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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
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Neuroendocrine Tumor focused on measuring Neuroendocrine tumor, Carcinoid syndrome, Motility, Transit time

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
November 11, 2008
Last Updated
October 25, 2010
Sponsor
University of Aarhus
Collaborators
Novartis, The Danish Medical Research Council
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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

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Gastrointestinal Motility in Patients With Neuroendocrine Tumors

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