Functional Imaging in Multiple Myeloma -PET/CT and Diffusion Weighted Imaging in Multiple Myeloma

NCT02187731 | Unknown DMC

• 2 other identifiers: S-2012020913/24748
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Functional Imaging; PET/CT; Diffusion Weighted MRI

Outcome Measures

Primary Outcomes (1)

• 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"

Secondary Outcomes (2)

• Disease heterogeneity

  Within 2 weeks after imaging procedures

• Early signs of bone remodeling

  "baseline", after induction treatment and after end of treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32929393 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Brian Oestergaard, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: July 11, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

DK (1)