Status:
UNKNOWN
Functional Imaging in Multiple Myeloma -PET/CT and Diffusion Weighted Imaging in Multiple Myeloma
Lead Sponsor:
Odense University Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
50+ years
Brief Summary
The FULIMA study is a two-center study at Odense University Hospital and Vejle Hospital, Denmark. The primary objective is to identify the optimal imaging technique for studies in multiple myeloma wit...
Eligibility Criteria
Inclusion
- Male or female subjects \> 50 years at time of signing informed consent.
- Subject under suspicion of having treatment demanding multiple myeloma in concordance with Danish cancer package criteria
- Signed informed consent before performance of any study related procedures.
- Subject is willing and able to comply with the protocol as judged by the investigator.
Exclusion
- Formerly treated multiple myeloma.
- Known inflammatory disease, recent biological therapies or chemotherapy for non-malignant disease (less than 3 months prior to screening), clinically relevant active infection.
- Concurrent or recent radiotherapy or surgery less than two weeks prior to screening
- Glucocorticoid treatment exceeding 10 mg Prednisolone daily, less than two weeks prior to screening.
- Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk if s/he were to participate in the study, e.g. high levels of liver-enzymes and creatinine.
- Female subject is pregnant or breast feeding.
- Serious co-morbidity, and other medical or psychiatric illness likely to interfere with participation in this clinical study.
- Uncontrolled diabetes at the discretion of the investigator.
- Known or prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer or in situ prostate cancer for which the subject has been disease free for at least three years.
- POEMS syndrome (plasma cell dyscrasia with poly-neuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes).
- Exclusion according to MRI procedure (metal implants, claustrophobia, pace-maker).
- Exclusion according to biopsy study (thrombocytes \< 50x /L, activated partial thromboplastin time(APTT) \> 40 sec, and international normalized ratio(INR) \> 1.5)
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02187731
Start Date
June 1 2013
End Date
December 1 2020
Last Update
August 29 2018
Active Locations (1)
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1
Odense University Hospital
Odense C, Denmark, 5000