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

Primary Purpose

Bone Metastases

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
BS, SPECT/CT, PET/CT, MRI
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bone Metastases

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Breast Cancer

Prostate Cancer

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with bone metastases

Secondary Outcome Measures

Full Information

First Posted
April 20, 2011
Last Updated
February 26, 2014
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01339780
Brief Title
Imaging of Prostate and Breast Cancer Bone Metastases Using Magnetic Resonance Imaging and Nuclear Medicine Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breast Cancer
Arm Type
Experimental
Arm Title
Prostate Cancer
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
BS, SPECT/CT, PET/CT, MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with bone metastases
Time Frame
at least 6 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Turku University Hospital
City
Turku
State/Province
Kiinamyllynkatu 4-8
ZIP/Postal Code
20521
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

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

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