Gastrointestinal Motility in Patients With Neuroendocrine Tumors
Primary Purpose
Neuroendocrine Tumor
Status
Completed
Phase
Locations
Denmark
Study Type
Observational
Intervention
Magnetic Tracking System (MTS) and radio-opaque markers
Sponsored by
About this trial
This is an observational trial for Neuroendocrine Tumor focused on measuring Neuroendocrine tumor, Carcinoid syndrome, Motility, Transit time
Eligibility Criteria
Inclusion Criteria:
- NET confirmed by histology
- Diarrhea, (at least 3 loose or watery bowel movements per day) as part of carcinoid syndrome.
- Newly referred patients without previous somatostatin analogue treatment or
- NET patients who are pausing somatostatin analogue treatment due to other treatment or examination.
Exclusion Criteria:
- Subjects unable to understand the information
- Severe diabetes with late complications or known metabolic disorder
- Inflammatory bowel disease
- Known clinically significant stenosis of the bowel
- Bile acid malabsorption due to intestinal surgery
- Small bowl bacterial overgrowth
Sites / Locations
- Analfysiologisk afsnit, Aarhus University Hospital, Tage Hansensgade, entrance 11A
Arms of the Study
Arm 1
Arm Type
Arm Label
Patients with NET and diarrhea.
Arm Description
Outcomes
Primary Outcome Measures
Gastrointestinal transit time in NET patients
Secondary Outcome Measures
Gastric emptying in NET patients
Small intestinal transit time
Small intestinal velocity
Changes in carcinoid symptoms and biomarkers
Full Information
NCT ID
NCT00789841
First Posted
November 11, 2008
Last Updated
October 25, 2010
Sponsor
University of Aarhus
Collaborators
Novartis, The Danish Medical Research Council
1. Study Identification
Unique Protocol Identification Number
NCT00789841
Brief Title
Gastrointestinal Motility in Patients With Neuroendocrine Tumors
Official Title
Gastrointestinal Motility in Patients With Neuroendocrine Tumors-Effects of Sandostatin LAR
Study Type
Observational
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
Collaborators
Novartis, The Danish Medical Research Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We will study the total gastrointestinal transit time (GITT), gastric emptying and small intestine motility in NET patients before and after treated with somatostatin analogues and compare these to healthy subjects. For this we will use radio-opaque markers and the newly developed Motility Tracking System (MTS).
Hypothesis: Patients with NET and carcinoid syndrome have decreased GITT, gastric emptying and small bowel transit time and an increase in phase III MMC activity compared to healthy subjects. Treatment with somatostatin analogues increase transit times and decrease phase III MMC activity and improves the clinical symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumor
Keywords
Neuroendocrine tumor, Carcinoid syndrome, Motility, Transit time
7. Study Design
Enrollment
13 (Actual)
Biospecimen Retention
Samples With DNA
Biospecimen Description
Blood samples wich are destroyed after analysis
8. Arms, Groups, and Interventions
Arm Title
Patients with NET and diarrhea.
Intervention Type
Device
Intervention Name(s)
Magnetic Tracking System (MTS) and radio-opaque markers
Intervention Description
MTS: A small magnetic pill (6x15mm) is swallowed by the patient and the movement of this pill is registered by a sensor (coordinates x,y,z angles θ, φ) and depicted af graphs on a computer screen. For determination of GITT a capsule containing 10 radio-opaque markers is ingested every day for six days, on day seven an abdominal x-ray is performed.
Primary Outcome Measure Information:
Title
Gastrointestinal transit time in NET patients
Time Frame
End of the study
Secondary Outcome Measure Information:
Title
Gastric emptying in NET patients
Time Frame
End of the study
Title
Small intestinal transit time
Time Frame
End of the study
Title
Small intestinal velocity
Time Frame
End of the study
Title
Changes in carcinoid symptoms and biomarkers
Time Frame
End of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
NET confirmed by histology
Diarrhea, (at least 3 loose or watery bowel movements per day) as part of carcinoid syndrome.
Newly referred patients without previous somatostatin analogue treatment or
NET patients who are pausing somatostatin analogue treatment due to other treatment or examination.
Exclusion Criteria:
Subjects unable to understand the information
Severe diabetes with late complications or known metabolic disorder
Inflammatory bowel disease
Known clinically significant stenosis of the bowel
Bile acid malabsorption due to intestinal surgery
Small bowl bacterial overgrowth
Study Population Description
We are scheduling 12 subjects (30-80 years of age) with NET and carcinoid syndrome with diarrhea. Patients are recruited through the Department of Medicine V, Aarhus University Hospital.
Sampling Method
Non-Probability Sample
Facility Information:
Facility Name
Analfysiologisk afsnit, Aarhus University Hospital, Tage Hansensgade, entrance 11A
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Gastrointestinal Motility in Patients With Neuroendocrine Tumors
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