NL-OMON45969
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Prostate cancer
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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 pelvic lymph node dissection, as per institutional guidelines and not yet treated for prostate cancer;\- Subject is willing to sign and date the study Informed Consent form;\- Signed, written informed consent
Exclusion Criteria
- •\- Previous treatment for prostate cancer (surgery, radiotherapy, chemotherapy, hormone androgen deprivation therapy);\- Proven metastatic disease;\- Patients who refuse 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 meets the exclusion criteria required by local law
Outcomes
Primary Outcomes
Not specified
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