Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Prediction of Clinical Response and Outcome in Uterine Cervix Cancer

29 mars 2016 uppdaterad av: Maastricht Radiation Oncology

Predicting Clinical Response and Outcome After Definitive Irradiation With MRI-Guided Adaptive Brachytherapy in Uterine Cervix Cancer

Observational study based on the routine clinical treatment and diagnostic course, to correlate imaging features with outcome objectives. Outcome will evaluated as clinical response to the standard treatment and as recurrence and survival in the follow up. The study hypothesis is that data extracted form FDG-PETCT used in the routine clinical practice can predict outcomes following standard treatment.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

This study will prospectively collect patients undergoing to the standard diagnostic and treatment protocol in Maastro Clinic. Any difference in the normal procedure will be adopted. The aim is to extrapolate form the PET images some features of the metabolic tumor activity to associate with different outcomes and tumor behaviours.

Studietyp

Observationell

Inskrivning (Faktisk)

100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Nederländerna
    • Limburg
      • Maastricht, Limburg, Nederländerna, 6202NA
        • Philippe Lambin

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Histologically proven cervical uterine cancer, undergoing to conventional radiotherapy.

Beskrivning

Inclusion Criteria:

  • Histologically confirmed cervix carcinoma (all subtypes)
  • Tumor Stages FIGO IB - IVA
  • Scheduled for primary curative radiotherapy (either or not combined with chemotherapy or hyperthermia)
  • pre treatment FDG PETCT
  • The patient is willing and capable to comply with study procedures
  • 18 years or older
  • Written informed consent to the treatment

Exclusion Criteria:

  • Recent (< 3 months) myocardial infarction
  • Uncontrolled infectious disease
  • Pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study
  • Previous surgery to the Cervix
  • Previous radiation to the Cervix

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change of SUV-related tumor characteristics predicting recurrence
Tidsram: Changes of parameters will be calculated on the pretreatment scan, than in average 2.5 months after the last radiotherapy session, than at least each 6 month for the first 2 years, eventually shortening the interval if clinically needed
  • Standard Uptake Value Max (SUV- defined as the ratio of tissue radioactivity concentration (e.g. in MBq/kg=kBq/g) at time t, c(t), and the injected activity ( in MBq) at the time of injection (t=0) divided by the body weight in kg),
  • Metabolic Volume (MV) calculated in cc:volume of the evaluable metabolic activity on the PET scan calculated in a specific Region of Interest (ROI) semiautomatically delineated on the primary tumor in the uterine Cervix
Changes of parameters will be calculated on the pretreatment scan, than in average 2.5 months after the last radiotherapy session, than at least each 6 month for the first 2 years, eventually shortening the interval if clinically needed

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change of SUV-related tumor characteristics predicting clinical overall response
Tidsram: Changes of parameters will be calculated on the pretreatment scan, and in average 2.5 months after the last radiotherapy session.
  • Standard Uptake Value Max (SUV- defined as the ratio of tissue radioactivity concentration (e.g. in MBq/kg=kBq/g) at time t, c(t), and the injected activity ( in MBq) at the time of injection (t=0) divided by the body weight in kg),
  • Ratio of Pre/Post treatment SUV MAX,
Changes of parameters will be calculated on the pretreatment scan, and in average 2.5 months after the last radiotherapy session.
Radiomics Features
Tidsram: Radiomics features will be evaluated on the preteratment CT-fdg PET scan in average at least 2 weeks after the end of the accrual.
  • We will apply a high throughput approach to convert medical images to minable data, where it is hypothesized that it will improve tumor characterization and treatment outcome prediction.
  • Extracted imaging features consist firstly of global properties, providing information on the first order histogram of voxel intensity values within the tumor VOI.
  • Local and regional textural features describing patterns and spatial distribution of voxel intensities, are calculated from respectively gray level co-occurrence and gray level run-length matrix representations. Images will be discretized before texture analysis, which allows for a direct comparison of all calculated textural features between patients. Co-occurrence and gray level run-length matrices are determined considering 26-connected voxels (i.e. voxels were considered to be neighbors in all 13 directions in three dimensions) and a distance of 1 between consecutive voxels. Features derived from the co-occurrence and gray
Radiomics features will be evaluated on the preteratment CT-fdg PET scan in average at least 2 weeks after the end of the accrual.
Interobserver variability of Gross Tumor Volume (GTV) contours
Tidsram: GTV's will be delineated 2 weeks after the end of accrual
  • GTV volume in cc contoured by 5 different observers on pretreatment scan: the difference in cc between each contour obtained will be scored
  • GTV Overlapping fraction rate: the overlapping rate of GTV volume between contours
GTV's will be delineated 2 weeks after the end of accrual

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Maastricht Radiation Oncology

Samarbetspartners

Maastricht University Medical Center

Utredare

  • Huvudutredare: philippe Lambin, Maastro Clinic, The Netherlands

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2006

Primärt slutförande (Faktisk)

1 juli 2006

Avslutad studie (Faktisk)

1 januari 2013

Studieregistreringsdatum

Först inskickad

12 november 2012

Först inskickad som uppfyllde QC-kriterierna

7 januari 2013

Första postat (Uppskatta)

9 januari 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

30 mars 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 mars 2016

Senast verifierad

1 mars 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CERVMA01

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Livmoderhalscancer

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Ukraine

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera