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

NCT02646644 | Completed

• 1 other identifier: 201501247
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• tracer uptake in tumor lesions within patients with intestinal NET

  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 Outcomes (1)

• tracer uptake in tumor lesions within patients with intestinal NET adjusted for uptake of background organ

  at the day of scan

Other Outcomes (1)

• the correlation of the magnitude of heterogeneity with ki 67

  date of diagnosis until date of scan

Study Arms (1)

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

Interventions

Metastasized intestinal NET OTHER

This is an observational study

Metastasized intestinal NET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• A. M.E. Walenkamp, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: January 6, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)