Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 13/24748 | Registry Identifier | Danish Dataprotection Agency |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Multiple myeloma identified as bone disease, myeloma or plasmacytoma | A 1st complete set of imaging procedures is completed at time of diagnosis "baseline" (week 1-2) for all patients included in the study. The primary hypothesis that 3-hour FDG-PET / CT finds more malignant lesions than the current gold standard procedure, whole body x-ray(WBXR), together with CT and MRI. Concordance analysis will be done by summarizing comparisons of 3-hours FDG-PET/CT versus the remaining modalities. We measure a 95% Wilson-Score Confidence Interval (CI) to demonstrate that 3hours FDG-PET / CT find more malignant lesions than gold standard. This will be concluded at a significance level of 5% if the lower boundary of the 95% CI is larger than 30%. | "baseline" |
| Measure | Description | Time Frame |
|---|---|---|
| Disease heterogeneity | CT guided or Ultra Sound guided biopsies from PET/ DWI positive sites. Pathoanatomical and immunohistochemical findings and gene expression data from positive sites are compared to random bone marrow. | Within 2 weeks after imaging procedures |
| Early signs of bone remodeling |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian Oestergaard, MD | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense C | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32929393 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
18F-natrium-fluoride-PET/CT is performed at time of diagnosis (baseline) during week 1-2, after induction treatment and after end of treatment. We test if increased 18F-natrium-fluoride uptake is seen in bone sites where, according to CT and DWI, no abnormal bone remodeling is taking place and we observe the association between FDG-PET and fluoride-PET and markers of bone metabolism. We use descriptive statistics for number of bone sites with increased fluoride uptake, 95% Confidence interval |
| "baseline", after induction treatment and after end of treatment |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |