Prostate Cancer Metastatic to BoneDIMABNCT03134261
Diagnostic Imaging of Bone Metastases in Prostate Cancer Patients
A study testing WB-MRI, SPECT-CT and Cholin-PET-CT in people with Prostate Cancer Metastatic to Bone, run by Herlev Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic to Bone
- What is being tested?
- WB-MRI, SPECT-CT and Cholin-PET-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Radioogy/Department of Nuclear Medicine
Herlev, 2730
Eva Dyrberg Mortensen, MD, +45 38681002, eva.dyrberg@hotmail.com
Henrik S Thomsen, Professor, +45 38681002, henrik.thomsen@regionh.dk
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Prostate Cancer Metastatic to Bone
- Being tested
- WB-MRI, SPECT-CT, Cholin-PET-CT, PSMA-PET-CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB-MRIDiagnostic test
scanning methods
SPECT-CTDiagnostic test
scanning methods
Cholin-PET-CTDiagnostic test
scanning methods
PSMA-PET-CTDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| SPECT-CT | Other | The participants will undergo two project scans: WB-MRI and SPECT-CT Receives: Diagnostic Test: WB-MRI; Diagnostic Test: SPECT-CT |
| Cholin-PET-CT | Other | The participants will undergo two project scans: WB-MRI and Cholin-PET-CT Receives: Diagnostic Test: WB-MRI; Diagnostic Test: Cholin-PET-CT |
| PSMA-PET-CT | Other | The participants will undergo two project scans: WB-MRI and PSMA-PET-CT Receives: Diagnostic Test: WB-MRI; Diagnostic Test: PSMA-PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Sensitivity and specificity
Measured: The two project scans will be performed within a maximum of 30 days from the performance of the NaF-PET-CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study startApr 2014
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Metastatic to BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Study participants will be allocated to the "ongoing project arm" at the time of enrollment.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Dyrberg Mortensen, Herlev Hospital
- Investigators
- Henrik S. Thomsen, Professor, Study director, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134261
- Sponsor's protocol ID
- DIMAB
- Acronym
- DIMAB
- Status last verified
- May 2017
- First submitted
- 25 Apr 2017
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03134261
- Acronym / sponsor ID
- DIMAB / DIMAB
- Conditions
- Prostate Cancer Metastatic to Bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Study participants will be allocated to the "ongoing project arm" at the time of enrollment.
| Arm | Type | Receives |
|---|---|---|
| SPECT-CT | Other | Diagnostic Test: WB-MRI, Diagnostic Test: SPECT-CTThe participants will undergo two project scans: WB-MRI and SPECT-CT |
| Cholin-PET-CT | Other | Diagnostic Test: WB-MRI, Diagnostic Test: Cholin-PET-CTThe participants will undergo two project scans: WB-MRI and Cholin-PET-CT |
| PSMA-PET-CT | Other | Diagnostic Test: WB-MRI, Diagnostic Test: PSMA-PET-CTThe participants will undergo two project scans: WB-MRI and PSMA-PET-CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WB-MRIscanning methods | Diagnostic test | Cholin-PET-CT, PSMA-PET-CT, SPECT-CT |
| SPECT-CTscanning methods | Diagnostic test | SPECT-CT |
| Cholin-PET-CTscanning methods | Diagnostic test | Cholin-PET-CT |
| PSMA-PET-CT | Diagnostic test | PSMA-PET-CT |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik S. Thomsen, Professor study director
Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WB-MRI, SPECT-CT and Cholin-PET-CT in people with Prostate Cancer Metastatic to Bone, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Dyrberg Mortensen, MD (+45 38681002, eva.dyrberg@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.