Pancreatic Cancer Clinical Trial
— CONTACTOfficial title:
Clinical Evaluation Of NCLE in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas
Verified date | August 2017 |
Source | Mauna Kea Technologies |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 330 |
Est. completion date | March 2019 |
Est. primary completion date | March 2, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Saint-Philibert | Lomme | |
France | Hôpital Jean Mermoz | Lyon | |
France | Institut Paoli Calmettes | Marseille |
Lead Sponsor | Collaborator |
---|---|
Mauna Kea Technologies |
France,
Adsay NV. Cystic neoplasia of the pancreas: pathology and biology. J Gastrointest Surg. 2008 Mar;12(3):401-4. Epub 2007 Oct 24. Review. — View Citation
Attasaranya S, Pais S, LeBlanc J, McHenry L, Sherman S, DeWitt JM. Endoscopic ultrasound-guided fine needle aspiration and cyst fluid analysis for pancreatic cysts. JOP. 2007 Sep 7;8(5):553-63. — View Citation
Becker V, Vercauteren T, von Weyhern CH, Prinz C, Schmid RM, Meining A. High-resolution miniprobe-based confocal microscopy in combination with video mosaicing (with video). Gastrointest Endosc. 2007 Nov;66(5):1001-7. Epub 2007 Sep 4. — View Citation
Becker V, Wallace MB, Fockens P, von Delius S, Woodward TA, Raimondo M, Voermans RP, Meining A. Needle-based confocal endomicroscopy for in vivo histology of intra-abdominal organs: first results in a porcine model (with videos). Gastrointest Endosc. 2010 Jun;71(7):1260-6. doi: 10.1016/j.gie.2010.01.010. Epub 2010 Apr 24. — View Citation
Bhutani MS. Role of endoscopic ultrasonography in the diagnosis and treatment of cystic tumors of the pancreas. JOP. 2004 Jul;5(4):266-72. Review. — View Citation
Buchner AM, Shahid MW, Heckman MG, Krishna M, Ghabril M, Hasan M, Crook JE, Gomez V, Raimondo M, Woodward T, Wolfsen HC, Wallace MB. Comparison of probe-based confocal laser endomicroscopy with virtual chromoendoscopy for classification of colon polyps. Gastroenterology. 2010 Mar;138(3):834-42. doi: 10.1053/j.gastro.2009.10.053. Epub 2009 Nov 10. — View Citation
Giovannini M, Caillol F, Poizat F, Bories E, Pesenti C, Monges G, Raoul JL. Feasibility of Intratumoral Confocal Microscopy under Endoscopic Ultrasound Guidance. Endosc Ultrasound. 2012 Jul;1(2):80-3. doi: 10.7178/eus.02.005. — View Citation
Hutchins GF, Draganov PV. Cystic neoplasms of the pancreas: a diagnostic challenge. World J Gastroenterol. 2009 Jan 7;15(1):48-54. Review. — View Citation
Khalid A, Brugge W. ACG practice guidelines for the diagnosis and management of neoplastic pancreatic cysts. Am J Gastroenterol. 2007 Oct;102(10):2339-49. Epub 2007 Aug 31. Review. — View Citation
Kiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF. In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. Epub 2006 Jul 13. — View Citation
Konda VJ, Aslanian HR, Wallace MB, Siddiqui UD, Hart J, Waxman I. First assessment of needle-based confocal laser endomicroscopy during EUS-FNA procedures of the pancreas (with videos). Gastrointest Endosc. 2011 Nov;74(5):1049-60. doi: 10.1016/j.gie.2011.07.018. Epub 2011 Sep 15. — View Citation
Levy MJ, Clain JE. Evaluation and management of cystic pancreatic tumors: emphasis on the role of EUS FNA. Clin Gastroenterol Hepatol. 2004 Aug;2(8):639-53. Review. — View Citation
Meining A, Frimberger E, Becker V, Von Delius S, Von Weyhern CH, Schmid RM, Prinz C. Detection of cholangiocarcinoma in vivo using miniprobe-based confocal fluorescence microscopy. Clin Gastroenterol Hepatol. 2008 Sep;6(9):1057-60. doi: 10.1016/j.cgh.2008.04.014. Epub 2008 Jul 17. — View Citation
Meining A, Phillip V, Gaa J, Prinz C, Schmid RM. Pancreaticoscopy with miniprobe-based confocal laser-scanning microscopy of an intraductal papillary mucinous neoplasm (with video). Gastrointest Endosc. 2009 May;69(6):1178-80. doi: 10.1016/j.gie.2008.06.013. Epub 2009 Jan 18. — View Citation
Meining A, Saur D, Bajbouj M, Becker V, Peltier E, Höfler H, von Weyhern CH, Schmid RM, Prinz C. In vivo histopathology for detection of gastrointestinal neoplasia with a portable, confocal miniprobe: an examiner blinded analysis. Clin Gastroenterol Hepatol. 2007 Nov;5(11):1261-7. Epub 2007 Aug 6. — View Citation
Pohl H, Rösch T, Vieth M, Koch M, Becker V, Anders M, Khalifa AC, Meining A. Miniprobe confocal laser microscopy for the detection of invisible neoplasia in patients with Barrett's oesophagus. Gut. 2008 Dec;57(12):1648-53. doi: 10.1136/gut.2008.157461. Epub 2008 Aug 28. — View Citation
Sahani DV, Kadavigere R, Saokar A, Fernandez-del Castillo C, Brugge WR, Hahn PF. Cystic pancreatic lesions: a simple imaging-based classification system for guiding management. Radiographics. 2005 Nov-Dec;25(6):1471-84. Review. — View Citation
Wallace MB, Meining A, Canto MI, Fockens P, Miehlke S, Roesch T, Lightdale CJ, Pohl H, Carr-Locke D, Löhr M, Coron E, Filoche B, Giovannini M, Moreau J, Schmidt C, Kiesslich R. The safety of intravenous fluorescein for confocal laser endomicroscopy in the gastrointestinal tract. Aliment Pharmacol Ther. 2010 Mar;31(5):548-52. doi: 10.1111/j.1365-2036.2009.04207.x. Epub 2009 Nov 30. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts | Within 6 months after the end of Follow-up period | ||
Primary | Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes | Within one year after the end of the follow-up period | ||
Secondary | Impact of the Cellvizio nCLE system on the management of a patient with pancreatic cyst | Within one year after the end of the follow-up period | ||
Secondary | Validation of the interpretation criteria classification for pancreatic cysts | within 6 months after the end of the follow-up period | ||
Secondary | Atlas of images of nCLE sequences of pancreatic masses and lymph nodes during EUS-FNA | within 3 months of the end of the follow-up period | ||
Secondary | Diagnostic performance of nCLE in the diagnosis of pancreatic masses and lymph nodes, when associated with other diagnostic information | within one year after the end of the follow-up period | ||
Secondary | Feasibility and safety data on nCLE during EUS-FNA procedure | Within 3 months after the end of the enrollment period |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05305001 -
Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
Recruiting |
NCT04927780 -
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
|
Phase 3 | |
Recruiting |
NCT06054984 -
TCR-T Cells in the Treatment of Advanced Pancreatic Cancer
|
Early Phase 1 | |
Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
Terminated |
NCT03140670 -
Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy
|
Phase 2 | |
Terminated |
NCT00529113 -
Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer
|
Phase 1 | |
Recruiting |
NCT05168527 -
The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05391126 -
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
|
N/A | |
Terminated |
NCT03300921 -
A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer
|
Phase 1 | |
Completed |
NCT03153410 -
Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas
|
Early Phase 1 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05679583 -
Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT04183478 -
The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer
|
Phase 2/Phase 3 | |
Terminated |
NCT03600623 -
Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer
|
Early Phase 1 | |
Recruiting |
NCT04584008 -
Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics
|
N/A | |
Recruiting |
NCT05351983 -
Patient-derived Organoids Drug Screen in Pancreatic Cancer
|
N/A | |
Completed |
NCT04290364 -
Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study
|