Clinical trial NCT02187731: Functional Imaging in Multiple Myeloma -PET/CT and Diffusion Weighted Imaging in Multiple Myeloma
Official title: FULIMA - A Prospective Study of Dual Time PET/CT and Diffusion Weighted MRI in Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Functional Imaging
PET/CT
Diffusion Weighted MRI
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 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.


Eligibility 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)

Primary outcomes:
measure: Multiple myeloma identified as bone disease, myeloma or plasmacytoma
timeFrame: "baseline"
Secondary outcomes:
measure: Disease heterogeneity
timeFrame: Within 2 weeks after imaging procedures
measure: Early signs of bone remodeling
timeFrame: "baseline", after induction treatment and after end of treatment
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Brian Oestergaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zadeh MZ, Seraj SM, Ostergaard B, Mimms S, Raynor WY, Aly M, Borja AJ, Arani LS, Gerke O, Werner TJ, Zhuang H, Revheim ME, Abildgaard N, Hoilund-Carlsen PF, Alavi A. Prognostic significance of 18F-sodium fluoride in newly diagnosed multiple myeloma patients. Am J Nucl Med Mol Imaging. 2020 Aug 25;10(4):151-160. eCollection 2020.