Safety and Efficacy of Ga-68-IAC Positron Emission Tomography (PET/CT) for Diagnosis and Clinical Management in Metastatic Breast Cancer Patients.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Specific Aims 2:To evaluate biodistribution and dosimetry of Ga-68-IAC
研究概览
简要总结
This is a phase I/IIa, open label, multicenter interventional study of Gallium-68 radiolabeled Integrin Adhesion Complex antagonist conjugate (Ga-68-IAC) Positron Emission Tomography (PET/CT) imaging, intended for diagnosis, and clinical management of patients with Metastatic breast cancer.
详细描述
This is a prospective non blinded trial, Phase I/IIa, multicenter, study in a total of up to 25 subjects with angiogenic therapy indication for breast cancer. All patients with confirmed diagnoses will undergo [18F]Fluoro-deoxyglucose (18F-FDG) PET/CT (6-12 mCi) and Ga-68-IAC PET/CT 2-5 mCi to evaluate safety, biodistribution, and response to treatment in metastatic breast 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with solid tumors (either 3+ by immunohistochemistry or with evidence of gene amplification (>2.0) by fluorescence in situ hybridization (FISH))
- •At least 18 years of age
- •Able to provide informed consent.
- •Karnofsky score greater than 50
- •Females of childbearing potential must have a negative pregnancy test at screening/baseline
- •AIP-301 Ga-68 positive scan define by SUV greater than
- •Adequate organ function, defined as:
- •Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
- •Hemoglobin (Hb) ≥9 g/dl (transfusion or use of EPO is permitted).
- •Platelets > 100,000/mm3
- •Creatinine ≤ 1.5 x normal value based on the Cock Gault (CG) equation.
- •AST or ALT ≤ 2.5 x ULN (or ≤5 x ULN in case of liver metastasis)
- •Alkaline phosphatase ≤2.5 x ULN. Alkaline phosphatase may be more than 2.5 x ULN only in the case of bone metastases, and AST and ALT less than 1.5 x ULN.
- •Total bilirubin ≤1.5 mg/dl (higher bilirubin levels are permitted if the patient has Gilbert's syndrome).
- •Baseline LVEF ≥50% measured using echocardiogram or equilibrium
- •isotopic ventriculography (MUGA).
排除标准
- •• Serum creatinine >3.0 mg/dL (270 μM/L)
- •Hepatic enzyme levels more than 5 times upper limit of normal.
- •Known severe allergy or hypersensitivity to IV radiographic contrast.
- •Use of any other investigational product or device within 30 days prior to dosing or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
- •Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.
- •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.)
- •Recognized concurrent active infection (e.g., HIV)
- •Previous Grade 3 or higher allergic reaction to Trastuzumab that resulted in discontinuation of Trastuzumab therapy. Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
- •Adult patients who require monitored anesthesia for PET scanning
结局指标
主要结局
Specific Aims 2:To evaluate biodistribution and dosimetry of Ga-68-IAC
时间窗: 6 Months
Assess drug safety and tolerability measuring incidence of abnormal vital signs. Vital signs will include measurements of respiratory rate, pulse rate, and systolic and diastolic blood pressure.
Specific Aims 3: To determine the recommended phase 2 dose (RP2D) of Ga-68-IAC examination
时间窗: 6 Months
Assess drug safety and tolerability measuring incidence of abnormal physical examination findings. Physical examination will be summarized for each body system such as head, eyes, ears, nose, and throat, and cardiovascular, dermatological, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurological systems.
Specific Aims 1:To evaluate the safety, toxicity profile and tolerability of Ga-68-IAC in patients diagnosed with angiogenic breast cancer.
时间窗: 6 Months
Assess drug safety and tolerability measuring Incidence of adverse events. NCI Common Terminology Criteria for Adverse Events v5.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening
次要结局
- Specific Aim 1: To determine the pharmacokinetic and pharmacodynamic profile of Ga-68-IAC(6 Months)