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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FDG-PET | Radiation | Fludeoxyglucose F18 | ||
| 68Ga-DOTATOC-PET | Radiation | DOTA-tyr3-Octreotide Ga68 | ||
| Computed tomography | Radiation | Computed tomography of thorax and abdomen with 3-phase contrast | ||
| Core needle biopsy | Other | Core needle biopsy of metastatic lesions | ||
| Phlebotomy | Other | Phlebotomy from peripheral vein |
| Measure | Description | Time Frame |
|---|---|---|
| Protocol adherence | 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. | Study inclusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of core needle biopsy: NCI Common Terminology Criteria | Defined as a NCI Common Terminology Criteria for Adverse Events 4.03 grade 3-4 adverse event related to the procedure. | At study inclusion and within 48 hours of the procedure |
Inclusion Criteria:
Exclusion Criteria:
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Pancreatic Neuroendocrine Tumors
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joakim Crona, MD, PhD | Contact | 0046186110000 | joakim.crona@medsci.uu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akademiska Sjukhuset | Recruiting | Uppsala | 75185 | Sweden |
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| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D062005 | Biopsy, Large-Core Needle |
| D018962 | Phlebotomy |
| ID | Term |
|---|---|
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
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| D010190 |
| Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D011677 | Punctures |
| D008919 | Investigative Techniques |
| D001800 | Blood Specimen Collection |
| D013812 | Therapeutics |