CholangiocarcinomaEUSERCPRegNCT01522573
T-EUS for Gastrointestinal Disorders: A Multicenter Registry
An observational study of Cholangiocarcinoma and Pancreatic Cancer, run by Weill Medical College of Cornell University at 2 sites in 2 countries.
Trial summary
The purpose of this registry is to record information and evaluate the impact of Endoscopic Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP) on the management of pancreatico-biliary disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Cancer
- What is being tested?
- EUS guided ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2011to 30 Dec 2018
- 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: Subjects who has undergone Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP) procedure for diagnosis or treatment of a pancreatico-biliary disorder. Above 18 years of age.
Who may be able to join
- Any patient who has undergone EUS-guided ERCP (Endoscopic Retrograde Cholangiopancreatography)for diagnosis or treatment of a pancreatico-biliary disorder.
- Above 18 years of age.
Who cannot join
- Any subject who has not undergone Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP).
- Below 18 years of age.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medical College
New York, New York, 10021
Michel Kahaleh, MD, 646-962-4797, mkahaleh@gmail.com
Monica Gaidhane, MPH, 646-962-4796, mog2012@med.cornell.edu
Brazil1 site, 1 recruiting
- Recruiting
Prof. Dr. Everson L.A. Artifon
São Paulo, 01246-903
Everson LA Artifon, MD, 3061-7345, eartifon@hotmail.com
Everson LA Artifon, MD
About this study
Official title: Therapeutic Endoscopic Ultrasound (T-EUS) Guided Procedures in the Management of Gastrointestinal Disorders: A Multicenter Registry.
The purpose of this registry is to record information and evaluate the impact of Endoscopic Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP) on the management of pancreatico-biliary disorders. The registry will evaluate efficacy, safety and technical success of the Endoscopic Ultrasound (EUS)Guided Endoscopic retrograde cholangiopancreatography (ERCP) procedures. The safety and efficacy of various EUS-Guided ERCP procedures have been assessed in a series of studies.
This multi-center registry has been initiated:
Read more
- To document the impact of EUS-Guided ERCP procedures on the management of pancreatico-biliary disorders including malignancies.
- To assess the clinical and technical success rates of EUS-Guided ERCPs for diagnostic or therapeutic procedures.
Design is retrospective and prospective registry study.
Procedures that will be captured include:
- EUS-Coils placement
- EUS Glue injection
- EUS-Fiducial placement
- EUS-Neurolysis
- EUS-Stent placement
- EUS-alcohol injection
- EUS-fluid collection, abscess or cavity drainage
- EUS guided ductal drainage
- EUS-guided Ablation
- EUS-guided anastomosis 11. EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage
Read the detailed description
Endoscopic Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP) has become a therapeutic intervention for the management of biliary obstruction or pancreatic strictures related to chronic pancreatitis or other diseases. Successful biliary or pancreatic cannulation can be achieved in 90 to 97%. Failure to obtain biliary access can be related to operator experience, peri-ampullary diverticula, prior surgery (e.g., Billroth II anatomy), tumor involvement of the ampulla, biliary sphincter stenosis and impacted stones. In experienced hands, pancreatic duct cannulation fails in less than 10% of cases. This is primarily related to surgically altered anatomy or inflammation. Referral to a tertiary care center , percutaneous intrahepatic cholangiography (PTC) for biliary decompression , and surgical intervention are typically offered after a failed ERCP. Percutaneous intrahepatic cholangiography with subsequent percutaneous or endoscopic drainage has a morbidity of up to 32%. Surgery can also be associated with significant morbidity and mortality.
Endoscopic ultrasound (EUS) allows detailed imaging of the regional anatomy by approximating the frequency transducer to the region of interest. With the evolution of linear array and the ability to direct a needle within the field of interest, the therapeutic potential of EUS has reached new levels beyond fine needle aspiration (FNA), celiac plexus blocks and drainage of cystic lesions. The biliary and pancreatic systems, being in close proximity to the gastric or duodenal lumen, are a logical target for EUS in cases not accessible by ERCP. EUS-assisted cholangiopancreatography was described a decade ago. In order to validate these procedures and broaden its use beyond tertiary centers, it is crucial to understand its efficacy and success rate. The objective of the study is to evaluate retrospectively and prospectively the efficacy and safety of EUS-Guided ERCP procedures for the diagnosis and treatment of pancreatico-biliary disorders.
The purpose of this registry is to record information and evaluate the impact of EUS-Guided ERCP on the management of pancreatico-biliary disorders. The registry will evaluate efficacy, safety and technical success of the EUS-Guided ERCP procedures.
The involvement of multi-international sites is crucial- as the advanced endoscopists outside US are attempting similar complex EUS-Guided ERCPs for complicated pancreatico-biliary cases as their counterparts in US. However, because of the non-existence of a registry, these cases are often reported as isolated case series with remarkable technical similarities to case series in other countries.
The registry hopes to combine all such comparable cases and collect enough relevant data for statistical analyses.
- Conditions
- Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Cancer, Biliary Stricture, Biliary Obstruction, Stent Obstruction
- Being tested
- EUS guided ERCP
- Keywords
- Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Cancer, Biliary Stricture, Biliary obstruction, Stent obstruction, Proximal duct stricture, Distal duct stricture, Ampullary Cancer, Biliary sphincter stenosis, Impacted stones, Chronic pancreatitis, Peri-ampullary diverticula, Altered anatomy, Endoscopic ultrasound, Endoscopic Retrograde Cholangiopancreatography, Multicenter
- Medical subject headings
- Cholangiocarcinoma, Pancreatic Neoplasms, Bile Duct Neoplasms, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS guided ERCPProcedure or surgery
Also called EUS ERCP
Endoscopic ultrasound guided (EUS) endoscopic retrograde cholangiopancreatography (ERCP)
| Study group | Role | What they receive |
|---|---|---|
| EUS guided ERCP procedure group | Subjects who will undergo Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP) procedures for their pancreatico-biliary conditions. Receives: Procedure: EUS guided ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Documentation of Safety- Number of Participants with Adverse Events; Type, frequency and intensity of adverse events
Measured: 3 years
Secondary outcomes (2)
Efficacy
Documentation of efficacy: Technical and clinical success rates.
- Technical Success rate will be derived from reported success or failure of technical feasibility and conduction of a specific EUS Guided ERCP procedure for a pancreatico-biliary condition.
- Clinical success rate will be derived from reported of clinical success hallmarks such as biliary or pancreatic drainage, reduction in total bilirubin, formation of a fistula, immediate and eventual alleviation of symptoms or complaints within a specific period of time, etc. for that particular pancreatico-biliary disorder.
Measured: 3 years
Survival duration
Documentation of response rates and overall survival duration.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startNov 2011
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Kahaleh, Weill Medical College of Cornell University
- Investigators
- Michel Kahaleh, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522573
- Sponsor's protocol ID
- 1111012016
- Acronym
- EUSERCPReg
- Status last verified
- Feb 2017
- First submitted
- 26 Jan 2012
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Tyberg A, Kats D, Choi A, Gaidhane M, Nieto J, Kahaleh M. Endoscopic Ultrasound Guided Gastroenterostomy: What Is the Learning Curve? J Clin Gastroenterol. 2021 Sep 1;55(8):691-693. doi: 10.1097/MCG.0000000000001400.
PubMed 32740096Kumta NA, Tyberg A, Bhagat VH, Siddiqui AA, Kowalski TE, Loren DE, Desai AP, Sarkisian AM, Brown EG, Karia K, Gaidhane M, Kedia P, Tarnasky PR, Patel U, Adler D, Taylor LJ, Petrone M, Arcidiacono P, Yachimski PS, Weine D, Sundararajan S, Deprez PH, Mouradides C, Ho S, Javed S, Easler JJ, Raijman I, Vazquez-Sequeiros E, Sawhney M, Berzin TM, Kahaleh M. EUS-guided drainage of pancreatic fluid collections using lumen apposing metal stents: An international, multicenter experience. Dig Liver Dis. 2019 Nov;51(11):1557-1561. doi: 10.1016/j.dld.2019.05.033. Epub 2019 Jul 2.
PubMed 31272934Siddiqui A, Kunda R, Tyberg A, Arain MA, Noor A, Mumtaz T, Iqbal U, Loren DE, Kowalski TE, Adler DG, Saumoy M, Gaidhane M, Mallery S, Christiansen EM, Nieto J, Kahaleh M. Three-way comparative study of endoscopic ultrasound-guided transmural gallbladder drainage using lumen-apposing metal stents versus endoscopic transpapillary drainage versus percutaneous cholecystostomy for gallbladder drainage in high-risk surgical patients with acute cholecystitis: clinical outcomes and success in an International, Multicenter Study. Surg Endosc. 2019 Apr;33(4):1260-1270. doi: 10.1007/s00464-018-6406-7. Epub 2018 Sep 12.
PubMed 30209610Tyberg A, Sharaiha RZ, Kedia P, Kumta N, Gaidhane M, Artifon E, Giovannini M, Kahaleh M. EUS-guided pancreatic drainage for pancreatic strictures after failed ERCP: a multicenter international collaborative study. Gastrointest Endosc. 2017 Jan;85(1):164-169. doi: 10.1016/j.gie.2016.07.030. Epub 2016 Jul 25.
PubMed 27460387Kahaleh M, Perez-Miranda M, Artifon EL, Sharaiha RZ, Kedia P, Penas I, De la Serna C, Kumta NA, Marson F, Gaidhane M, Boumitri C, Parra V, Rondon Clavo CM, Giovannini M. International collaborative study on EUS-guided gallbladder drainage: Are we ready for prime time? Dig Liver Dis. 2016 Sep;48(9):1054-7. doi: 10.1016/j.dld.2016.05.021. Epub 2016 Jun 3.
PubMed 27328985Tyberg A, Perez-Miranda M, Sanchez-Ocana R, Penas I, de la Serna C, Shah J, Binmoeller K, Gaidhane M, Grimm I, Baron T, Kahaleh M. Endoscopic ultrasound-guided gastrojejunostomy with a lumen-apposing metal stent: a multicenter, international experience. Endosc Int Open. 2016 Mar;4(3):E276-81. doi: 10.1055/s-0042-101789.
PubMed 27004243Kedia P, Tyberg A, Kumta NA, Gaidhane M, Karia K, Sharaiha RZ, Kahaleh M. EUS-directed transgastric ERCP for Roux-en-Y gastric bypass anatomy: a minimally invasive approach. Gastrointest Endosc. 2015 Sep;82(3):560-5. doi: 10.1016/j.gie.2015.03.1913. Epub 2015 May 5.
PubMed 25952086
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Endoscopic Ultrasound (T-EUS) Guided Procedures in the Management of Gastrointestinal Disorders: A Multicenter Registry.
- ClinicalTrials.gov ID
- NCT01522573
- Acronym / sponsor ID
- EUSERCPReg / 1111012016
- Conditions
- Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Cancer, Biliary Stricture, Biliary Obstruction, Stent Obstruction
- Keywords
- Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Cancer, Biliary Stricture, Biliary obstruction, Stent obstruction, Proximal duct stricture, Distal duct stricture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 31 Jan 2012 (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.
The purpose of this registry is to record information and evaluate the impact of Endoscopic Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP) on the management of pancreatico-biliary disorders. The registry will evaluate efficacy, safety and technical success of the Endoscopic Ultrasound (EUS)Guided Endoscopic retrograde cholangiopancreatography (ERCP) procedures. The safety and efficacy of various EUS-Guided ERCP procedures have been assessed in a series of studies.
This multi-center registry has been initiated:
- To document the impact of EUS-Guided ERCP procedures on the management of pancreatico-biliary disorders including malignancies.
- To assess the clinical and technical success rates of EUS-Guided ERCPs for diagnostic or therapeutic procedures.
Design is retrospective and prospective registry study.
Procedures that will be captured include:
- EUS-Coils placement
- EUS Glue injection
- EUS-Fiducial placement
- EUS-Neurolysis
- EUS-Stent placement
- EUS-alcohol injection
- EUS-fluid collection, abscess or cavity drainage
- EUS guided ductal drainage
- EUS-guided Ablation
- EUS-guided anastomosis 11. EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage
Detailed description
Endoscopic Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP) has become a therapeutic intervention for the management of biliary obstruction or pancreatic strictures related to chronic pancreatitis or other diseases. Successful biliary or pancreatic cannulation can be achieved in 90 to 97%. Failure to obtain biliary access can be related to operator experience, peri-ampullary diverticula, prior surgery (e.g., Billroth II anatomy), tumor involvement of the ampulla, biliary sphincter stenosis and impacted stones. In experienced hands, pancreatic duct cannulation fails in less than 10% of cases. This is primarily related to surgically altered anatomy or inflammation. Referral to a tertiary care center , percutaneous intrahepatic cholangiography (PTC) for biliary decompression , and surgical intervention are typically offered after a failed ERCP. Percutaneous intrahepatic cholangiography with subsequent percutaneous or endoscopic drainage has a morbidity of up to 32%. Surgery can also be associated with significant morbidity and mortality.
Endoscopic ultrasound (EUS) allows detailed imaging of the regional anatomy by approximating the frequency transducer to the region of interest. With the evolution of linear array and the ability to direct a needle within the field of interest, the therapeutic potential of EUS has reached new levels beyond fine needle aspiration (FNA), celiac plexus blocks and drainage of cystic lesions. The biliary and pancreatic systems, being in close proximity to the gastric or duodenal lumen, are a logical target for EUS in cases not accessible by ERCP. EUS-assisted cholangiopancreatography was described a decade ago. In order to validate these procedures and broaden its use beyond tertiary centers, it is crucial to understand its efficacy and success rate. The objective of the study is to evaluate retrospectively and prospectively the efficacy and safety of EUS-Guided ERCP procedures for the diagnosis and treatment of pancreatico-biliary disorders.
The purpose of this registry is to record information and evaluate the impact of EUS-Guided ERCP on the management of pancreatico-biliary disorders. The registry will evaluate efficacy, safety and technical success of the EUS-Guided ERCP procedures.
The involvement of multi-international sites is crucial- as the advanced endoscopists outside US are attempting similar complex EUS-Guided ERCPs for complicated pancreatico-biliary cases as their counterparts in US. However, because of the non-existence of a registry, these cases are often reported as isolated case series with remarkable technical similarities to case series in other countries.
The registry hopes to combine all such comparable cases and collect enough relevant data for statistical analyses.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS guided ERCP procedure group | – | Procedure: EUS guided ERCPSubjects who will undergo Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP) procedures for their pancreatico-biliary conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who has undergone Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP) procedure for diagnosis or treatment of a pancreatico-biliary disorder. Above 18 years of age.
Key inclusion criteria (2 listed)
- Any patient who has undergone EUS-guided ERCP (Endoscopic Retrograde Cholangiopancreatography)for diagnosis or treatment of a pancreatico-biliary disorder.
- Above 18 years of age.
Key exclusion criteria (2 listed)
- Any subject who has not undergone Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP).
- Below 18 years of age.
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 |
|---|---|---|
| EUS guided ERCPAlso: EUS ERCPEndoscopic ultrasound guided (EUS) endoscopic retrograde cholangiopancreatography (ERCP) | Procedure or surgery | EUS guided ERCP procedure group |
Primary outcome
Safety
Time frame: 3 years
Documentation of Safety- Number of Participants with Adverse Events; Type, frequency and intensity of adverse events
2 secondary outcomes
Efficacy
Time frame: 3 years
Survival duration
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Derived from this study: PubMed 32740096Tyberg A, Kats D, Choi A, Gaidhane M, Nieto J, Kahaleh M. Endoscopic Ultrasound Guided Gastroenterostomy: What Is the Learning Curve? J Clin Gastroenterol. 2021 Sep 1;55(8):691-693. doi: 10.1097/MCG.0000000000001400.
- Derived from this study: PubMed 31272934Kumta NA, Tyberg A, Bhagat VH, Siddiqui AA, Kowalski TE, Loren DE, Desai AP, Sarkisian AM, Brown EG, Karia K, Gaidhane M, Kedia P, Tarnasky PR, Patel U, Adler D, Taylor LJ, Petrone M, Arcidiacono P, Yachimski PS, Weine D, Sundararajan S, Deprez PH, Mouradides C, Ho S, Javed S, Easler JJ, Raijman I, Vazquez-Sequeiros E, Sawhney M, Berzin TM, Kahaleh M. EUS-guided drainage of pancreatic fluid collections using lumen apposing metal stents: An international, multicenter experience. Dig Liver Dis. 2019 Nov;51(11):1557-1561. doi: 10.1016/j.dld.2019.05.033. Epub 2019 Jul 2.
- Derived from this study: PubMed 30209610Siddiqui A, Kunda R, Tyberg A, Arain MA, Noor A, Mumtaz T, Iqbal U, Loren DE, Kowalski TE, Adler DG, Saumoy M, Gaidhane M, Mallery S, Christiansen EM, Nieto J, Kahaleh M. Three-way comparative study of endoscopic ultrasound-guided transmural gallbladder drainage using lumen-apposing metal stents versus endoscopic transpapillary drainage versus percutaneous cholecystostomy for gallbladder drainage in high-risk surgical patients with acute cholecystitis: clinical outcomes and success in an International, Multicenter Study. Surg Endosc. 2019 Apr;33(4):1260-1270. doi: 10.1007/s00464-018-6406-7. Epub 2018 Sep 12.
- Derived from this study: PubMed 27460387Tyberg A, Sharaiha RZ, Kedia P, Kumta N, Gaidhane M, Artifon E, Giovannini M, Kahaleh M. EUS-guided pancreatic drainage for pancreatic strictures after failed ERCP: a multicenter international collaborative study. Gastrointest Endosc. 2017 Jan;85(1):164-169. doi: 10.1016/j.gie.2016.07.030. Epub 2016 Jul 25.
- Derived from this study: PubMed 27328985Kahaleh M, Perez-Miranda M, Artifon EL, Sharaiha RZ, Kedia P, Penas I, De la Serna C, Kumta NA, Marson F, Gaidhane M, Boumitri C, Parra V, Rondon Clavo CM, Giovannini M. International collaborative study on EUS-guided gallbladder drainage: Are we ready for prime time? Dig Liver Dis. 2016 Sep;48(9):1054-7. doi: 10.1016/j.dld.2016.05.021. Epub 2016 Jun 3.
- Derived from this study: PubMed 27004243Tyberg A, Perez-Miranda M, Sanchez-Ocana R, Penas I, de la Serna C, Shah J, Binmoeller K, Gaidhane M, Grimm I, Baron T, Kahaleh M. Endoscopic ultrasound-guided gastrojejunostomy with a lumen-apposing metal stent: a multicenter, international experience. Endosc Int Open. 2016 Mar;4(3):E276-81. doi: 10.1055/s-0042-101789.
- Derived from this study: PubMed 25952086Kedia P, Tyberg A, Kumta NA, Gaidhane M, Karia K, Sharaiha RZ, Kahaleh M. EUS-directed transgastric ERCP for Roux-en-Y gastric bypass anatomy: a minimally invasive approach. Gastrointest Endosc. 2015 Sep;82(3):560-5. doi: 10.1016/j.gie.2015.03.1913. Epub 2015 May 5.
Related trials for Cholangiocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
Biliary Cancer, Bile Duct Cancer
RecruitingPhase 2
Combination Therapy Using Durvalumab and Histotripsy for Treatment of Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 2
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
Sarcoma, Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC)
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.
Michel Kahaleh, MD principal investigator
Weill Medical College of Cornell University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma and Pancreatic Cancer, run by Weill Medical College of Cornell University at 2 sites in 2 countries.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01522573, which also lists 7 linked publications.
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 20 Feb 2017.