Prostate CancerPhase 3NCT00622973
USPIO-enhanced and Diffusion-weighted MRI for the Detection of Pelvic Lymph Node Metastases
A Phase 3 study testing Imaging: diffusion-weighted MRI and Sinerem (USPIO) enhanced MRI in people with Prostate Cancer and Bladder Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Prostate Cancer, Bladder Cancer
- What is being tested?
- Imaging: diffusion-weighted MRI and Sinerem (USPIO) enhanced MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2007to Mar 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Prostate Cancer, Bladder Cancer
- Being tested
- Imaging: diffusion-weighted MRI, Sinerem (USPIO) enhanced MRI
- 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
- Medical subject headings
- Prostatic Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging: diffusion-weighted MRIOther
Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases
Sinerem (USPIO) enhanced MRIOther
Also called SINEREM
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Diffusion-weighted MRI Receives: Other: Imaging: diffusion-weighted MRI |
| B | Other | Sinerem (USPIO)- enhanced MRI Receives: Other: Sinerem (USPIO) enhanced MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both.
Measured: 1 year
Preoperative localization of all suspected positive nodes in accordance to the predefined regions on both sides and in comparison with histopathology.
Measured: 1 year
Secondary outcomes (1)
Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology.
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Investigators
- Harriet C Thoeny, MD, Principal investigator, University Hospital Inselspital, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622973
- Sponsor's protocol ID
- SNF320000-113512/1
- Other IDs
- KEK101_06, SNF320000-113512/1, SWISSMEDIC2007DR3215
- Status last verified
- Oct 2011
- First submitted
- 13 Feb 2008
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19144456Birkhauser 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.
PubMed 23916692Triantafyllou 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.
PubMed 23084842
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00622973
- Acronym / sponsor ID
- SNF320000-113512/1
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Sep 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Other: Imaging: diffusion-weighted MRIDiffusion-weighted MRI |
| B | Other | Other: Sinerem (USPIO) enhanced MRISinerem (USPIO)- enhanced MRI |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging: diffusion-weighted MRIDiffusion-weighted MRI of the entire pelvis to detect lymph node metastases | Other | A |
| Sinerem (USPIO) enhanced MRIAlso: SINEREMUSPIO (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 | B |
Primary outcome
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
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
1 secondary outcome
Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology.
Time frame: 2-3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
- Results publication: PubMed 19144456Thoeny 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.
- Derived from this study: PubMed 23916692Birkhauser 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.
- Derived from this study: PubMed 23084842Triantafyllou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harriet C Thoeny, MD principal investigator
University Hospital Inselspital, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imaging: diffusion-weighted MRI and Sinerem (USPIO) enhanced MRI in people with Prostate Cancer and Bladder Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00622973, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.