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

Bone Metastases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339780
• Other study ID #: 113/180/2010
• Status: Completed
• Phase: N/A
• First received: April 20, 2011
• Last updated: February 26, 2014
• Start date: February 2011
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku	Kiinamyllynkatu 4-8

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with bone metastases		at least 6 months follow up