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Diagnostic Imaging of Bone Metastases in Prostate Cancer Patients (DIMAB)

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ClinicalTrials.gov Identifier: NCT03134261
Recruitment Status : Unknown
Verified May 2017 by Eva Dyrberg Mortensen, Herlev Hospital.
Recruitment status was:  Recruiting
First Posted : April 28, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Eva Dyrberg Mortensen, Herlev Hospital

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic to Bone Diagnostic Test: WB-MRI Diagnostic Test: SPECT-CT Diagnostic Test: Cholin-PET-CT Diagnostic Test: PSMA-PET-CT Not Applicable

Detailed Description:

The project is a prospective diagnostic test accuracy study. The project takes place at Herlev Hospital and is a collaboration between the Department of Radiology and the Department of Clinical Physiology and Nuclear Medicine.

The investigators want to include 300 prostate cancer patients referred to our standard diagnostic imaging (NaF-PET-CT scan) by the clinicians.

In addition to the standard diagnostic imaging (NaF-PET-CT-scan), two project will be performed on all participants. The project has three arms with the following scanning combinations:

A) Whole-body MRI + SPECT-CT B) Whole-body MRI + Cholin-PET-CT C) Whole-body MRI + PSMA-PET-CT The recruitment of project participants takes place on the day when the patients are undergoing a NaF-PET-CT scan in the course of regular clinical practice at our institution.

All readers are experienced radiologists or specialists in nuclear medicine. Patient identification on each scan will be anonymized and the reader will not have access to clinical and biochemical information or previous imaging studies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Study participants will be allocated to the "ongoing project arm" at the time of enrollment.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Study Comparing the Diagnostic Accuracy of Bone SPECT-CT, Choline-PET-CT, PSMA-PET-CT, NaF-PET-CT and WB-MRI in the Detection of Prostate Cancer Bone Metastases
Actual Study Start Date : April 2014
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
SPECT-CT
The participants will undergo two project scans: WB-MRI and SPECT-CT
Diagnostic Test: WB-MRI
scanning methods

Diagnostic Test: SPECT-CT
scanning methods

Cholin-PET-CT
The participants will undergo two project scans: WB-MRI and Cholin-PET-CT
Diagnostic Test: WB-MRI
scanning methods

Diagnostic Test: Cholin-PET-CT
scanning methods

PSMA-PET-CT
The participants will undergo two project scans: WB-MRI and PSMA-PET-CT
Diagnostic Test: WB-MRI
scanning methods

Diagnostic Test: PSMA-PET-CT



Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: The two project scans will be performed within a maximum of 30 days from the performance of the NaF-PET-CT scan ]
    Sensitivity and specificity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only males can get prostate cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 pacemaker or implanted devices (eg. cardiac valves, neurostimulator or insulin pump) that cannot be removed, metal clips/metal prostheses from surgery that are not MRI compatible or metallic foreign bodies in the eye (MRI exclusion criteria)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134261


Contacts
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Contact: Eva Dyrberg Mortensen, MD +45 38681002 eva.dyrberg@regionh.dk
Contact: Henrik S. Thomsen, Professor +45 38683212 henrik.thomsen@regionh.dk

Locations
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Denmark
Department of Radioogy/Department of Nuclear Medicine Recruiting
Herlev, Denmark, 2730
Contact: Eva Dyrberg Mortensen, MD    +45 38681002    eva.dyrberg@hotmail.com   
Contact: Henrik S Thomsen, Professor    +45 38681002    henrik.thomsen@regionh.dk   
Sponsors and Collaborators
Herlev Hospital
Investigators
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Study Director: Henrik S. Thomsen, Professor Department of Radiology
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Responsible Party: Eva Dyrberg Mortensen, MD, Phd-student, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03134261    
Other Study ID Numbers: DIMAB
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases