Bone MetastasesNCT01339780
Imaging of Prostate and Breast Cancer Bone Metastases Using Magnetic Resonance Imaging and Nuclear Medicine Techniques
A study testing BS, SPECT/CT, PET/CT, MRI in people with Bone Metastases, run by Turku University Hospital at 1 site in Finland.
Trial summary
Prostate and breast cancer continues to be the most common cancer among men and women, respectively. The exact assessment of the cancer spread with detection of possible bone metastasis is crucial for treatment decision. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Bone Metastases
- What is being tested?
- BS, SPECT/CT, PET/CT, MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2011to Jan 2014
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 40 to 80 years
- Language spoken: Finnish or Swedish
- Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
- Diagnosis: Histologically confirmed prostate or breast cancer
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff
- strong suspicion of first bone metastatic disease (already diagnosed metastases in other organs, elevated tumor markers, destruction of bone in plain x-ray or otherwise specified reasons
- adjuvant chemo- or endocrine therapy is allowed
Who cannot join
- Ongoing treatment for metastatic disease
- Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)
- Infections: Patient must not have an uncontrolled serious infection
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Prostate and breast cancer continues to be the most common cancer among men and women, respectively. The exact assessment of the cancer spread with detection of possible bone metastasis is crucial for treatment decision. In the current study 50 patients with prostate cancer and 50 patients with breast cancer at high risk for bone metastases or with know metastatic disease will be studied with multiple imaging modalities. Patients will be recruited from the Department of Oncology, Turku University Hospital. Planar bone scintigraphy (BS), single photon emission computed tomography combined with low-dose computed tomography (SPECT/CT), 18F-fluoride positron emission tomography computed tomography (PET/CT) and magnetic resonance imaging (MRI) will be performed to all patients. The primary objective is to determine the diagnostic accuracy of the four imaging modalities. The secondary goal is to calculate the sensitivities and specificities of the four imaging modalities on a patient-to-patient and lesion-to-lesion basis. Based on the results of this study an optimal imaging protocol for detection of prostate and breast cancer bone metastasis will be developed and validated.
- Conditions
- Bone Metastases
- Being tested
- BS, SPECT/CT, PET/CT, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BS, SPECT/CT, PET/CT, MRIRadiation
Planar bone scintigraphy (BS), single photon emission computed tomography combined with low-dose computed tomography (SPECT/CT), 18F-fluoride positron emission tomography computed tomography (PET/CT) and magnetic resonance imaging (MRI) will be performed to all patients.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer | Experimental | Not described Receives: Radiation: BS, SPECT/CT, PET/CT, MRI |
| Prostate Cancer | Experimental | Not described Receives: Radiation: BS, SPECT/CT, PET/CT, MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with bone metastases
Measured: at least 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marko Seppanen, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339780
- Sponsor's protocol ID
- 113/180/2010
- Status last verified
- Feb 2014
- First submitted
- 20 Apr 2011
- Last updated
- 28 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Prostate and Breast Cancer Bone Metastases Using Magnetic Resonance Imaging and Nuclear Medicine Techniques
- ClinicalTrials.gov ID
- NCT01339780
- Acronym / sponsor ID
- 113/180/2010
- Conditions
- Bone Metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Feb 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 Apr 2011 (estimated)
- 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.
Prostate and breast cancer continues to be the most common cancer among men and women, respectively. The exact assessment of the cancer spread with detection of possible bone metastasis is crucial for treatment decision. In the current study 50 patients with prostate cancer and 50 patients with breast cancer at high risk for bone metastases or with know metastatic disease will be studied with multiple imaging modalities. Patients will be recruited from the Department of Oncology, Turku University Hospital. Planar bone scintigraphy (BS), single photon emission computed tomography combined with low-dose computed tomography (SPECT/CT), 18F-fluoride positron emission tomography computed tomography (PET/CT) and magnetic resonance imaging (MRI) will be performed to all patients. The primary objective is to determine the diagnostic accuracy of the four imaging modalities. The secondary goal is to calculate the sensitivities and specificities of the four imaging modalities on a patient-to-patient and lesion-to-lesion basis. Based on the results of this study an optimal imaging protocol for detection of prostate and breast cancer bone metastasis will be developed and validated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | Experimental | Radiation: BS, SPECT/CT, PET/CT, MRI |
| Prostate Cancer | Experimental | Radiation: BS, SPECT/CT, PET/CT, MRI |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 40 to 80 years
- Language spoken: Finnish or Swedish
- Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
- Diagnosis: Histologically confirmed prostate or breast cancer
- Mental status: Patients must be able to understand the meaning of the study
Key exclusion criteria (4 listed)
- Ongoing treatment for metastatic disease
- Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)
- Infections: Patient must not have an uncontrolled serious infection
- Claustrophobia
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 |
|---|---|---|
| BS, SPECT/CT, PET/CT, MRIPlanar bone scintigraphy (BS), single photon emission computed tomography combined with low-dose computed tomography (SPECT/CT), 18F-fluoride positron emission tomography computed tomography (PET/CT) and magnetic resonance imaging (MRI) will be performed to all patients. | Radiation | Breast Cancer, Prostate Cancer |
Primary outcome
Number of participants with bone metastases
Time frame: at least 6 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BS, SPECT/CT, PET/CT, MRI in people with Bone Metastases, run by Turku University Hospital at 1 site in Finland.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 28 Feb 2014. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with bone metastases (time frame: at least 6 months follow up). 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 28 Feb 2014.