A Non-Randomised Phase II Study to Evaluate the Optimal Uptake Time of 68GA-OPS202 as a sstr2 Positive PET Imaging Agent in Subjects With Newly Diagnosed Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With Sufficiently Avid Lesion(s) Identified as a sstr2 Positive Lesion (Co-Primary Endpoint)
研究概览
简要总结
The purpose of this clinical research is to define the optimal uptake time of 68Ga-OPS202 as a PET imaging agent to be used to detect and localize breast cancer somatostatin receptor subtype 2 (SSTR2) positive lesions.
68Ga-OPS202 is a radiolabelled imaging agent to be used in association with PET. 68Ga-OPS202 is made of two main components: 1) OPS202, an antagonistic somatostatin analogue which binds to the somatostatin receptor (type 2) present on the surface of the tumor cells and 2) Gallium 68, a radioisotope that, combined with OPS202, can be seen in the PET scanner.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years or older
- •Subjects with newly diagnosed (early or advanced) breast cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •Adequate bone marrow, liver and renal function, with:
- •Calculated glomerular filtration rate (GFR): ≥45 mL/min
- •Albumin: >30 g/L
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): ≤5 times upper limit of normal (ULN)
- •Bilirubin: ≤3xULN (3×1.1 mg/dL)
- •Leukocytes: ≥3x109/L, and neutrophils: ≥1x109/L
- •Erythrocytes: ≥3.5x1012/L
- •Platelets: ≥90x109/L
- •Signed written informed consent prior to any study-related procedures.
排除标准
- •Subject with resected primary tumour
- •Subjects with confirmed ductal carcinoma in situ
- •Men with breast cancer
- •Presence of an active infection at screening or history of a serious infection within the previous 6 weeks prior to the first 68Ga-OPS202 administration that might interfere with the PET and/or CT analysis
- •Subjects who have received any therapy for breast cancer
- •Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
- •Clinically relevant trauma within 2 weeks prior to first 68Ga-OPS202 administration
- •Any condition that precludes the proper performance of PET and/or CT scan:
- •Subjects who are not able to tolerate the CT contrast agent
- •Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis
- •Subjects unable to raise arms for prolonged imaging purposes
- •Subjects unable to lie still for the entire imaging time
- •Subjects weighing greater than 110 kg (243 lb)
- •Known hypersensitivity to radiolabelled NODAGA (1,4,7- triazacyclononane,1-glutaric acid 4,7 acetic acid), to Gallium-68, to somatostatin analogue peptide JR11 or to any of the excipients of 68Ga- OPS202
- •History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of systemic corticosteroids
- •Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B or C
- •Administration of another investigational medicinal product within 30 days prior to first 68Ga-OPS202 administration
- •Subjects who are pregnant, breast feeding or of childbearing potential not willing to practice effective contraceptive techniques during the study treatment period and for 30 days after the last dose of 68Ga-OPS202 administration; pregnancy test must be performed at the start of the study and prior to 68Ga-OPS202 administration
- •Subjects who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including any mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude
- •Subject who experienced a previous cancer (except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus), and/or subjects treated with curative intent and free from disease for more than 5 years
研究组 & 干预措施
68Ga-OPS202
A single dose of Satoreotide trizoxetan will be administered as a slow intravenous (i.v.) bolus injected over 1 minute at Baseline/Day 1.
干预措施: Satoreotide trizoxetan (Drug)
结局指标
主要结局
Percentage of Subjects With Sufficiently Avid Lesion(s) Identified as a sstr2 Positive Lesion (Co-Primary Endpoint)
时间窗: At 0.5, 1.0 and 2.0 hours post injection on Day 1.
The percentage of subjects with sufficiently avid lesion(s) to be identified as a sstr2 positive lesion using 68Ga-satoreotide trizoxetan was to be determined.
Differences in the Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Between the 3 PET Acquisition Timepoints in Primary Breast Lesions (Co-Primary Endpoint)
时间窗: 0.5, 1.0 and 2.0 hours post injection on Day 1
The differences in the number of lesions detected by 68Ga-satoreotide trizoxetan between the 3 PET acquisition timepoints, and reader interpretation was to be determined.
次要结局
未报告次要终点