Prostate CancerMAGNIFYNCT03223064
Accuracy of Lymph Node Imaging in Prostate Cancer: PSMA PET-CT and Nano-MRI
A study testing Ferumoxtran-10 enhanced MRI; MRI contrast agent and 68Ga PSMA PET-CT in people with Prostate Cancer and Lymph Node Metastases, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial summary
Following curative intended therapy in prostate cancer patients, a high proportion of patients (approx. 25%) relapse with local and/or distant recurrence. The metastasis of a lymph node (LN) in a patient with prostate cancer means that the disease has become systemic with the increased risk of disease progression. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Lymph Node Metastases
- What is being tested?
- Ferumoxtran-10 enhanced MRI; MRI contrast agent and 68Ga PSMA PET-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesNetherlands
- Study dates
- 30 Dec 2016to 31 Dec 2017
- Phase
- Interventional
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male, aged 18 years Prostate cancer present (Gleason ≥ 7) and/or
- PSA ≥ 15 and/or
- Clinical or radiological Stage T3
- Subject will be undergoing a pelvic lymph node dissection as part of the prostate cancer treatment.
- Subject is willing to sign and date the study Informed Consent form
- Signed, written informed consent
Who cannot join
- Patients who cannot lie still for at least 30 minutes or comply with imaging
- Subject has medical conditions that would limit study participation (per physician discretion)
- Subject has hemochromatosis and liver disease
- Subject has known allergy against Fe-products or dextranes
- Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by the study investigators
- Previous treatment for prostate cancer (surgery, radiotherapy, chemotherapy, hormone androgen deprivation therapy)
Show all 9Show fewer
- Proven bony metastatic disease, visceral metastases or lymph node metastases above the level of the aortic bifurcation
- Patients who will not get prostatectomy or pelvic lymph node dissection for any reason
- Patient has absolute contra-indications to undergoing MRI scanning
Trial locations and contacts
3 sites in 1 country.
Bart Philips, MSc contact
Netherlands3 sites, 3 recruiting
- Recruiting
Catharina Ziekenhuis Eindhoven
Eindhoven
Eric Vrijhof, PhD
- Recruiting
Radboud University Medical Centre
Nijmegen, Gelderland, 6500HB
Bart Philips, Bart.Philips@radboudumc.nl
Fred Witjes, PhD
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen, 6532 SZ
Jean-Paul van Basten, PhD
About this study
Official title: Accuracy of Lymph Node Imaging in Prostate Cancer: A Prospective Cohort Study to Determine the Concordance Between Two Imaging Modalities, "Combidex" Magnetic Resonance Imaging (Nano MRI) and 68Ga-PSMA Positron Emission Tomography (PET)
Following curative intended therapy in prostate cancer patients, a high proportion of patients (approx. 25%) relapse with local and/or distant recurrence. The metastasis of a lymph node (LN) in a patient with prostate cancer means that the disease has become systemic with the increased risk of disease progression. Therefore the ability to detect the presence of LN metastasis is important in terms of disease prognosis and treatment options. In the past, patients with LN metastasis have had poor prognoses due to the scarcity of accurate staging techniques and toxic treatment regimens such as radiotherapy. For those patients with a medium to high risk of having LN metastasis, the current procedure is a bilateral pelvic lymph node dissection (PLND). This is the standard procedure prior to curative treatment with either radical prostatectomy or radiation therapy. However, the procedure is not optimal due to the frequent inability to remove all positive lymph nodes within the dissection area. 41% of metastatic LN disease is not found, due to these LN being outside the routine surgery field. As a result, some urologists will perform an extended lymphadenectomy (e-PLND), which leads to extended operating times and the risk of complications. Also, therapy of LN metastases has limitations: more than 50% of metastatic LN are outside the routine (RTOG-CTV) radiation field. Thus the effect of standard LN radiotherapy is limited. Currently used imaging techniques such as CT and conventional MRI are also not sensitive enough to detect prostate cancer metastases due to the small size of the nodes (< 8mm).
In this study, patients that undergo a pelvic lymph node dissection will be undergoing a 68Ga PSMA PET-CT and a nano-MRI prior to surgery. The results of the PSMA PET-CT and the nano-MRI will be validated using the pathology results of the (PLND).
- Conditions
- Prostate Cancer, Lymph Node Metastases
- Being tested
- Ferumoxtran-10 enhanced MRI; MRI contrast agent, 68Ga PSMA PET-CT
- Medical subject headings
- Prostatic Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferumoxtran-10 enhanced MRI; MRI contrast agentDiagnostic test
Patient undergo MRI with an USPIO contrast agent
68Ga PSMA PET-CTDiagnostic test
Patient undergo an 68Ga PSMA PET-CT scan
| Study group | Role | What they receive |
|---|---|---|
| PSMA PET-CT and USPIO MRI | Experimental | Not described Receives: Diagnostic Test: Ferumoxtran-10 enhanced MRI; MRI contrast agent; Diagnostic Test: 68Ga PSMA PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between and sensitivity and specificity of PSMA PET-CT and USPIO enhanced MRI
The sensitivity and specificity of the PSMA PET-CT and nano-MRI will be determined based upon pathological validation
Measured: Within 8 weeks before pelvic lymph node dissection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start30 Dec 2016
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc, Canisius-Wilhelmina Hospital, Catharina Ziekenhuis Eindhoven
- Responsible party
- Sponsor
- Investigators
- Fred Witjes, PhD, Principal investigator, Radboud University Medical Centre Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223064
- Sponsor's protocol ID
- ASTELLAS/MAGNIFY
- Acronym
- MAGNIFY
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Lymph Node Imaging in Prostate Cancer: A Prospective Cohort Study to Determine the Concordance Between Two Imaging Modalities, "Combidex" Magnetic Resonance Imaging (Nano MRI) and 68Ga-PSMA Positron Emission Tomography (PET)
- ClinicalTrials.gov ID
- NCT03223064
- Acronym / sponsor ID
- MAGNIFY / ASTELLAS/MAGNIFY
- Conditions
- Prostate Cancer, Lymph Node Metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc, Canisius-Wilhelmina Hospital, Catharina Ziekenhuis Eindhoven
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 19 Jul 2017 (actual)
- 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.
Following curative intended therapy in prostate cancer patients, a high proportion of patients (approx. 25%) relapse with local and/or distant recurrence. The metastasis of a lymph node (LN) in a patient with prostate cancer means that the disease has become systemic with the increased risk of disease progression. Therefore the ability to detect the presence of LN metastasis is important in terms of disease prognosis and treatment options. In the past, patients with LN metastasis have had poor prognoses due to the scarcity of accurate staging techniques and toxic treatment regimens such as radiotherapy. For those patients with a medium to high risk of having LN metastasis, the current procedure is a bilateral pelvic lymph node dissection (PLND). This is the standard procedure prior to curative treatment with either radical prostatectomy or radiation therapy. However, the procedure is not optimal due to the frequent inability to remove all positive lymph nodes within the dissection area. 41% of metastatic LN disease is not found, due to these LN being outside the routine surgery field. As a result, some urologists will perform an extended lymphadenectomy (e-PLND), which leads to extended operating times and the risk of complications. Also, therapy of LN metastases has limitations: more than 50% of metastatic LN are outside the routine (RTOG-CTV) radiation field. Thus the effect of standard LN radiotherapy is limited. Currently used imaging techniques such as CT and conventional MRI are also not sensitive enough to detect prostate cancer metastases due to the small size of the nodes (< 8mm).
In this study, patients that undergo a pelvic lymph node dissection will be undergoing a 68Ga PSMA PET-CT and a nano-MRI prior to surgery. The results of the PSMA PET-CT and the nano-MRI will be validated using the pathology results of the (PLND).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSMA PET-CT and USPIO MRI | Experimental | Diagnostic Test: Ferumoxtran-10 enhanced MRI; MRI contrast agent, Diagnostic Test: 68Ga PSMA PET-CT |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male, aged 18 years Prostate cancer present (Gleason ≥ 7) and/or
- PSA ≥ 15 and/or
- Clinical or radiological Stage T3
- Subject will be undergoing a pelvic lymph node dissection as part of the prostate cancer treatment.
- Subject is willing to sign and date the study Informed Consent form
Key exclusion criteria (9 listed)
- Patients who cannot lie still for at least 30 minutes or comply with imaging
- Subject has medical conditions that would limit study participation (per physician discretion)
- Subject has hemochromatosis and liver disease
- Subject has known allergy against Fe-products or dextranes
- Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by the study investigators
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 |
|---|---|---|
| Ferumoxtran-10 enhanced MRI; MRI contrast agentPatient undergo MRI with an USPIO contrast agent | Diagnostic test | PSMA PET-CT and USPIO MRI |
| 68Ga PSMA PET-CTPatient undergo an 68Ga PSMA PET-CT scan | Diagnostic test | PSMA PET-CT and USPIO MRI |
Primary outcome
Concordance between and sensitivity and specificity of PSMA PET-CT and USPIO enhanced MRI
Time frame: Within 8 weeks before pelvic lymph node dissection
The sensitivity and specificity of the PSMA PET-CT and nano-MRI will be determined based upon pathological validation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Bart Philips, MSc contact
Fred Witjes, PhD principal investigator
Radboud University Medical Centre Nijmegen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferumoxtran-10 enhanced MRI; MRI contrast agent and 68Ga PSMA PET-CT in people with Prostate Cancer and Lymph Node Metastases, run by Radboud University Medical Center at 3 sites in Netherlands.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bart Philips, MSc (Bart.Philips@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between and sensitivity and specificity of PSMA PET-CT and USPIO enhanced MRI (time frame: Within 8 weeks before pelvic lymph node dissection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2017; AzTrials last refreshed its copy on 6 Nov 2026.