Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Number of Participants With a Change in Treatment Management Based on Findings of the Gallium Ga 68-edotreotide PET/CT Scan
研究概览
简要总结
Participants in this study have been diagnosed with a tumor such as a carcinoid, neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which carry somatostatin receptors.
The purpose of this research study is to see if the tumor can be identified using a special procedure called a positron emission tomography (PET) scan and how the results of this imaging procedure will change the management of the tumor.
详细描述
This is a prospective, Phase II, single center, open-label study in a total of 200 participants with histologically proven neuroendocrine tumor or other somatostatin receptor positive tumors. Eligible participants will undergo baseline assessments at enrollment. They will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Participants may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age ≥ 6 months
- •Histologically diagnosed neuroendocrine tumor or other tumor with probable somatostatin receptors subtype 2
- •Karnofsky performance status or Lansky Play Scale status of ≥ 60 (or ECOG/WHO equivalent)
- •Subject is male; or is a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), ≥60 years old,or of childbearing potential for whom a pregnancy test (with the results known prior to investigational product administration) is negative. A negative pregnancy test will be required for all female subjects with child bearing potential. If a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is not capable of becoming pregnant. Female must also be non-lactating.
排除标准
- •Subject weighs more than 450 pounds. (Subjects who weigh more than 450 pounds will not be able to fit inside the imaging machines) or otherwise cannot be safely fit into the imaging system.
- •Inability to lie still for the entire imaging time (due to cough, severe arthritis, etc.)
- •Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- •Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
- •Peptide receptor radionuclide therapy (PRRT) within 4 weeks of Ga-68 DOTATOC PET/CT scan.
- •Treatment with Sandostatin LAR within 4 weeks, SQ Octreotide within 12 hours, or Lanreotide injection within 8 weeks of Ga-68 DOTATOC PET/CT (+/-5%).
研究组 & 干预措施
68Ga-DOTATOC PET/CT
Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.
干预措施: 68Ga-DOTATOC PET/CT (Drug)
结局指标
主要结局
Number of Participants With a Change in Treatment Management Based on Findings of the Gallium Ga 68-edotreotide PET/CT Scan
时间窗: 36 months
Referring physicians will be asked to fill out pre-PET and post-PET scan forms to provide information on the management and treatment strategy of the patient before the PET-CT scan and after the information from the PET-CT study is available. This is the same methodology used in the National Oncologic PET Registry study; change in management strategy criteria are modified for the specific treatment strategies used in NET.
次要结局
未报告次要终点
研究者
Sue O'Dorisio
Professor, Pediatrics Hematology/Oncology
University of Iowa