Heterogeneity of Metastatic Neuroendocrine Tumors as Determined With 18F-dihydroxyphenylalanine-PET /CT, a Retrospective Analysis (HET-NET)

May 4, 2017 updated by: A.M.E. Walenkamp, University Medical Center Groningen

In an individual cancer patient extensive genetic and phenotypic variation exists between and within tumor lesions. Tumour load in NET patients can be measured with fluorine-18-L-dihydroxyphenylalaninepositron emission tomography (18F-DOPA-PET) scan.

This aim of the study is to investigate heterogeneity between tumor lesions within patients with intestinal NET by determining the differences in tracer uptake measured on a 18F- DOPA-PET scan retrospectively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In an individual cancer patient extensive genetic and phenotypic variation exists between and within tumor lesions. Tumour load in NET patients can be measured with fluorine-18-L-dihydroxyphenylalanine positron emission tomography (18F-DOPA-PET) scan.

This aim of the study is to investigate heterogeneity between tumor lesions within patients with intestinal NET by determining the differences in tracer uptake measured on a 18F- DOPA-PET scan in retrospect.

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We will select the 18F- DOPA-PET scans conducted in the UMCG of adult patients with a metastasized intestinal NET between February 2014 until November 2015. Only patients of whose clinical data are available within the UMCG are included.

Description

Inclusion Criteria:

  • age ≥18 years
  • diagnosis of intestinal NET diagnosed by a dedicated NET specialist
  • more than one positive lesion on the 18F-DOPA-PET scan.
  • available CT-scan within 6 months before or after the 18F-DOPA-PET-scan.

Exclusion Criteria:

  • no clinical data available at the UMCG, besides the results of the DOPA PET scan.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Metastasized intestinal NET
We will select the 18F- DOPA-PET scans conducted in the Universtiy Medical Center of Groningen (UMCG) of adult patients with a metastasized intestinal NET between February 2014 until November 2015. Only patients of whose clinical data are available within the UMCG are included.
Other: Metastasized intestinal NET
This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tracer uptake in tumor lesions within patients with intestinal NET
Time Frame: at the day of scan
The difference in tracer uptake of tumor lesions within patients with intestinal NET measured on a 18F- DOPA-PET scan.
at the day of scan

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tracer uptake in tumor lesions within patients with intestinal NET adjusted for uptake of background organ
Time Frame: at the day of scan
The difference in tracer uptake of tumor lesions adjusted for uptake of background organ within patients with intestinal NET measured on a 18F- DOPA-PET scan.
at the day of scan

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
the correlation of the magnitude of heterogeneity with ki 67
Time Frame: date of diagnosis until date of scan
the correlation of the magnitude of heterogeneity between tumor lesions within patients with Intestinal NET, with the ki67 index of the tumor
date of diagnosis until date of scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: A. M.E. Walenkamp, MD, PhD, University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

December 24, 2015

First Submitted That Met QC Criteria

January 2, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201501247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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