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.
Conditions
Interventions
Product Name: F-18-Fluoride
Pharmaceutical Form: Solution for injection
CAS Number: 16984-48-8
Current Sponsor code: NaF
Other descriptive name: F-18-Fluoride
Concentration unit: MBq megabecquerel(s)
Sponsors
MUW-Medical University of Vienna,Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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;Primary end point(s): Untreated MM bone lesions (osteolytic lesion), show on the one hand a reduced bone turnover (mineralization status) and on the other hand an increased metabolic activity. It is also well known that MM bone lesions change their tumour behaviour under therapy. The hypothesis of this pilot study is that under response to therapy, MM bone lesions show an increased bone turnover (mineralization) and reduced tumour activity. These changes can be detected with 18F-fluoride-PET/CT and 18F FDG-PET/CT WB and MRI (including DWI). We expect to obtain significant differences in the mineralization of MM bone lesions using 18F-fluoride-PET/CT and tumour activity using 18F FDG-PET/CT of the MM bone lesions before and during therapy.;Timepoint(s) of evaluation of this end point: The study will be performed as a pilot study including 10 patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The study will be performed as a pilot study including 10 patients.;Timepoint(s) of evaluation of this end point: The study will be performed as a pilot study including 10 patients. | — |
Countries
Austria
Contacts
Public ContactMUW
MUW
Outcome results
None listed