Pancreatic CystUS-nCLENCT01770405
Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract
An observational study of Pancreatic Cyst and Pancreatic Neoplasms, run by Mauna Kea Technologies at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Adenoma
- What is being tested?
- Endoscopic ultrasound fine needle aspiration
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2013to 21 Dec 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- - 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
Who cannot join
- - 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
Show all 9Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University Hospital
Atlanta, Georgia, 30322
North Shore-LIJ Health System
Manhasset, New York, 11030
Columbia University Medical Center
New York, New York, 10032
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
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
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.
Read more
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
Read the 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.
- Conditions
- Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Adenoma, Pancreatic Cancer, Pancreatic Islet Cell Tumors, Lymph Node Mass
- Being tested
- Endoscopic ultrasound fine needle aspiration
- Keywords
- endomicroscopy, needle-based, pancreatic, cyst, mass, EUSFNA
- Medical subject headings
- Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic adenoma, Adenoma, Islet Cell, Lymphadenopathy, Cysts, Arachnodactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound fine needle aspirationDevice
Also called ultrasonographic endoscopy, EUS-guided FNA
Device: nCLE needle-based Confocal Laser Endomicroscopy
| Study group | Role | What they receive |
|---|---|---|
| pancreatic cysts | Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst, Receives: Device: Endoscopic ultrasound fine needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance evaluation
- 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
Measured: up to one year
Secondary outcomes (1)
Safety and feasibility evaluation
- 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
Measured: up to one month following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startSep 2013
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Mauna Kea Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Divyesh V Sejpal, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770405
- Sponsor's protocol ID
- MKT_2012_nCLE_03
- Acronym
- US-nCLE
- Status last verified
- Aug 2017
- First submitted
- 10 Jan 2013
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01770405
- Acronym / sponsor ID
- US-nCLE / MKT_2012_nCLE_03
- Conditions
- Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Adenoma, Pancreatic Cancer, Pancreatic Islet Cell Tumors, Lymph Node Mass
- Keywords
- endomicroscopy, needle-based, pancreatic, cyst, mass, EUSFNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mauna Kea TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pancreatic cysts | – | Device: Endoscopic ultrasound fine needle aspirationPatient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- - 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
Key exclusion criteria (9 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasound fine needle aspirationAlso: ultrasonographic endoscopy, EUS-guided FNADevice: nCLE needle-based Confocal Laser Endomicroscopy | Device | pancreatic cysts |
Primary outcome
performance evaluation
Time frame: up to one year
* 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
1 secondary outcome
Safety and feasibility evaluation
Time frame: up to one month following the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Divyesh V Sejpal, MD principal investigator
Northwell Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cyst and Pancreatic Neoplasms, run by Mauna Kea Technologies at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performance evaluation (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.