Safety & Efficacy of 68Ga-DOTA-tyr3-Octreotide PET/CT in Diagnosis, Staging & Measurement of Response to Treatment in Patients With Somatostatin Receptor Positive Tumors: Comparison to Octreoscan Plus High-Resolution, Contrast Enhanced CT.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- To Measure Safety of 68Ga-DOTATOC Positron Emission Tomography (PET) by Measuring the Number of Adverse Events Related to the Investigational Radiopharmaceutical Agent
研究概览
简要总结
This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.
详细描述
This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. The goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.
Project Design
68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors is a prospective, Phase 1-2, single center, open-label study in subjects with known or suspected somatostatin receptor positive tumor. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study with an option to receive a second 68Ga-DOTATOC PET/CT if they begin a new treatment (surgery, hepatic embolization, Sandostatin LAR, chemotherapy, targeted biological therapy, or peptide receptor radiotherapy) within 30 days of the first scan. The second scan will be performed at a time recommended by the treating physician as optimal interval to observe results from treatment.
Project Goal
This study is planned to demonstrate the safety and efficacy of [68Ga]-DOTA-tyr3-Octreotide ([68Ga]-DOTATOC) as an accurate imaging technique for diagnosis, staging, and monitoring of response to treatment in patients with Somatostatin receptor expressing tumors.
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
盲法说明
The Octreoscan and 68Ga-DOTA-tyr3-Octreotide PET scans are read independently by two certified nuclear medicine physicians for discordant positive lesions.
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age greater than or equal to 2 years
- •Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; medulloblastoma; pheochromocytoma. Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.
- •Karnofsky performance status or Lansky Play Scale status of greater than 50 (or ECOG/WHO equivalent)
- •Subject is male; or is a female who is either pre-menarchal, surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), non-lactating, or of childbearing potential for whom a serum pregnancy test (with the results known prior to investigational product administration) is negative. A negative serum 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 capable of becoming pregnant.
排除标准
- •Subject weighs more than 400 pounds (Subjects who weigh more than 400 pounds will not be able to fit inside the imaging machines).
- •Inability to lie still for the entire imaging time (e.g. 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.)
- •Does the subject have any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance?
研究组 & 干预措施
68Ga-DOTATOC PET/CT
68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors
干预措施: 68Ga-DOTATOC PET/CT (Drug)
结局指标
主要结局
To Measure Safety of 68Ga-DOTATOC Positron Emission Tomography (PET) by Measuring the Number of Adverse Events Related to the Investigational Radiopharmaceutical Agent
时间窗: During PET scan and 24 hours post scan
Subject receives an injection of 68Ga-DOTATOC, a somatostatin-like peptide that binds to somatostatin receptor and is tagged with a radionuclide that can be detected by positron emission tomography (PET). Whole body PET is performed; patient is queried regarding any adverse events immediately and again 24 hrs after completion of scan read by certified nuclear medicine physician to determine if any known tumor lesions take up 68Ga-DOTATOC.Severity of adverse events will be graded according to NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Adverse events are assessed immediately after PET scan and 24 hrs after completion of the scan.
Number of Subjects With Adverse Events Related to the Use of the 68Ga-DOTATOC
时间窗: Up to 6 months
Number of subjects with adverse events related to the use of the 68Ga-DOTATOC radiopharmaceutical in accordance with National Cancer Institute (NCI) toxicity guidelines (NCI Common Terminology Criteria for Adverse Events version 4.0)
次要结局
未报告次要终点
研究者
Sue O'Dorisio
Professor of Medicine
University of Iowa