Accuracy of lymph node imaging in prostate cancer: A prospective cohort study to determine the concordance between two imaging modalities, Combidex” magnetic resonance imaging (Nano MRI) and 68Ga-PSMA positron emission tomography (PET). - MAGNIFI

Radboudumc0 个研究点目标入组 80 人开始时间: 2016年3月7日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•- Male, aged 18 years (or older, if required by local law)
•- Prostate cancer present (Gleason = 7) and/or PSA = 15 and/or Clinical or radiological Stage T3
•- Suspected lymph node involvement pre-prostatectomy
•- Suitable for radical prostatectomy and pelvic lymph node dissection, as per institutional guidelines and not yet treated pre-prostatectomy
•- Subject is willing to sign and date the study Informed Consent form
•- Signed, written informed consent
•- Subject is expected to remain available for 24 months of clinic visits
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•- Previous treatment for prostate cancer (surgery, radiotherapy, chemotherapy, hormone androgen deprivation therapy)
•- Proven metastatic disease
•- Patients who refuse prostatectomy or pelvic lymph node dissection
•- Patients who refuse to join the trial or are unable to consent
•- Patients not being considered for further therapy
•- Contra-indication to MRI scanning, IV iron infusion, allergy to dextran or other injectable contrast media used in this trial
•- Patients who cannot lie still for at least 30 minutes or comply with imaging
•- Unequivocal evidence of disease outside the pelvis on conventional imaging
•- Subject has medical conditions that would limit study participation (per physician discretion)
•- Subject has hemochromatosis and liver disease
•- Subject has known allergy against Fe-products or dextranes
•- Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by the study investigators
•- Subject has a limited life expectancy that would not allow completion of the 24 month visits
•- Subject meets the exclusion criteria required by local law

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