Imaging of Prostate and Breast Cancer Bone Metastases Using Magnetic Resonance Imaging and Nuclear Medicine Techniques
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bone Metastases |
Radiation: BS, SPECT/CT, PET/CT, MRI |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Breast Cancer |
Radiation: BS, 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.
|
| Experimental: Prostate Cancer |
Radiation: BS, 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.
|
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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:
- Ongoing treatment for metastatic disease
- Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)
- Infections: Patient must not have an uncontrolled serious infection
- Claustrophobia
Contacts and Locations| Contact: Marko Seppänen, MD | +35820000 | Marko.Seppanen@tyks.fi |
| Finland | |
| Turku University Hospital | Recruiting |
| Turku, Kiinamyllynkatu 4-8, Finland, 20521 | |
| Contact: Marko Seppänen 035820000 marko.seppanen@tyks.fi | |
| Sub-Investigator: Hannu Aronen | |
| Sub-Investigator: Seppo Pyrhönen | |
| Sub-Investigator: Riikka Huovinen | |
| Sub-Investigator: Marjaana Luukkaa | |
| Sub-Investigator: Jukka Kemppainen | |
| Sub-Investigator: Kirsti Dean | |
More Information
No publications provided
| Responsible Party: | Marko Seppänen, Turku University Hospital |
| ClinicalTrials.gov Identifier: | NCT01339780 History of Changes |
| Other Study ID Numbers: | 113/180/2010 |
| Study First Received: | April 20, 2011 |
| Last Updated: | November 10, 2011 |
| Health Authority: | Finland: Ethics Committee |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Neoplasms |
Pathologic Processes Neoplasms by Site Bone Diseases Musculoskeletal Diseases Hematologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013