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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marko Seppanen, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01339780
First received: April 20, 2011
Last updated: February 26, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Number of participants with bone metastases [ Time Frame: at least 6 months follow up ]

Enrollment: 53
Study Start Date: February 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339780

Locations
Finland
Turku University Hospital
Turku, Kiinamyllynkatu 4-8, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
  More Information

No publications provided

Responsible Party: Marko Seppanen, Dr., 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: February 26, 2014
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 August 20, 2014