Accuracy of Lymph Node Imaging in Prostate Cancer: PSMA PET-CT and Nano-MRI (MAGNIFY)

July 19, 2017 updated by: Radboud University Medical Center

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Eindhoven, Netherlands
        • Recruiting
        • Catharina Ziekenhuis Eindhoven
        • Contact:
          • Eric Vrijhof, PhD
      • Nijmegen, Netherlands, 6532 SZ
        • Recruiting
        • Canisius Wilhelmina Ziekenhuis
        • Contact:
          • Jean-Paul van Basten, PhD
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500HB
        • Recruiting
        • Radboud University Medical Centre
        • Contact:
        • Principal Investigator:
          • Fred Witjes, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PSMA PET-CT and USPIO MRI
Diagnostic test: Ferumoxtran-10 enhanced MRI; MRI contrast agent
Patient undergo MRI with an USPIO contrast agent
Diagnostic test: 68Ga PSMA PET-CT
Patient undergo an 68Ga PSMA PET-CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 8 weeks before pelvic lymph node dissection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Astellas Pharma Inc
Catharina Ziekenhuis Eindhoven
Canisius-Wilhelmina Hospital

Investigators

  • Principal Investigator: Fred Witjes, PhD, Radboud University Medical Centre Nijmegen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2016

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

July 18, 2017

First Submitted That Met QC Criteria

July 18, 2017

First Posted (Actual)

July 19, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 19, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASTELLAS/MAGNIFY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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