Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 2730 for:    Neoplasms | Neuroendocrine Tumors

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02646644
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
A.M.E. Walenkamp, University Medical Center Groningen

Brief Summary:

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.


Condition or disease Intervention/treatment
Neuroendocrine Tumors Other: Metastasized intestinal NET

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Heterogeneity of Metastatic Neuroendocrine Tumors as Determined With 18F-dihydroxyphenylalanine-PET /CT, a Retrospective Analysis
Actual Study Start Date : January 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646644


Locations
Layout table for location information
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Layout table for investigator information
Principal Investigator: A. M.E. Walenkamp, MD, PhD University Medical Center Groningen

Layout table for additonal information
Responsible Party: A.M.E. Walenkamp, Principal Investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02646644     History of Changes
Other Study ID Numbers: 201501247
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs