NCT03134261

Brief Summary

An improved diagnosis of bone metastases in prostate cancer patients can have a significant impact on treatment strategy and probably survival as well. The primary purpose of the project is to determine the diagnostic accuracy of bone SPECT-CT, choline-PET-CT, PSMA-PET-CT, NaF-PET-CT and Whole-body MRI in the diagnosis of bone metastases in prostate cancer patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 1, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

4 years

First QC Date

April 25, 2017

Last Update Submit

May 2, 2017

Conditions

Prostate Cancer Metastatic to Bone

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    Sensitivity and specificity

    The two project scans will be performed within a maximum of 30 days from the performance of the NaF-PET-CT scan

Study Arms (3)

SPECT-CT

OTHER

The participants will undergo two project scans: WB-MRI and SPECT-CT

Diagnostic Test: WB-MRIDiagnostic Test: SPECT-CT

Cholin-PET-CT

OTHER

The participants will undergo two project scans: WB-MRI and Cholin-PET-CT

Diagnostic Test: WB-MRIDiagnostic Test: Cholin-PET-CT

PSMA-PET-CT

OTHER

The participants will undergo two project scans: WB-MRI and PSMA-PET-CT

Diagnostic Test: WB-MRIDiagnostic Test: PSMA-PET-CT

Interventions

WB-MRIDIAGNOSTIC_TEST

scanning methods

Cholin-PET-CTPSMA-PET-CTSPECT-CT
SPECT-CTDIAGNOSTIC_TEST

scanning methods

SPECT-CT
Cholin-PET-CTDIAGNOSTIC_TEST

scanning methods

Cholin-PET-CT
PSMA-PET-CTDIAGNOSTIC_TEST
PSMA-PET-CT

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly males can get prostate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A subject will be eligible for project participation if he meets all of the following criteria:
  • Is either 1) a newly diagnosed prostate cancer patient in clinical suspicion of bone metastases or 2) a previously diagnosed prostate cancer patient in clinical suspicion of progression in the form of bone metastases. The subject must have been referred to the standard diagnostic imaging (18F-NaF-PET-CT) at our institution for bone metastases.
  • The prostate cancer diagnosis must be biopsy-proven
  • The subject is willing and able to comply with the protocol as judged by the investigator

You may not qualify if:

  • A subject will be excluded from the protocol if he meets one or more of the following criteria:
  • Has prior malignancy, except for adequately treated basal cell or squamous cell skin cancer
  • Has any condition that places the subject at an unacceptable risk if he undergoes a diagnostic CT-scan (e.g. history of severe allergic reaction to the contrast agent).
  • Has severe obesity (\>195 kg is the weight limit for the scanner table)
  • Has severe claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radioogy/Department of Nuclear Medicine

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Interventions

Single Photon Emission Computed Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-PhotonTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Henrik S. Thomsen, Professor

    Department of Radiology

    STUDY DIRECTOR

Central Study Contacts

Eva Dyrberg Mortensen, MD

CONTACT

+45 38681002eva.dyrberg@regionh.dk

Henrik S. Thomsen, Professor

CONTACT

+45 38683212henrik.thomsen@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: Study participants will be allocated to the "ongoing project arm" at the time of enrollment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Phd-student

Study Record Dates

First Submitted

April 25, 2017

First Posted

April 28, 2017

Study Start

April 1, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)