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CompletedNCT01339780Updated Feb 28, 2014

Imaging of Prostate and Breast Cancer Bone Metastases Using Magnetic Resonance Imaging and Nuclear Medicine Techniques

An interventional study of BS, SPECT/CT, PET/CT, MRI in Bone Metastases, sponsored by Turku University Hospital. Completed at 1 site in Finland. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-02-28.

Sponsored by Turku University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Non-randomized
Ages
40 Years to 80 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Bone Metastases

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In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.

This study's enrollment of 53 is close to the median of 54 across 2,765 interventional studies indexed under Neoplasm Metastasis.

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Lead sponsor

Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Ongoing treatment for metastatic disease
  • Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)
  • Infections: Patient must not have an uncontrolled serious infection
  • Claustrophobia
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Breast Cancer

    Radiation: BS, SPECT/CT, PET/CT, MRI

  • Experimental
    Prostate Cancer

    Radiation: BS, SPECT/CT, PET/CT, MRI

Interventions

  • RadiationBS, SPECT/CT, PET/CT, MRI

    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.

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What researchers measure

Primary outcomes

  1. Number of participants with bone metastases

    Time frame: at least 6 months follow up

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Study locations

1 site
  • Turku University Hospital
    Turku, Kiinamyllynkatu 4-8 20521, Finland
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01339780
Lead sponsor
Turku University Hospital
Responsible party
Marko Seppanen (Dr., Turku University Hospital) — Principal investigator
First posted
Apr 21, 2011
Start date
Feb 2011
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Feb 28, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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