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Trial Title:
Functional Imaging in Multiple Myeloma -PET/CT and Diffusion Weighted Imaging in Multiple Myeloma
NCT ID:
NCT02187731
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Body Weight
Conditions: Keywords:
Multiple Myeloma
Functional Imaging
PET/CT
Diffusion Weighted MRI
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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 with focus on PET/CT and MRI.
By combining early (1 hour) and late (3 hours) 18F-2-fluoro-2-deoxy-D-
fluorodeoxyglucose(18F-FDG)-PET/CT scans the investigators expect to see increased uptake
of radioactive tracer and thus an improved ability to identify malignant tissue. A second
tracer 18F-natrium-fluoride is used to explore early signs of bone remodeling. By using
new software (ROVER) for interpreting PET data the investigators expect to obtain a
quantitative measurement of total disease burden with less risk of misinterpretation of
data.
Diffusion weighted MRI (DWI) is a new MRI technique which, like PET/CT, makes it possible
quantitatively to calculate the overall disease activity and to give an early evaluation
of response to chemotherapy. The study examines DWI for development and standardization.
To validate imaging findings and to explore the pathogenetic heterogeneity of multiple
myeloma, the investigators perform CT guided biopsies from PET/ DWI positive sites.
Pathoanatomical and immunohistochemical findings and gene expression data from positive
sites are compared to random bone marrow. The question is whether disease heterogeneity
may explain the lack of FDG uptake in bone marrow in some patients? To the extent that
the FULIMA study produces useful data, the defined and standardized imaging techniques
will form the basis of a larger prospective study at national level in Denmark.
Criteria for eligibility:
Study pop:
Prospective study with 60 patients referred to Haematological Department under the
suspicion of having treatment demanding multiple myeloma. Patients will be included from
two centres of Haematology.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Male or female subjects > 50 years at time of signing informed consent.
2. Subject under suspicion of having treatment demanding multiple myeloma in
concordance with Danish cancer package criteria
3. Signed informed consent before performance of any study related procedures.
4. Subject is willing and able to comply with the protocol as judged by the
investigator.
Exclusion Criteria:
1. Formerly treated multiple myeloma.
2. Known inflammatory disease, recent biological therapies or chemotherapy for
non-malignant disease (less than 3 months prior to screening), clinically relevant
active infection.
3. Concurrent or recent radiotherapy or surgery less than two weeks prior to screening
4. Glucocorticoid treatment exceeding 10 mg Prednisolone daily, less than two weeks
prior to screening.
5. 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.
6. Female subject is pregnant or breast feeding.
7. Serious co-morbidity, and other medical or psychiatric illness likely to interfere
with participation in this clinical study.
8. Uncontrolled diabetes at the discretion of the investigator.
9. 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.
10. POEMS syndrome (plasma cell dyscrasia with poly-neuropathy, organomegaly,
endocrinopathy, monoclonal protein (M-protein) and skin changes).
11. Exclusion according to MRI procedure (metal implants, claustrophobia, pace-maker).
12. Exclusion according to biopsy study (thrombocytes < 50x /L, activated partial
thromboplastin time(APTT) > 40 sec, and international normalized ratio(INR) > 1.5)
Gender:
All
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Odense University Hospital
Address:
City:
Odense C
Zip:
5000
Country:
Denmark
Start date:
June 2013
Completion date:
December 2020
Lead sponsor:
Agency:
Odense University Hospital
Agency class:
Other
Source:
Odense University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02187731