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

Phase 3
18 Years
Open (Enrolling)
Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Adenoma, Pancreatic Cancer, Pancreatic Islet Cell Tumors, Lymph Node, Lymphadenopathy

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Trial Information

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

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

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

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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts

Outcome Time Frame:

Within 6 months after the end of Follow-up period

Safety Issue:


Principal Investigator

Marc Giovannini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli-Calmettes


France: Committee for the Protection of Personnes

Study ID:




Start Date:

June 2012

Completion Date:

March 2014

Related Keywords:

  • Pancreatic Cyst
  • Pancreatic Neoplasms
  • Pancreatic Adenoma
  • Pancreatic Cancer
  • Pancreatic Islet Cell Tumors
  • Lymph Node
  • Lymphadenopathy
  • endomicroscopy
  • needle-based
  • pancreatic
  • cyst
  • mass
  • Adenoma
  • Neoplasms
  • Pancreatic Cyst
  • Pancreatic Neoplasms
  • Adenoma, Islet Cell
  • Lymphatic Diseases
  • Neuroendocrine Tumors