Clinical trial NCT01563133: Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas
Official title: Clinical Evaluation Of NCLE in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cyst
Pancreatic Neoplasms
Pancreatic Adenoma
Pancreatic Cancer
Pancreatic Islet Cell Tumors
Lymph Node
Lymphadenopathy
Keywords: endomicroscopy
needle-based
pancreatic
cyst
mass
EUSFNA
Lead sponsor: Mauna Kea Technologies
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

1. 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.
2. 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.

Detailed description: 1. 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.
2. 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.
3. 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.
4. 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
5. Design This study will be conducted in three centers in France.

Eligibility criteria: 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

Add for lymph nodes:

* size \< 5mm in diameter
* If patients present several suspicious lymph nodes, only one of them will be imaged during the nCLE procedure

Add for pancreatic mass:

- If patient present several pancreatic masses, only one of them will be imaged during the nCLE procedure

Primary outcomes:
measure: Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts
timeFrame: Within 6 months after the end of Follow-up period
measure: Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes
timeFrame: Within one year after the end of the follow-up period
Secondary outcomes:
measure: Impact of the Cellvizio nCLE system on the management of a patient with pancreatic cyst
timeFrame: Within one year after the end of the follow-up period
measure: Validation of the interpretation criteria classification for pancreatic cysts
timeFrame: within 6 months after the end of the follow-up period
measure: Atlas of images of nCLE sequences of pancreatic masses and lymph nodes during EUS-FNA
timeFrame: within 3 months of the end of the follow-up period
measure: Diagnostic performance of nCLE in the diagnosis of pancreatic masses and lymph nodes, when associated with other diagnostic information
timeFrame: within one year after the end of the follow-up period
measure: Feasibility and safety data on nCLE during EUS-FNA procedure
timeFrame: Within 3 months after the end of the enrollment period
Other outcomes:
Locations:
city: Lomme
country: France
facility: Hôpital Saint-Philibert
city: Lyon
country: France
facility: Hôpital Jean Mermoz
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Marc Giovannini, MD
role: PRINCIPAL_INVESTIGATOR
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