NCT03741517

Biomarker Study of Pancreatic Neuroendocrine Tumours

Prospective Longitudinal Observation Trial of Clinical and Molecular Features of Pancreatic Neuroendocrine Tumours

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The biology of pancreatic neuroendocrine tumors can change during the disease course. This evolution of disease can manifest through increases in tumor proliferation rate, resistance to medical therapy and/or a change in tumor hormone secretion. This study aims to characterize how the biology of pancreatic neuroendocrine tumors change over time, measured by; patient symptoms, biochemistry, contrast enhanced computed tomography, DOTATOC-PET, FDG-PET and core needle biopsy with histopathological analysis (Ki67 index and tumor cell differentiation). Uptake on 68Ga-DOTATOC and 18F-FDG-PET will be correlated directly to tumor cell proliferation rate. Fraction of patients with spatial heterogeneity in DOTATOC as well as FDG uptake as well as metachronous changes in all collected data will be documented. Biomaterial from whole blood and core needle biopsies will be characterized on the molecular level, and those findings will be integrated to the above specified clinical parameters.

Conditions

• Pancreatic Neuroendocrine Tumor

Interventions

Type	Name	Description
RADIATION	18F-FDG-PET	Fludeoxyglucose F18
RADIATION	68Ga-DOTATOC-PET	DOTA-tyr3-Octreotide Ga68
RADIATION	Computed tomography	Computed tomography of thorax and abdomen with 3-phase contrast
OTHER	Core needle biopsy	Core needle biopsy of metastatic lesions
OTHER	Phlebotomy	Phlebotomy from peripheral vein

Timeline

• Start date: 2019-01-30
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2018-11-15
• Last updated: 2022-05-18

Locations

1 site across 1 country: Sweden