy procedure, with or without supplemental direct cholangiopancreatoscopy. The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP alone.

Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary and/or pancreatic duct lesions will be compared for the combination of endomicroscopy and ERCP imaging and ERCP alone. These presumptive diagnoses will be compared against a 12-month follow-up confirmed histopathologic endpoint (an initially-benign pathologic diagnosis will be confirmed by a 12-month follow-up). Secondary objectives include collecting various safety and technical performance parameters.

A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers

Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database

Cellvizio Inc.

Emissary International LLC

Mauna Kea Technologies

Anne Osdoit / Clinical Affairs Manager

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma, Pancreatic Ductal

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Mesothelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Carcinoma, Ductal

Pancreatic Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Malignant Mesothelioma

Antibodies

Immunoglobulins

Immunoglobulin G

Amatuximab (MORab-009)

Raffit Hassan, M.D.

Background:

- Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab helps the immune system to kill cells that have high levels of mesothelin. However, more research is needed to determine how safe and effective amatuximab is for treating tumors with high levels of mesothelin.

Objectives:

- To assess the safety and effectiveness of amatuximab in treating tumors with high levels of mesothelin.

Eligibility:

- Individuals at least 18 years of age who have a type of cancer that overexpresses mesothelin.

Design:

* Participants will be screened with a medical history and physical exam. They will also have blood tests and tumor assessment studies.
* Participants will have two intravenous doses of amatuximab several hours apart. Researchers will monitor them closely and do frequent blood draws. On the same day and also within 48 hours of the second dose, participants will have imaging studies. These studies will measure how well the amatuximab is working against the cancer.
* Participants will have a third imaging study of the cancer about 1 week after the infusions.
* Participants will have a followup visit 2 weeks after receiving amatuximab. This visit will require blood samples. Four weeks after receiving the drug, researchers will review patients symptoms or side effects. This interview can be done in person or by phone.

Background:

* Amatuximab is a high-affinity monoclonal IgG antibody raised against human mesothelin.
* Mesothelin is a glycosyl-phosphatidyl inositol-linked membrane glycoprotein thought to be involved in tumor metastasis
* Mesothelin is over-expressed in many cancers

Objectives:

-The primary objective is to determine the biodistribution of radiolabeled amatuximab in tumor and nontumor tissues in subjects with mesothelin over-expressing cancers including mesothelioma, pancreatic, ovarian, and non small cell lung cancer.

Eligibility:

* Female or male subjects greater than or equal to 18 years of age;
* Histologically confirmed mesothelin-expressing cancer;
* Transaminases less than or equal to 3 times ULN for mesothelioma, non small cell lung and ovarian cancer;
* Transaminases less than or equal to 5 times ULN for pancreatic cancer with known liver metastasis.

Design:

* This is a single-center, single-dose, open-label, pilot study of MORAb-009 in approximately 20 subjects with mesothelin expressing tumors.
* Indium-radiolabeled MORAb-009 (5mCi) will be administered.
* Serial single photon emission-computerized tomography imaging will be performed to determine binding to tumor and nontumor tissue.
* Subjects will be observed closely for safety and possible development of anti-MORAb-009 antibodies.
* Pharmacokinetics of radiolabeled antibody will be determined with imaging over time.

Amatuximab for High Mesothelin Cancers

A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers	NCT00779688	Pancreatic Canc... Bile Duct Cance...	Probe-based con...	18 Years -	Mauna Kea Technologies
Amatuximab for High Mesothelin Cancers	NCT01413451	Carcinoma, Panc... Mesothelioma Ovarian Neoplas... Carcinoma, Non-...	Amatuximab (MOR...	18 Years - 100 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for pancreatic duct cancer