NCT01993160

Brief Summary

This is a single centre, single arm feasibility study of 18FCH PET-MR imaging for staging patients with high risk prostate cancer. Study Hypothesis: FCH-PET/MR will enable more accurate staging of patients with high risk prostate cancer as compared to conventional imaging.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

October 25, 2013

Last Update Submit

January 12, 2017

Conditions

Prostate Cancer

Keywords

Fluorocholine (FCH)Positron emission tomography (PET)Magnetic resonance imaging (MRI)

Outcome Measures

Primary Outcomes (1)

  • Number of prostate cancer foci detected with FCH PET/MR compared to MR alone.

    2 years

Secondary Outcomes (1)

  • Detection rate of lymph node and distant metastases in patients with high risk prostate cancer as compared to conventional imaging strategies (CT abdomen and bone scintigraphy).

    2 years

Other Outcomes (2)

  • Overall accuracy of multiparametric mapping of choline metabolism with various MR parameters in staging of patients with high risk prostate cancer as compared to conventional imaging strategies.

    2 years

  • Relationship of choline kinase activity in the primary tumor (as expressed by FCH uptake) to presence of hypoxia and expression of GLUT-1 transporter proteins in pathology specimens.

    2 years

Study Arms (1)

18F-FCH PET MR

EXPERIMENTAL

Integrated whole body PET-MR or PET-CT and separate whole body MRI with use of 18F-FCH as the molecular probe

Drug: Fluorocholine (18F-FCH) InjectionRadiation: PET scanRadiation: Whole body MRI

Interventions

Fluorocholine (18F-FCH) InjectionDRUG

Before the PET-CT scan, the tracer (fluorocholine/FCH) will be injected into a vein in your arm just before the scan. This is the agent we are investigating in this study (not part of the standard procedure)

18F-FCH PET MR
PET scanRADIATION

A whole body PET scan will be performed, integrated with either whole body low dose CT or whole body MRI

18F-FCH PET MR
Whole body MRIRADIATION

A whole body MRI scan will be performed. This may be integrated with PET scan or performed separately.

18F-FCH PET MR

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Histologic diagnosis of carcinoma of prostate
  • High risk disease: defined as Gleason ≥8, or T3 disease, or PSA \>20ng/mL
  • No prior therapy for prostate cancer (surgery, radiation therapy, hormone therapy, chemotherapy).
  • Ability to provide written informed consent to participate in the study

You may not qualify if:

  • Prior surgery or radiation therapy for prostate cancer
  • Prior or ongoing hormone or other systemic therapy for prostate cancer
  • Inability to lie supine for 90 minutes
  • Any contraindication to MR as per Joint Department of Medical Imaging policies.
  • Impaired kidney function with glomerular filtration rate \< 30ml/min
  • Previous anaphylactic reaction to gadolinium or other contraindications to MR.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre, University Health Network, 610 University Ave.

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluorocholineInjectionsMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Ur Metser, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2013

First Posted

November 25, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations

CA(1)