Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

28. august 2018 oppdatert av: Brian Oestergaard, Odense University Hospital

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.

Studieoversikt

Status

Ukjent

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

70

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Danmark
      • Odense C, Danmark, 5000
        • Odense University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Multiple myeloma identified as bone disease, myeloma or plasmacytoma
Tidsramme: "baseline"
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"

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Disease heterogeneity
Tidsramme: Within 2 weeks after imaging procedures
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
Tidsramme: "baseline", after induction treatment and after end of treatment
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Odense University Hospital

Etterforskere

  • Hovedetterforsker: Brian Oestergaard, MD, Odense University Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2013

Primær fullføring (Forventet)

1. desember 2019

Studiet fullført (Forventet)

1. desember 2020

Datoer for studieregistrering

Først innsendt

23. april 2014

Først innsendt som oppfylte QC-kriteriene

10. juli 2014

Først lagt ut (Anslag)

11. juli 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • S-20120209
  • 13/24748 (Registeridentifikator: Danish Dataprotection Agency)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere