- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02187731
Functional Imaging in Multiple Myeloma -PET/CT and Diffusion Weighted Imaging in Multiple Myeloma (FULIMA)
FULIMA - A Prospective Study of Dual Time PET/CT and Diffusion Weighted MRI in Multiple Myeloma
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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Odense C, Dánsko, 5000
- Odense University Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- 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 Criteria:
- 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)
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Multiple myeloma identified as bone disease, myeloma or plasmacytoma
Časové okno: "baseline"
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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%.
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"baseline"
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Disease heterogeneity
Časové okno: Within 2 weeks after imaging procedures
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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.
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Within 2 weeks after imaging procedures
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Early signs of bone remodeling
Časové okno: "baseline", after induction treatment and after end of treatment
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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
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"baseline", after induction treatment and after end of treatment
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Brian Oestergaard, MD, Odense University Hospital
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Kardiovaskulární choroby
- Cévní onemocnění
- Onemocnění imunitního systému
- Novotvary podle histologického typu
- Novotvary
- Lymfoproliferativní poruchy
- Imunoproliferativní poruchy
- Hematologická onemocnění
- Hemoragické poruchy
- Hemostatické poruchy
- Paraproteinémie
- Poruchy krevních bílkovin
- Mnohočetný myelom
- Novotvary, plazmatické buňky
- Tělesná hmotnost
Další identifikační čísla studie
- S-20120209
- 13/24748 (Identifikátor registru: Danish Dataprotection Agency)
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