NCT01633255撤回1 期
A Pilot, Open-label, Proof-of-Concept Study of the Use of [18F] Fluciclatide PET/CT Imaging in the Evaluation of Anti-AngiogenicTherapy in Renal Cancers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- To determine tumor uptake and retention of [18F] Fluciclatide before and after 1 cycle of treatment with targeted anti-angiogenic therapy in renal cell cancer.
研究概览
简要总结
Background:
- The experimental contrast agent [18]F-Fluciclatide is being tested for cancer treatment imaging studies. It is designed to show tumors in which new blood vessels are growing. Imaging studies with [18]F-Fluciclatide may help predict how well a tumor will respond to therapy that will prevent the growth of new blood vessels. Researchers will test [18]F-Fluciclatide before beginning treatment and after the first treatment cycle. Participants may also have a third scan with [18]F-Fluciclatide between 2 and 7 days after starting treatment to look for changes in blood vessel growth early after starting therapy.
Objectives:
- To test the safety and effectiveness of [18]F-Fluciclatide in predicting cancer treatment outcomes.
Eligibility:
- Individuals at least 18 years of age who will have kidney cancer treatment to stop tumor blood vessel growth.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor imaging studies and biopsies will be performed before starting the study.
- Participants will have two positron emission tomography (PET) and computed tomography (CT) scans. [18]F-Fluciclatide will be used for each scan. One scan will happen before the start of cancer treatment, and the second will happen after the first treatment cycle.
- Participants may also have an optional third PET/CT scan with [18]F-Fluciclatide. This scan will take place 2 to 7 days after beginning therapy.
- Depending on the location of the tumor, some participants may have an optional magnetic resonance imaging scan to look for changes in tumor blood flow and size. These scans will be done within 3 weeks of each [18]F-Fluciclatide PET/CT scan.
- The scans will be monitored with regular blood tests and vital signs.
- Participants will be followed for up to 1 year after the study to look for overall disease response to therapy.
详细描述
BACKGROUND:
- Fluciclatide is a small cyclic peptide containing the RGD tri-peptide, which preferentially binds with high affinity to Alpha(v)Beta(3) integrins, which are up-regulated in and may regulate angiogenesis.
- Alpha(v)Beta(3) integrins are also expressed on certain types of tumor cells, such as renal cell cancer.
- [18F] Fluciclatide (previously known as 18F-AH111585) is a new radiopharmaceutical developed for PET imaging, which targets Alpha(v)Beta(3) receptors.
- Initial and ongoing clinical studies performed in Europe and an ongoing multicenter phase 2 proof-of-concept study (which is currently open at the NIH Clinical Center); demonstrate to date that [18F] Fluciclatide is safe and well tolerated.
PRIMARY OBJECTIVE:
- To determine tumor uptake and retention of [18F] Fluciclatide before and after 1 cycle of treatment with targeted anti-angiogenic therapy in renal cell cancer.
ELIGIBILITY:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Adult subjects (greater than or equal to18 years old), with documented renal malignancy or metastatic renal cancer, with at least one tumor greater than or equal to1 cm in diameter (not within the liver), who are scheduled for treatment using an anti-angiogenic therapy agent
- •Platelet count of >100,000 times 10(6)/L, hemoglobin value of >9 g/dL, PT and an aPTT < 2 times normal limits.
- •Clinically acceptable medical history, physical examination and vital signs findings during the screening period (from <4 weeks before administration of [18F] Fluciclatide); i.e. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to
- •The subject has had no open surgical wounds in close proximity to the target lesion(s) within 10 days prior to study entry.
- •The subject has not had a needle/core biopsy of the target lesion within 10 days of PET/CT imaging.
- •The subject has not had radiation therapy to the region of the target lesion.
排除标准
- •The subject is pregnant or nursing.
- •The subject is being treated with doses of heparin or warfarin resulting in elevation of PT or aPTT >2 times normal.
- •The subject has received any anti-angiogenic agent (e.g. bevacizumab, sorafenib, sunitinib) within 60 days prior to pre-treatment (baseline) [18F] Fluciclatide PE imaging. This stipulation does not apply after the baseline [18F] Fluciclatide PET imaging.
- •The subject has any contraindication to any of the study procedures, products used or its constituents (e.g. severe claustrophobia unrelieved by oral anxiolytics).
- •The subject is unable to lie still for 75 minutes.
- •2.1.2.6 The subject is known to have a history of hyper- or hypo-coagulation syndromes resulting in prolongation of bleeding parameters. Such coagulopathies include but are not limited to Von Willebrand disease, Protein C deficiency, Protein S deficiency, Hemophilia A/B/C, Factor-V Leiden, and Bernard-Soulier syndrome.
- •The subject has undergone a surgical procedure to the target lesion within 28 days prior to baseline [18F] Fluciclatide administration OR is scheduled to undergo a surgical procedure between the baseline and post 1-cycle [18F] Fluciclatide PET/CT.
- •The subject has only bone metastasis
- •ADDITIONAL EXCLUSION CRITERIA FOR SUBJECTS UNDERGOING OPTIONAL MR:
- •Serum creatinine within 2 weeks prior to MRI greater than or equal to1.8mg/dl OR estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m(2).
- •The subject has known allergy to gadolinium
- •2.1.3.3 The subject has contraindications to MRI
- •Subjects must weigh <136 kg (weight limit for scanner table).
- •Subjects cannot have pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.
结局指标
主要结局
To determine tumor uptake and retention of [18F] Fluciclatide before and after 1 cycle of treatment with targeted anti-angiogenic therapy in renal cell cancer.
次要结局
- Safety of multiple IV admin. of agent.
- Compare DCEMRI parameters with agent PET uptake and retention.
- Compare data on agent as a PD marker and SOC imaging markers of CR.
- Compare uptake and retention of agent at baseline and at the end of cycle 1.
研究者
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