Biomarker Study of Pancreatic Neuroendocrine Tumours

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03741517

Enrollment

Registered

2018-11-15

Start date

2019-01-30

Completion date

2024-12-31

Last updated

2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neuroendocrine Tumor

Brief 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.

Interventions

RADIATION18F-FDG-PET

Fludeoxyglucose F18

RADIATION68Ga-DOTATOC-PET

DOTA-tyr3-Octreotide Ga68

RADIATIONComputed tomography

Computed tomography of thorax and abdomen with 3-phase contrast

OTHERCore needle biopsy

Core needle biopsy of metastatic lesions

OTHERPhlebotomy

Phlebotomy from peripheral vein

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥18 years * Informed consent * Pathology confirmed diagnosis of pancreatic neuroendocrine tumor WHO grade 1-3 or neuroendocrine carcinoma grade 3.

Exclusion criteria

* Patient does not consent * Pregnancy or no contraceptive in fertile women.

Design outcomes

Primary

Measure	Time frame	Description
Protocol adherence	Study inclusion	Defined as the proportion of patients where that following investigations are performed: Core needle biopsy, FDG-PET, DOTATOC-PET, research blood samples, pancreatic hormones and hormonal syndromes.

Other

Measure	Time frame	Description
Safety of core needle biopsy: NCI Common Terminology Criteria	At study inclusion and within 48 hours of the procedure	Defined as a NCI Common Terminology Criteria for Adverse Events 4.03 grade 3-4 adverse event related to the procedure.

Countries

Sweden

Contacts

Primary ContactJoakim Crona, MD, PhD

joakim.crona@medsci.uu.se0046186110000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026