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

Primary Purpose

Prostate Cancer Metastatic to Bone

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
WB-MRI
SPECT-CT
Cholin-PET-CT
PSMA-PET-CT
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer Metastatic to Bone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Radioogy/Department of Nuclear MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

SPECT-CT

Cholin-PET-CT

PSMA-PET-CT

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Diagnostic accuracy
Sensitivity and specificity

Secondary Outcome Measures

Full Information

First Posted
April 25, 2017
Last Updated
May 2, 2017
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03134261
Brief Title
Diagnostic Imaging of Bone Metastases in Prostate Cancer Patients
Acronym
DIMAB
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (Actual)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Metastatic to Bone

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Study participants will be allocated to the "ongoing project arm" at the time of enrollment.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPECT-CT
Arm Type
Other
Arm Description
The participants will undergo two project scans: WB-MRI and SPECT-CT
Arm Title
Cholin-PET-CT
Arm Type
Other
Arm Description
The participants will undergo two project scans: WB-MRI and Cholin-PET-CT
Arm Title
PSMA-PET-CT
Arm Type
Other
Arm Description
The participants will undergo two project scans: WB-MRI and PSMA-PET-CT
Intervention Type
Diagnostic Test
Intervention Name(s)
WB-MRI
Intervention Description
scanning methods
Intervention Type
Diagnostic Test
Intervention Name(s)
SPECT-CT
Intervention Description
scanning methods
Intervention Type
Diagnostic Test
Intervention Name(s)
Cholin-PET-CT
Intervention Description
scanning methods
Intervention Type
Diagnostic Test
Intervention Name(s)
PSMA-PET-CT
Primary Outcome Measure Information:
Title
Diagnostic accuracy
Description
Sensitivity and specificity
Time Frame
The two project scans will be performed within a maximum of 30 days from the performance of the NaF-PET-CT scan

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only males can get prostate cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Dyrberg Mortensen, MD
Phone
+45 38681002
Email
eva.dyrberg@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik S. Thomsen, Professor
Phone
+45 38683212
Email
henrik.thomsen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik S. Thomsen, Professor
Organizational Affiliation
Department of Radiology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Radioogy/Department of Nuclear Medicine
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Dyrberg Mortensen, MD
Phone
+45 38681002
Email
eva.dyrberg@hotmail.com
First Name & Middle Initial & Last Name & Degree
Henrik S Thomsen, Professor
Phone
+45 38681002
Email
henrik.thomsen@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diagnostic Imaging of Bone Metastases in Prostate Cancer Patients

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