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

NCT01339780 | Completed

• 1 other identifier: 113/180/2010
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (1)

• Number of participants with bone metastases

  at least 6 months follow up

Study Arms (2)

Breast Cancer

EXPERIMENTAL

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

Prostate Cancer

EXPERIMENTAL

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

Interventions

BS, SPECT/CT, PET/CT, MRI RADIATION

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.

Breast Cancer; Prostate Cancer

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital

Turku, Kiinamyllynkatu 4-8, 20521, Finland

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 21, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

FI (1)