Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Biomarker data (chromogranin A and pancreastatin)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 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
- •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.
排除标准
- •Do not meet the Study Inclusion Criteria laid out in section 6.3
结局指标
主要结局
Biomarker data (chromogranin A and pancreastatin)
时间窗: 7 years from date of procedure
at the time of diagnosis, before and after the first PRRT, and after the second PRRT were also extracted
Demographics and other patient data
时间窗: 7 years from date of procedure
(such as age at diagnosis, sex, history of smoking alcohol use and symptoms at the time of diagnosis)
Use of somatostatin analogs
时间窗: 7 years from date of procedure
at the time of PRRT, location, isotope used and dose of isotope for each PRRT
Diagnostic imaging findings
时间窗: 7 years from date of procedure
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
Time to progression (TTP)
时间窗: 7 years from date of procedure
the time from the first PRRT until any progression on diagnostic imaging
Overall survival (OS)
时间窗: 7 years from date of procedure
the time from diagnosis to death of any cause.
Tumor specific data
时间窗: 7 years from date of procedure
Tumor site, tumor grade, stage, presence of tumor necrosis, number of mitoses and percentage of Ki-67 and MIB-1 positive cells (proliferative index)
Response
时间窗: 7 years from date of procedure
any response of any magnitude
Disease progression
时间窗: 7 years from date of procedure
any increase in lesion sizes and/or appearance of new metastatic lesions on diagnostic imaging exams.
Adverse events
时间窗: 7 years from date of procedure
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.
Treatment responses and progression
时间窗: 7 years from date of procedure
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).
次要结局
未报告次要终点