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 sites80 target enrollmentMarch 7, 2016

Overview

No summary available.

Registry

who.int

Start Date

March 7, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•\- 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

•\- 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