Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors

Study Overview
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Brief Summary
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The specific aim is of this study is to gain a better understanding of the patient characteristics, treatment responses, survival outcomes, and adverse events associated with PRRT in patients with gastroenteropancreatic primary NETs.

Detailed Description
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Neuroendocrine tumors (NETs) make up a large range of malignancies that arise from neuroendocrine cells in multiple organs of the body. Hallet et al conducted a large population-based study that demonstrated that 21% of NET patients presented with metastatic disease and another 38% developed metastases after resection of the primary tumor (Hallet et al., 2015). This burden demonstrates the need for effective systemic therapy for advanced NETs. Options for systemic therapy include peptide receptor radionuclide therapy (PRRT). A need for more prospective series are needed on treatment responses and survival outcomes related to gastroenteropancreatic primary NETs treated with PRRT was identified. Thus the purpose of this study is to collect clinical data related to treatment of gastroenteropancreatic primary NETs s with PRRT. Clinical data related to patient characteristics, treatment responses and survival outcomes related to the treatment of gastroenteropancreatic primary NETs with PRRT and on adverse events and complications related to PRRT treatment will be collected.

Official Title
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Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Procedure: Peptide Receptor Radionuclide Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years of age Diagnosed with gastroenteropancreatic primary NET and has consented to undergo PRRT per the treating physician. Specifically: Will consider other primaries on a case by case basis if dotatate scan (+) and meet all other criteria. Metastatic or Locally Advanced AND Inoperable Clear disease progression on Octreotide over less than 3 years (RECIST 1.1) Presence of disease within 24 weeks as identified by PET/CT scans with Ga-68 DOTATATE reporting the Krenning score for low-grade NET and/or PET/CT scans with FDG for transformation to high-grade NET Well differentiated on path - Ki67 < 20% Octreotide positive on pathology (if not documented, acceptable if PET/CT imaging shows lesions with Ga-68 DOTATATE uptakeLabs: Cr. <1.7 Hgb >8 WBC >2K Plt >75K Bili < 3x normal limit No Octreotide within 30 days of administration. Willing and able to comply with the protocol requirements Able to comprehend and sign the Informed Consent Form in English. Exclusion Criteria: Do not meet the Study Inclusion Criteria laid out in section 6.3

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated w PRRT<br>Patients who received treatment of gastroenteropancreatic primary NETs with PRRT per the treating physicians discretion. | Procedure: Peptide Receptor Radionuclide Therapy<br>* a molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine tumors or NETs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics and other patient data | (such as age at diagnosis, sex, history of smoking alcohol use and symptoms at the time of diagnosis) | 7 years from date of procedure | 
| Tumor specific data | Tumor site, tumor grade, stage, presence of tumor necrosis, number of mitoses and percentage of Ki-67 and MIB-1 positive cells (proliferative index) | 7 years from date of procedure | 
| Use of somatostatin analogs | at the time of PRRT, location, isotope used and dose of isotope for each PRRT | 7 years from date of procedure | 
| Biomarker data (chromogranin A and pancreastatin) | at the time of diagnosis, before and after the first PRRT, and after the second PRRT were also extracted | 7 years from date of procedure | 
| Diagnostic imaging findings | prior to PRRT and response after PRRT, date of progression on imaging after PRRT, and status of disease on imaging at the last follow-up were also recorded | 7 years from date of procedure | 
| Overall survival (OS) | the time from diagnosis to death of any cause. | 7 years from date of procedure | 
| Time to progression (TTP) | the time from the first PRRT until any progression on diagnostic imaging | 7 years from date of procedure | 
| Treatment responses and progression | assessed with cross-sectional imaging with either computerized tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET) or single-photon emission computed tomography (SPECT). | 7 years from date of procedure | 
| Response | any response of any magnitude | 7 years from date of procedure | 
| Disease progression | any increase in lesion sizes and/or appearance of new metastatic lesions on diagnostic imaging exams. | 7 years from date of procedure | 
| Adverse events | will be assessed by the investigator who will determine whether or not the event is related to PRRT or related to progression of disease (gastroenteropancreatic primary NET), and whether or not the event meets serious criteria. AEs related to PRRT will be recorded in the study registry. | 7 years from date of procedure |