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Noninvasive Detection of Clinically Occult Lymph Node Metastases in Prostate and Bladder Cancer Evaluated by USPIO-Enhanced MRI and Diffusion-Weighted MRI: A Histopathological Correlation


Phase 3
18 Years
90 Years
Not Enrolling
Both
Prostate Cancer, Bladder Cancer

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Trial Information

Noninvasive Detection of Clinically Occult Lymph Node Metastases in Prostate and Bladder Cancer Evaluated by USPIO-Enhanced MRI and Diffusion-Weighted MRI: A Histopathological Correlation


Inclusion Criteria:



- Patients with histologically proven prostate cancer (T1-2N0M0 Gleason score 6-10)
scheduled for radical prostatectomy or patients with histologically proven bladder
cancer (T1-3bN0M0G3) scheduled for cystectomy

- Written informed consent to participate in this trial.

Exclusion Criteria:

- Patients with contraindications for MRI (e.g. pacemaker, metal implants,
claustrophobia).

- Patients in a critical cardiovascular state, with risk of decompensation after
administration of the USPIO contrast agent.

- Patients with hemochromatosis or an allergy to dextran or iron compounds.

- Pregnant or breast-feeding women.

- Patients who have received gadolinium complexes within 2 days or iron oxide particles
within 7 days before MRI.

- Patients who underwent chemotherapy or radiotherapy before surgery.

- Patients whose degree of cooperation is incompatible with carrying out the study.

- Patients with contraindications to Glucagon administration.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Harriet C Thoeny, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Inselspital, Bern, Switzerland

Authority:

Switzerland: Swissmedic

Study ID:

SNF320000-113512/1

NCT ID:

NCT00622973

Start Date:

September 2007

Completion Date:

March 2011

Related Keywords:

  • Prostate Cancer
  • Bladder Cancer
  • Prostate cancer
  • Bladder cancer
  • Pelvic lymph node metastases
  • Diffusion-weighted MRI
  • Sinerem (USPIO)-enhanced MRI
  • Imaging influence on surgery
  • Noninvasive detection of pelvic lymph node metastases
  • Influence of imaging protocol on surgical outcome
  • Urinary Bladder Neoplasms
  • Body Weight
  • Neoplasm Metastasis
  • Prostatic Neoplasms

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