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

Primary Purpose

Prostate Cancer, Bladder Cancer

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Imaging: diffusion-weighted MRI
Sinerem (USPIO) enhanced MRI
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring 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

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Inselspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A

B

Arm Description

Diffusion-weighted MRI

Sinerem (USPIO)- enhanced MRI

Outcomes

Primary Outcome Measures

Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both.
Preoperative localization of all suspected positive nodes in accordance to the predefined regions on both sides and in comparison with histopathology.

Secondary Outcome Measures

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

Full Information

First Posted
February 13, 2008
Last Updated
October 7, 2011
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00622973
Brief Title
USPIO-enhanced and Diffusion-weighted MRI for the Detection of Pelvic Lymph Node Metastases
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Bladder Cancer
Keywords
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
Diffusion-weighted MRI
Arm Title
B
Arm Type
Other
Arm Description
Sinerem (USPIO)- enhanced MRI
Intervention Type
Other
Intervention Name(s)
Imaging: diffusion-weighted MRI
Intervention Description
Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases
Intervention Type
Other
Intervention Name(s)
Sinerem (USPIO) enhanced MRI
Other Intervention Name(s)
SINEREM
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology.
Time Frame
2-3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harriet C Thoeny, MD
Organizational Affiliation
University Hospital Inselspital, Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19144456
Citation
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.
Results Reference
result
PubMed Identifier
23916692
Citation
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.
Results Reference
derived
PubMed Identifier
23084842
Citation
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.
Results Reference
derived

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

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