Accuracy of Lymph Node Imaging in Prostate Cancer: PSMA PET-CT and Nano-MRI (MAGNIFY)
Primary Purpose
Prostate Cancer, Lymph Node Metastases
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Ferumoxtran-10 enhanced MRI; MRI contrast agent
68Ga PSMA PET-CT
Sponsored by
![Radboud University Medical Center](https://trials-media.s3.amazonaws.com/orgs/radboud-university-medical-center.jpeg)
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Sites / Locations
- Radboud University Medical CentreRecruiting
- Catharina Ziekenhuis EindhovenRecruiting
- Canisius Wilhelmina ZiekenhuisRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PSMA PET-CT and USPIO MRI
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03223064
First Posted
July 18, 2017
Last Updated
July 19, 2017
Sponsor
Radboud University Medical Center
Collaborators
Astellas Pharma Inc, Canisius-Wilhelmina Hospital, Catharina Ziekenhuis Eindhoven
1. Study Identification
Unique Protocol Identification Number
NCT03223064
Brief Title
Accuracy of Lymph Node Imaging in Prostate Cancer: PSMA PET-CT and Nano-MRI
Acronym
MAGNIFY
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Astellas Pharma Inc, Canisius-Wilhelmina Hospital, Catharina Ziekenhuis Eindhoven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Lymph Node Metastases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PSMA PET-CT and USPIO MRI
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Ferumoxtran-10 enhanced MRI; MRI contrast agent
Intervention Description
Patient undergo MRI with an USPIO contrast agent
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga PSMA PET-CT
Intervention Description
Patient undergo an 68Ga PSMA PET-CT scan
Primary Outcome Measure Information:
Title
Concordance between and sensitivity and specificity of PSMA PET-CT and USPIO enhanced MRI
Description
The sensitivity and specificity of the PSMA PET-CT and nano-MRI will be determined based upon pathological validation
Time Frame
Within 8 weeks before pelvic lymph node dissection
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bart Philips, MSc
Email
Bart.Philips@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Witjes, PhD
Organizational Affiliation
Radboud University Medical Centre Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bart Philips
Email
Bart.Philips@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Fred Witjes, PhD
Facility Name
Catharina Ziekenhuis Eindhoven
City
Eindhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Vrijhof, PhD
Facility Name
Canisius Wilhelmina Ziekenhuis
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Paul van Basten, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Accuracy of Lymph Node Imaging in Prostate Cancer: PSMA PET-CT and Nano-MRI
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