Characterization of myeloma bone lesions - before and during anti-cancer therapy - using 18F-FDG-, 18F-fluoride PET/CT and MRI-a pilot study
- Conditions
- The primary aim of this study is the characterization of WB MRI detected untreated MM bone lesions in consideration of the mineralization status and tumor activity using 18F-fluorid-PET/CT and 18F FDG-PET/CT. The second aim of this pilot study is the re-evaluation (after three month) of the detected bone lesion during therapy with the same diagnostic modalities to detect potential changes in the mineralization and tumor activity in MM bone lesions.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2011-002692-42-AT
- Lead Sponsor
- MUW-Medical University of Vienna,Medizinische Universität Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Ten patients (age: 18-70 years) with diagnosed multiple myeloma stage III by the Durie/Salmon PLUS staging System will be included in the present pilot study. No patients will have received anti-cancer therapy before the start of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Pregnancy (excluded with a pregnancy test), breast-feeding women, patients that are not able to lie motionless for one hour.
Patients suffering on cardiac insufficiency and severe hypertonia.
Patients with acute or chronic renal failure.
Palliative treatment, recurrent disease, neoadjuvant chemotherapy, other pre-existing malignancies, age > 70 years.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method