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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01339780
Other study ID # 113/180/2010
Secondary ID
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


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
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