Gastrointestinal Motility in Patients With Neuroendocrine Tumors

NCT00789841 | Completed

• 1 other identifier: M-20080121
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumor

Keywords

Neuroendocrine tumor; Carcinoid syndrome; Motility; Transit time

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal transit time in NET patients

  End of the study

Secondary Outcomes (4)

• Gastric emptying in NET patients

  End of the study

• Small intestinal transit time

  End of the study

• Small intestinal velocity

  End of the study

• Changes in carcinoid symptoms and biomarkers

  End of the study

Study Arms (1)

Patients with NET and diarrhea.

Device: Magnetic Tracking System (MTS) and radio-opaque markers

Interventions

Magnetic Tracking System (MTS) and radio-opaque markers DEVICE

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.

Patients with NET and diarrhea.

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Novartis: collaborator
• The Danish Medical Research Council: collaborator

Study Sites (1)

Analfysiologisk afsnit, Aarhus University Hospital, Tage Hansensgade, entrance 11A

Aarhus, Aarhus, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples wich are destroyed after analysis

MeSH Terms

Conditions

Neuroendocrine Tumors; Serotonin Syndrome

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 11, 2008
• First Posted: November 13, 2008
• Study Start: September 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 26, 2010

Record last verified: 2010-10

Locations

DK (1)