Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract (US-nCLE)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2016 by Mauna Kea Technologies
Sponsor:
Mauna Kea Technologies
Information provided by (Responsible Party):
Mauna Kea Technologies
ClinicalTrials.gov Identifier:
NCT01770405
First received: January 10, 2013
Last updated: August 29, 2016
Last verified: August 2016
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study focuses on four different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract, pancreatic masses and GIST tumors.
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, Lymph nodes and GIST are less developed.
the objectives of the study are to
- Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
- Define/Validate descriptive criteria of nCLE sequences in masses and cystic tu-mors of the pancreas, lymph nodes, submucosal lesions of the GI tract
| Condition | Intervention |
|---|---|
|
Pancreatic Cyst Pancreatic Neoplasms Pancreatic Adenoma Pancreatic Cancer Pancreatic Islet Cell Tumors Lymph Node Mass Lymphadenopathy GIST |
Device: Endoscopic ultrasound fine needle aspiration |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration: | 1 Year |
| Official Title: | Registry Trial for Clinical Evaluation of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract |
Resource links provided by NLM:
Drug Information available for:
Pancrelipase
Genetic and Rare Diseases Information Center resources:
Pancreatic Islet Cell Tumors
Pancreatic Neuroendocrine Tumor
Pancreatic Adenoma
Carcinoid Tumor
Neuroepithelioma
U.S. FDA Resources
Further study details as provided by Mauna Kea Technologies:
Primary Outcome Measures:
- performance evaluation [ Time Frame: up to one year ] [ Designated as safety issue: No ]
- Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (accuracy evaluation)
- Define/Validate descriptive criteria for nCLE sequences in the characterization of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (image interpretation criteria definition
Secondary Outcome Measures:
- Safety and feasibility evaluation [ Time Frame: up to one month following the procedure ] [ Designated as safety issue: Yes ]
- Evaluate the feasibility and safety of nCLE for the characterization of masses and cystic tumors of the pan-creas, lymph nodes, submucosal lesions of the GI tract (IE. number of patients with complications, number of adverse events)
- Build an atlas of images of nCLE sequences of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2013 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
pancreatic cysts
Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst,
|
Device: Endoscopic ultrasound fine needle aspiration
Device: nCLE needle-based Confocal Laser Endomicroscopy
Other Names:
|
Detailed Description:
The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image organs within or adjacent to the GI or respiratory tracts by means of a miniprobe inserted through an endoscopic needle. The fundamental technology, as well as the principle of operation of nCLE, is substantially similar to pCLE.
endoscopic fine needles are used during EUS-FNA procedures to puncture solid organs such as the pancreas, in order to get tissue or fluid for diagnostic purposes. There are different calibers of endoscopic nee-dles used. The most commonly used calibers for EUS-FNA procedures are 22G, 19G, and 25G needles. The nCLE Confocal Miniprobe is compatible with the 19G-type needle only. It is expected to help to differentiate the different types of lesions, especially for cysts, leading to better patient management. Microscopic tissue information in real-time in vivo during an EUS-FNA procedure may allow better differentiation between mucinous and non-mucinous cysts for instance.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Referral patients with a clinical indication for masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract coming in for first EUS-FNA procedure at referral institution will be approached for possible inclusion into this registry
Criteria
Inclusion Criteria:
- - Male or female > 18 years of age
- Patient indicated for a first EUS-FNA for masses and cystic tumors of the pancreas, lymph nodes, submu-cosal lesions of the GI tract
- Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
- Patient with known masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
- For pancreatic cyst patient, suffering chronic calcifying pancreatitis
- For pancreatic mass patient, any size or location
- For lymph node patient, any node reachable with EUS-FNA
- Willing and able to comply with study procedures and provide written informed consent to participate in the registry
Exclusion Criteria:
- - Subjects for whom EUS-FNA procedures are contraindicated
- Known allergy to fluorescein contrast
- If female, breast feeding or pregnant based on a positive hCG serum or an in vitro diagnostic test result
- Subject with multiple cysts
- Cysts <20 mm in diameter
- Previous EUS-FNA procedure performed less than 3 months ago
- If several pancreatic masses, only one will be imaged during the nCLE procedure
- Lymph nodes <5 mm in diameter
- If several suspicious lymph nodes, only the most suspect will be imaged during the nCLE proce-dure
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770405
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770405
Contacts
| Contact: Divyesh V Sejpal, MD | 516-562-4281 | Dsejpal@NSHS.edu |
Locations
| United States, Georgia | |
| Emory University Hospital | Active, not recruiting |
| Atlanta, Georgia, United States, 30322 | |
| United States, New York | |
| North Shore-LIJ Health System | Recruiting |
| Manhasset, New York, United States, 11030 | |
| Contact: Divyesh V Sejpal, MD 516-562-4281 Dsejpal@NSHS.edu | |
| Principal Investigator: Divyesh Sejpal, MD | |
| Columbia University Medical Center | Not yet recruiting |
| New York, New York, United States, 10032 | |
| Contact: Frank Gress, MD 212-305-1909 fgg2109@cumc.columbia.edu | |
| Principal Investigator: Frank G Gress, MD | |
| United States, Pennsylvania | |
| Temple University Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Oleh Haluszka, MD Oleh.Haluszka@tuhs.temple.edu | |
| Principal Investigator: Oleh Haluszka, MD | |
Sponsors and Collaborators
Mauna Kea Technologies
Investigators
| Principal Investigator: | Divyesh V Sejpal, MD | Northwell Health |
More Information
| Responsible Party: | Mauna Kea Technologies |
| ClinicalTrials.gov Identifier: | NCT01770405 History of Changes |
| Other Study ID Numbers: | MKT_2012_nCLE_03 |
| Study First Received: | January 10, 2013 |
| Last Updated: | August 29, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mauna Kea Technologies:
|
endomicroscopy needle-based pancreatic |
cyst mass EUSFNA |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Adenoma Pancreatic Cyst Adenoma, Islet Cell Neuroendocrine Tumors Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases |
Pancreatic Diseases Endocrine System Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Cysts Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Pancrelipase Gastrointestinal Agents |
ClinicalTrials.gov processed this record on September 29, 2016