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

Not Applicable

Completed

• Conditions: Bone Metastases
• Interventions: Radiation: BS, SPECT/CT, PET/CT, MRI

• Registration Number: NCT01339780
• Lead Sponsor: Turku University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-20
• Study First Posted: 2011-04-21
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostate Cancer	BS, SPECT/CT, PET/CT, MRI	-
Breast Cancer	BS, SPECT/CT, PET/CT, MRI	-

Primary Outcome Measures

Name	Time	Method
Number of participants with bone metastases	at least 6 months follow up

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Kiinamyllynkatu 4-8, Finland