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

Primary Purpose

Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Adenoma

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EUS-FNA
nCLE
Sponsored by
Mauna Kea Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cyst focused on measuring endomicroscopy, needle-based, pancreatic, cyst, mass, EUSFNA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • Hôpital Saint-Philibert
  • Hôpital Jean Mermoz
  • Institut Paoli Calmettes

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lymph nodes, pancreatic masses & cysts

Arm Description

Outcomes

Primary Outcome Measures

Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts
Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes

Secondary Outcome Measures

Impact of the Cellvizio nCLE system on the management of a patient with pancreatic cyst
Validation of the interpretation criteria classification for pancreatic cysts
Atlas of images of nCLE sequences of pancreatic masses and lymph nodes during EUS-FNA
Diagnostic performance of nCLE in the diagnosis of pancreatic masses and lymph nodes, when associated with other diagnostic information
Feasibility and safety data on nCLE during EUS-FNA procedure

Full Information

First Posted
March 22, 2012
Last Updated
August 28, 2017
Sponsor
Mauna Kea Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT01563133
Brief Title
Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas
Acronym
CONTACT
Official Title
Clinical Evaluation Of NCLE in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2, 2016 (Actual)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mauna Kea Technologies

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Adenoma, Pancreatic Cancer, Pancreatic Islet Cell Tumors, Lymph Node, Lymphadenopathy
Keywords
endomicroscopy, needle-based, pancreatic, cyst, mass, EUSFNA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lymph nodes, pancreatic masses & cysts
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
EUS-FNA
Other Intervention Name(s)
ultrasonographic endoscopy, EUS-guided FNA
Intervention Description
Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle
Intervention Type
Device
Intervention Name(s)
nCLE
Intervention Description
needle-based Confocal Laser Endomicroscopy
Primary Outcome Measure Information:
Title
Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts
Time Frame
Within 6 months after the end of Follow-up period
Title
Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes
Time Frame
Within one year after the end of the follow-up period
Secondary Outcome Measure Information:
Title
Impact of the Cellvizio nCLE system on the management of a patient with pancreatic cyst
Time Frame
Within one year after the end of the follow-up period
Title
Validation of the interpretation criteria classification for pancreatic cysts
Time Frame
within 6 months after the end of the follow-up period
Title
Atlas of images of nCLE sequences of pancreatic masses and lymph nodes during EUS-FNA
Time Frame
within 3 months of the end of the follow-up period
Title
Diagnostic performance of nCLE in the diagnosis of pancreatic masses and lymph nodes, when associated with other diagnostic information
Time Frame
within one year after the end of the follow-up period
Title
Feasibility and safety data on nCLE during EUS-FNA procedure
Time Frame
Within 3 months after the end of the enrollment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Giovannini, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Saint-Philibert
City
Lomme
ZIP/Postal Code
59462
Country
France
Facility Name
Hôpital Jean Mermoz
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France

12. IPD Sharing Statement

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

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