Exploratory, Prospective, Single-Arm, Open-labeled Study of [Ga68]MTP220 PET for First-in-Human Biodistribution and Efficacy in Patients With Pancreatic Cancer and Head and Neck Cancers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Biodistribution of [Ga-68]MTP220 in patients with pancreatic cancer and head and neck cancers, as measured by standardized uptake value (SUV) mean and maximum
研究概览
简要总结
The goal of this research study is to develop a diagnostic tool to help with detection and diagnosis of head and neck cancer (HNC) and pancreatic cancer (PaC). This tool is called a "targeted PET tracer", or more specifically a drug named "[Ga-68]MTP220". The U.S. Food and Drug Administration (FDA) has not yet approved this drug, so researchers are conducting this research study to see if [Ga-68]MTP220 is safe and effective at diagnosing pancreatic cancer and head and neck cancer. FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application. Participants will receive a single injection of [Ga-68]MTP220 followed by PET/CT imaging at three points after they received the drug. These study procedures will take about 2.5 hours. Participants will also receive a follow-up phone call the day after receiving the drug to talk about any side effects they experienced.
详细描述
For HNC, the overall 5-year survival rate of HNSCCs remains ∼40-50%. PaCa is the 3rd leading cause of cancer mortality in the US with its incidence expected to double by 2030. The poor survival of HNC and PaCa patients is partly due to the delayed diagnosis. Thus, early detection and diagnosis is pivotal to improve the survival. Currently, there is still an unmet clinical need for novel diagnostic technologies for early accurate detection and diagnosis of HNC and PaCa. In this exploratory first in human phase 0 trial, researchers are testing the use of a [Ga-68]MTP220 as a targeted PET tracer to explore the biodistribution, dosimetry, efficacy and safety in pancreatic and head and neck cancer patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants older than 18 years old
- •Prior biopsy showing pancreatic or head and neck malignancy
- •Participants have been newly diagnosed and not yet received definitive therapy (including surgery, radiation therapy, or systemic therapy).
- •Able and willing to provide written informed consent before any protocol-specific procedures are undertaken
- •Participants willing and able to undergo a PET/CT
排除标准
- •Participants who do not meet the above mentioned inclusion criteria
- •Participants with severe hepatic and renal dysfunction (Total bilirubin > 3 mg/dL, Albumin < 2.8 g/dL, INR > 2.3 (or prolonged PT), presence of ascites or hepatic encephalopathy (Grade III-IV) End-Stage Renal Disease (ESRD) or eGFR < 30 mL/min/1.73m², Serum creatinine > 4 mg/dL or rapidly rising, Need for dialysis (hemodialysis or peritoneal dialysis), uremic symptoms)
- •Participants < 18 years old
- •Participants who refuse to give or are unable to sign the informed consent
- •Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
- •Participants unable to withstand or undergo PET/CT
- •Pregnant or breast feeding women.
研究组 & 干预措施
[Ga-68]MTP220 PET/CT Imaging
Participants will receive an injection of 210 MBq (3.0-6.0 mCi, range 110-220 MBq with an upper limit of 220 MBq) of [Ga68]MTP220 by slow IV push. This will be followed by PET/CT imaging. One diagnostic CT scan will be performed followed by a sequential whole body PET scan (including 7 to 8 fields-of-view depending on participant height) at three points after the injection of the drug. These three points will be 20, 60 and 100 minutes after the injection. Imaging will be performed for about 1 minute per bed position. The total duration of PET data acquisition is about 20-30 minutes.
干预措施: [Ga-68]MTP220 PET/CT Scan (Drug)
结局指标
主要结局
Biodistribution of [Ga-68]MTP220 in patients with pancreatic cancer and head and neck cancers, as measured by standardized uptake value (SUV) mean and maximum
时间窗: Time it takes to do imaging study procedures, about 2.5 hours
Radiation dosimetry of [Ga-68]MTP220, as measured by dosimetry calculations performed using site software
时间窗: Time it takes to do imaging study procedures, about 2.5 hours
次要结局
- Safety of [Ga-68]MTP220, as measured by number of participants who experience adverse events (AEs)(Participants will be asked to report AEs via telephone follow-up no more than 1 day after they undergo study imaging)
- Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in blood pressure(Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes)
- Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in heart rate(Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes)
- Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in respiratory rate(Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes)
- Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in blood oxygen saturation(Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes)
- Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in electrocardiogram (ECG)(Baseline (10 minutes before dose) and at the following points after the start of they received the dose: 10 and 140 minutes)
- Efficacy of [Ga-68]MTP220 PET/CT imaging in detecting PaCa or HNC, as measured by comparison of tumor vs normal tissue uptake of [Ga-68]MTP220, compared to conventional imaging (when available)(Time it takes to do imaging study procedures, about 2.5 hours)
- Potential of [Ga-68]MTP220 PET/CT for assessing tumor response to immunotherapy in PaCa and HNC, as measured by radiotracer uptake in tumors as compared to background activity, compared to conventional imaging (when available)(Time it takes to do imaging study procedures, about 2.5 hours)
研究者
Qiubai Li
Principal Investigator
Case Comprehensive Cancer Center