EUCTR2018-004310-18-NL进行中（未招募）1 期
A confirmatory, prospective, open-label, single-arm, reader-blinded multi-centre phase 3 study to assess the diagnostic accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and unenhanced MRI in reference to histopathology in newly-diagnosed prostate cancer (PCA) patients, scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND) - Prostaprogress
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1)Voluntarily given and written informed consent.
- •2)Male =18 years of age.
- •3)Histologically newly-confirmed adenocarcinoma of the prostate.
- •4)Medium to high risk for lymph node metastasis, defined by either:
- •a) PSA = 10 ng/ml or
- •b) Gleason-Score = 7 or
- •c) Stage cT2b or cT2c or T3 or T4
- •5)Patients scheduled for radical prostatectomy (RP) with extended lymph node dissection (ePLND) between Day 7 and Day 42 after Ferrotran®-enhanced MRI.
- •6)Consent to practice contraception until end of study, including female partners of childbearing potential. Effective contraceptive measures include hormonal oral, injected or implanted female contraceptives, male condom, vaginal diaphragm, cervical cap, intrauterine device.
- •7)Preoperative PSA, clinical T-stage, primary Gleason grade, secondary Gleason grade.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1)Any contraindication to MRI, as per standard criteria.
- •2)Any radiation therapy or systemic antiproliferative (chemo-, immuno, or hormonal) therapy for prostate cancer (Lupron, Taxotere, Casodex, Eulexin, Zoladex, etc.) prior to screening and until after post-surgery FUP MRI.
- •3)Known hypersensitivity to Ferrotran®or its components such as dextran.
- •4)Known hypersensitivity to other parenteral iron products.
- •5)Acute allergy including drug allergies and allergic asthma.
- •6)Evidence of iron overload or disturbances in the utilisation of iron (e.g., haemochromatosis, haemosiderosis, chronic haemolytic anaemia with frequent blood transfusions).
- •7)Presence of liver dysfunction.
- •8)Any other investigational medicinal product within 30 days prior to receiving study medication until end of study visit.
- •9)Simultaneous participation in any other clinical trial.
- •10)Abnormal safety laboratory values at screening or baseline that are assessed by the principal investigator as clinically relevant.
- •11)Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders), or other vulnerable patients (e.g. under arrest).
研究者
相似试验
进行中（未招募）
1 期
A clinical phase 3 study to assess the accuracy of Ferumoxtran-10 in Magnetic Resonance Imaging (MRI) to detect cancerous tissue in patients which are scheduled for a radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND). All patients will receive the Ferumoxtran-10 and the imaging results will be compared with the analysis of the removes tissue samples.newly-diagnosed prostate cancer (PCA)MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-004310-18-DESaving Patients' Lives Medical B.V.200
招募中
3 期
A confirmatory, prospective, open-label, single-arm, reader-blinded multi-centre phase 3 study to assess the diagnostic accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and unenhanced MRI in reference to histopathology in newly-diagnosed prostate cancer (PCA) patients, scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND)Prostate CancerNL-OMON52732Saving Patients' Lives Medical B.V. (SPL Medical)36
招募中
1 期
A clinical phase 3 study to assess the accuracy of Ferumoxtran-10 in Magnetic Resonance Imaging (MRI) to detect cancerous tissue in patients which are scheduled for a radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND). All patients will receive the Ferumoxtran-10 and the imaging results will be compared with the analysis of the removed tissue samples.newly-diagnosed prostate cancer (PCA)MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-004310-18-BESaving Patients' Lives Medical B.V.200
招募中
3 期
A Confirmatory, Prospective, Open-label, Single-arm, Reader-blinded Multi-centre Phase 3 Study to Assess the Diagnostic Accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and Unenhanced MRI in Reference to Histopathology in Newly-diagnosed Prostate Cancer (PCA) Patients, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (ePLND).metastasised lymph nodes in the pelvic regionhigh risk prostate cancerC61Malignant neoplasm of prostateDRKS00019106Saving Patients' Lives Medical B.V. (SPL Medical)200
进行中（未招募）
1 期
A study to evaluate the safety and potential therapeutic benefit of use of clazosentan in reversing cerebral vasospasm (a narrowing of blood vessels in the brain) in patients who have suffered a condition known as aneurysmal subarachnoid hemorrhage caused by bleeding onto the surface of the brain from a ruptured brain aneurysmcerebral vasospasmAneurysmal subarachnoid hemorrhage (aSAH)MedDRA version: 19.1Level: LLTClassification code 10047164Term: Vasospasm cerebralSystem Organ Class: 100000004852MedDRA version: 19.1Level: LLTClassification code 10042320Term: Subarachnoid hemorrhageSystem Organ Class: 100000004863EUCTR2015-002721-18-FIActelion Pharmaceuticals Ltd25