68Ga-PSMA PET/CT vs. MRI/CT vs. lymphadenectomy for the identification of lymph node metastases in locally advanced prostate cancer patients: a diagnostic test accuracy study

Department of Nuclear Medicine, Aalborg University Hospital0 个研究点开始时间: 2014年12月12日最近更新: 2017年3月13日

试验速览

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•Oral and written informed consent.
•18 years and older.
•Histological confirmed adenocarcinoma of the prostate.
•Routine bone scintigraphy without metastasis.
•Referred for lymph node staging as standard clinical practice - either concurrent with surgical removal of the prostate (radical prostatectomy) or prior to curative (radiation therapy) or palliative (hormonal) treatment.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Prior or current therapy for prostate cancer.
•History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer.
•History of allergic reactions attributed to compounds of 68Ga-PSMA radiotracer.
•Subjects unable to undergo 68Ga PSMA PET/CT imaging procedure (e.g. claustrophobia despite oral anxiolytics).
•Subjects weighing greater than 180 kilograms (weight limit for scanner table), or unable to fit within the imaging gantry.
•Subjects with any medical condition or other circumstances (e.g. claustrophobia, unable to lie still, unable to comply with study procedures etc.) that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study.
•If the patient refuses MRI or is not eligible (known with e.g. claustrophobia or other reasons as outlined in the ESUR guideline for MRI), the patient will be offered a diagnostic CT in combination with 68Ga-PSMA PET. If the patient refuses a diagnostic CT scan or allergic or ineligible for such procedure only a 68Ga-PSMA PET/low dose CT will be performed. Such patients will be assessed for secondary endpoints only.

发起方

Department of Nuclear Medicine, Aalborg University Hospital