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

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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

Tracking Information
First Submitted Date December 24, 2015
First Posted Date January 6, 2016
Last Update Posted Date May 5, 2017
Actual Study Start Date January 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 2, 2016)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 2, 2016)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 2, 2016)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Heterogeneity of Metastatic Neuroendocrine Tumors as Determined With 18F-dihydroxyphenylalanine-PET /CT, a Retrospective Analysis
Official Title Heterogeneity of Metastatic Neuroendocrine Tumors as Determined With 18F-dihydroxyphenylalanine-PET /CT, a Retrospective Analysis
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.

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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Neuroendocrine Tumors
Intervention Other: Metastasized intestinal NET
This is an observational study
Study Groups/Cohorts 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.
Intervention: Other: Metastasized intestinal NET
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 4, 2017)
38
Original Estimated Enrollment
 (submitted: January 2, 2016)
45
Actual Study Completion Date May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02646644
Other Study ID Numbers 201501247
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party A.M.E. Walenkamp, University Medical Center Groningen
Study Sponsor University Medical Center Groningen
Collaborators Not Provided
Investigators
Principal Investigator: A. M.E. Walenkamp, MD, PhD University Medical Center Groningen
PRS Account University Medical Center Groningen
Verification Date May 2017