CONTACT: Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas

Sponsor

Mauna Kea Technologies (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01563133

Collaborator

(none)

330

Enrollment

Locations

Arm

Duration (Months)

110

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses.

On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses and Lymph nodes are less developed.

The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes.

Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making.

For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by :

Ruling out malignancy for patients with benign appearing nCLE images.
Characterizing more malignant tumors in the pancreas.

Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during EUS-FNA procedures is feasible and that descriptive criteria can be defined to further differentiate the different types of lesions.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cyst Pancreatic Neoplasms Pancreatic Adenoma Pancreatic Cancer Pancreatic Islet Cell Tumors Lymph Node Lymphadenopathy	Procedure: EUS-FNA Device: nCLE	N/A

Detailed Description

Medical background Pancreatic cancer is the fourth leading cause of cancer-related death in the United States. This disease is associated with a high mortality rate: the 5-year survival rate is estimated to be 4%. This is mainly due to the fact that the disease is often discovered at an already advanced disease state, which carries a dismal prognosis.

1.1. Pancreatic Cysts

Pancreatic cysts are quite rare, but are being increasingly recognized due to the expanding use of cross-sectional imaging. They are classified into three main classes:

Pseudocysts
Serous cysts : either serous cystic neoplasms (SCN) or Solid pseudo-papillary neoplasm (SPN)
Mucinous cystic neoplasms : either Intraductal Papillary Mucinous Neoplasm (IPMN) or mucinous cystadenomas/mucinous cystadenocarcinoma(MCN) Mucinous cystic neoplasms are considered to be malignant or pre-malignant and are considered for surgical resection, whereas pseudocysts and serous cysts are considered benign and with a low potential for malignancy. Pseudocysts and serous cysts are usually only considered for surgical resection when symptomatic or enlarging.

1.2. Pancreatic masses Pancreatic solid masses can be either exocrine or endocrine tumors, or metastatic.Exocrine tumors are by far the most common type of pancreas cancer. Most of them are malignant. About 96% of cancers of the exocrine pancreas are adenocarcinomas, which is the most aggressive form of pancreas cancer.Endocrine tumors are uncommon. They represent 4% of pancreas tumors. They are known as neuroendocrine tumors (NETs), or islet cell tumors. These tumors can be benign or malignant.

1.3. Lymph nodes Lymph nodes are examined in a patient with a suspicion of, or confirmed, cancer, as part of the staging. They may be either normal, inflammatory, or malignant.

Clinical background

2.1. EUSFNA Endoscopic Ultrasound (EUS) is the diagnostic method of choice when a pancreatic lesion is found incidentally on cross-sectional imaging. Endoscopic UltraSound-guided Fine Needle Aspiration (EUS FNA) (respectively Endobronchial Ultrasound-guided Fine Needle Aspiration (EBUS FNA)) are procedures where a target tissue in proximity to the GI tract (respectively the pulmonary tract) is biopsied using a fine needle guided in real time by an ultrasound probe fixed at the tip of an endoscope.It may therefore be applied to pancreatic lesions, or lymph nodes examination.

2.2. nCLE The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image organs within or adjacent to the GI or respiratory tracts with a miniprobe inserted through an endoscopic needle. The fundamental technology as well as the principle of operation of nCLE are substantially similar to pCLE.

Clinical evidence More than 100 patients have already underwent an nCLE procedure, in the past studies. A first feasibility study enabled to define the final type of probe which would fit into a EUSFNA needle, and the INSPECT study enabled to define interpretation criteria on the micro-structure of pancreatic cysts. Less data is available on pancreatic masses and lymph nodes, except for a few images done in the first feasibility study.
Objectives

4.1. Cysts 4.1.1. The primary objective of the study is to assess the diagnostic performance of the Cellvizio nCLE system in diagnosing pancreatic cysts, when associated with other diagnostic information.

4.1.2. The secondary objectives are to assess the potential impact of the Cellvizio nCLE system on patient management and validate the interpretation classification criteria that were created during the previous INSPECT study on cysts.

4.2. Pancreatic masses and Lymph nodes 4.2.1. The primary objective of the study is to define criteria of nCLE sequences in lymph nodes and pancreatic masses.

4.2.2. The secondary objectives are to evaluate feasibility and safety of the Cellvizio nCLE during EUS-FNA procedures, build an atlas of images of nCLE sequences of pancreatic masses and lymph nodes, and, finally, retrospectively assess the diagnostic performance of nCLE in the diagnosis of pancreatic masses and lymph nodes, when associated with other diagnostic information

Design This study will be conducted in three centers in France.

Study Design

Study Type:

Interventional

Actual Enrollment :

330 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Clinical Evaluation Of NCLE in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Mar 2, 2016

Anticipated Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Lymph nodes, pancreatic masses & cysts	Procedure: EUS-FNA Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle Other Names: ultrasonographic endoscopy EUS-guided FNA Device: nCLE needle-based Confocal Laser Endomicroscopy

Arm

Intervention/Treatment

Other: Lymph nodes, pancreatic masses & cysts

Procedure: EUS-FNA

Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle

Other Names:

ultrasonographic endoscopy

EUS-guided FNA

Device: nCLE

needle-based Confocal Laser Endomicroscopy

Outcome Measures

Primary Outcome Measures

Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts [Within 6 months after the end of Follow-up period]
Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes [Within one year after the end of the follow-up period]

Secondary Outcome Measures

Impact of the Cellvizio nCLE system on the management of a patient with pancreatic cyst [Within one year after the end of the follow-up period]
Validation of the interpretation criteria classification for pancreatic cysts [within 6 months after the end of the follow-up period]
Atlas of images of nCLE sequences of pancreatic masses and lymph nodes during EUS-FNA [within 3 months of the end of the follow-up period]
Diagnostic performance of nCLE in the diagnosis of pancreatic masses and lymph nodes, when associated with other diagnostic information [within one year after the end of the follow-up period]
Feasibility and safety data on nCLE during EUS-FNA procedure [Within 3 months after the end of the enrollment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female > 18 years of age.
Patient indicated for a first EUS-FNA for a pancreatic cyst, lymph node or pancreatic mass, or
Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for pancreatic cyst, lymph nodes, pancreatic mass, more than three months ago.
Patient with known pancreatic cyst or mass detected at cross-sectional imaging or suspicious lymph nodes reachable via EUSFNA
Willing and able to comply with study procedures and provide written informed consent to participate in the study.

Add for lymph nodes:

any lymph node reachable with EUS-FNA

Add for pancreatic mass:

any size
any location in the pancreas

Exclusion Criteria:

Subjects for whom EUS-FNA procedures are contraindicated
Known allergy to fluorescein dye
If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding

Add for cysts:

Subject with multiple cysts
size < 20mm in diameter
previous EUS-FNA procedure performed less than 3 months ago - Patients suffering chronic calcifying pancreatitis