USPIO-enhanced and Diffusion-weighted MRI for the Detecti... | NCT00622973

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

NCT00622973

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Oct 12, 2011Estimated

Enrollment

130Actual

Phase

Phase 3

Conditions

Prostate Cancer
Bladder Cancer

Interventions

Imaging: diffusion-weighted MRI
Sinerem (USPIO) enhanced MRI

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Feb 13, 2008

First Submission Date that Met QC Criteria

Feb 22, 2008

First Posted Date

Feb 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2011

Last Update Posted Date

Oct 12, 2011Estimated

Name	Class
Swiss National Science Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

Conditions

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Other	Diffusion-weighted MRI	Other: Imaging: diffusion-weighted MRI
B	Other	Sinerem (USPIO)- enhanced MRI	Other: Sinerem (USPIO) enhanced MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imaging: diffusion-weighted MRI	Other	Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both.		1 year
Preoperative localization of all suspected positive nodes in accordance to the predefined regions on both sides and in comparison with histopathology.		1 year

Secondary Outcomes

Measure	Description	Time Frame
Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology.		2-3 years

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Harriet C Thoeny, MD	University Hospital Inselspital, Bern, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inselspital		Bern		3010	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19144456	Result	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.
23916692

ID	Type	Description	Link
KEK101_06
SNF320000-113512/1
SWISSMEDIC2007DR3215

ID	Term
D011471	Prostatic Neoplasms
D001749	Urinary Bladder Neoplasms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms