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

NCT ID: NCT00622973

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Bladder Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

Diffusion-weighted MRI

Group Type OTHER

Imaging: diffusion-weighted MRI

Intervention Type OTHER

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

B

Sinerem (USPIO)- enhanced MRI

Group Type OTHER

Sinerem (USPIO) enhanced MRI

Intervention Type 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.

Interventions

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Imaging: diffusion-weighted MRI

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

Intervention Type OTHER

Sinerem (USPIO) enhanced MRI

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.

Intervention Type OTHER

Other Intervention Names

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SINEREM

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Inselspital, Berne

Principal Investigators

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Harriet C Thoeny, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Inselspital, Bern, Switzerland

Locations

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Inselspital

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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Thoeny HC, Triantafyllou M, Birkhaeuser FD, Froehlich JM, Tshering DW, Binser T, Fleischmann A, Vermathen P, Studer UE. Combined ultrasmall superparamagnetic particles of iron oxide-enhanced and diffusion-weighted magnetic resonance imaging reliably detect pelvic lymph node metastases in normal-sized nodes of bladder and prostate cancer patients. Eur Urol. 2009 Apr;55(4):761-9. doi: 10.1016/j.eururo.2008.12.034. Epub 2009 Jan 7.

Reference Type RESULT
PMID: 19144456 (View on PubMed)

Birkhauser FD, Studer UE, Froehlich JM, Triantafyllou M, Bains LJ, Petralia G, Vermathen P, Fleischmann A, Thoeny HC. Combined ultrasmall superparamagnetic particles of iron oxide-enhanced and diffusion-weighted magnetic resonance imaging facilitates detection of metastases in normal-sized pelvic lymph nodes of patients with bladder and prostate cancer. Eur Urol. 2013 Dec;64(6):953-60. doi: 10.1016/j.eururo.2013.07.032. Epub 2013 Jul 30.

Reference Type DERIVED
PMID: 23916692 (View on PubMed)

Triantafyllou M, Studer UE, Birkhauser FD, Fleischmann A, Bains LJ, Petralia G, Christe A, Froehlich JM, Thoeny HC. Ultrasmall superparamagnetic particles of iron oxide allow for the detection of metastases in normal sized pelvic lymph nodes of patients with bladder and/or prostate cancer. Eur J Cancer. 2013 Feb;49(3):616-24. doi: 10.1016/j.ejca.2012.09.034. Epub 2012 Oct 18.

Reference Type DERIVED
PMID: 23084842 (View on PubMed)

Other Identifiers

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KEK101_06

Identifier Type: -

Identifier Source: secondary_id

SNF320000-113512/1

Identifier Type: -

Identifier Source: secondary_id

SWISSMEDIC2007DR3215

Identifier Type: -

Identifier Source: secondary_id

SNF320000-113512/1

Identifier Type: -

Identifier Source: org_study_id