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Completed

NCT Number: NCT00622973

USPIO-enhanced and Diffusion-weighted MRI for the Detection of Pelvic Lymph Node Metastases

Preoperative detection of lymph node metastases in patients with prostate or bladder cancer is crucial for selection of the appropriate treatment strategy (surgery, androgen deprivation with/or without radiation therapy or chemotherapy) and thus for patient prognosis. Until now CT or MRI have been the modalities of choice for preoperative staging procedures. However, current morphological assessment of lymph nodes based on size and shape is unable to detect smaller metastases or liable to give false positive results on lymph nodes with reactive hyperplasia. We hypothesize that USPIO-enhanced MRI combined with DW-MRI will be able to detect pelvic lymph node metastases preoperatively with high sensitivity and specificity.

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Key information

Conditions

Prostate Cancer Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Inselspital

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Imaging: diffusion-weighted MRI

Other

Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases

Sinerem (USPIO) enhanced MRI

Other

USPIO (Sinerem) will be administered intravenously immediately after the first MR examination at a dose of 2.6 mg Fe/kg body weight diluted in 100 ml of saline (optimal dose according to: (9, 10)) during a period of about 30 minutes under medical supervision. Postcontrast MR imaging will be performed 24-36 hours after contrast medium injection.

Other names: SINEREM

Primary outcomes

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

    Time frame: 1 year

  2. Preoperative localization of all suspected positive nodes in accordance to the predefined regions on both sides and in comparison with histopathology.

    Time frame: 1 year

Secondary outcomes

  1. Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology.

    Time frame: 2-3 years

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Feb 25, 2008
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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