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PET/CT in Diagnosing Patients With Liver Cancer Undergoing Surgical Resection

29 augusti 2018 uppdaterad av: Sandi Kwee, Queen's Medical Center

Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer

This clinical trial studies positron emission tomography (PET)/computed tomography (CT) in diagnosing patients with liver cancer undergoing surgical resection. Diagnostic procedures, such as fluorine-18 fluoromethylcholine PET/CT, may help find and diagnose liver cancer.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVES:

I. Determine the most optimal fluorine-18 (18F) fluoromethylcholine (FCH) PET/CT parameters for detecting primary hepatocellular carcinoma (HCC) by conducting a clinical radiologic-pathologic correlation study to estimate and compare the receiver operating characteristics of kinetic and static PET measures of tumor FCH metabolism in patients that test positive during screening or conventional imaging.

II. Identify cancer signaling pathways associated with choline metabolism in HCC by profiling the global gene expression patterns in fresh-frozen liver tissue samples that are correlated with the features derived from FCH PET/CT images.

III. Characterize the association between features derived from FCH PET/CT images of the liver and clinical liver disease severity and comparatively evaluate the ability of corresponding gene expression signatures to predictively model HCC disease outcome.

OUTLINE:

Patients undergo 18F-fluoromethylcholine PET/CT within 14 days of surgical resection.

After completion of study treatment, patients are followed up periodically.

Studietyp

Interventionell

Inskrivning (Faktisk)

64

Fas

  • Fas 2

Kontakter och platser

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

Studieorter

  • Förenta staterna
    • Hawaii
      • Honolulu, Hawaii, Förenta staterna, 96813
        • University of Hawaii Cancer Center

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

19 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Liver tumor diagnosed histologically as HCC or suspected of being HCC in association with serum alpha-fetoprotein level > 200 or tumor mass with characteristics of malignancy on diagnostic imaging
  • Under the care of a surgical attending
  • Deemed a surgical candidate and has agreed to surgery to remove a portion of the liver containing tumor
  • Child-Pugh A/B

Exclusion Criteria:

  • Weight > 350 lbs
  • Pregnant or lactating female, a serum pregnancy test will be performed within 2 weeks or less before the date of the FCH PET/CT scan in all women capable of becoming pregnant
  • Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure
  • Concurrent treatment with chemotherapy, molecule-selective, biological, or radiotherapeutic agent

Studieplan

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

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 18F-fluoromethylcholine PET/CT
Patients undergo 18F-fluoromethylcholine positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection of liver tumor.
Diagnostiskt test: Computed Tomography
Undergo FCH PET/CT
Andra namn:
  • CT
  • Datoriserad axialtomografi
  • tomografi
  • datoriserad tomografi
  • Datortomografi
Läkemedel: 18F-fluoromethylcholine
Undergo FCH PET/CT
Andra namn:
  • FCH
  • fluorine-18 fluoromethylcholine
  • 18F-fluorokolin
  • 18F-choline
Diagnostiskt test: Positron Emission Tomography
Undergo FCH PET/CT
Andra namn:
  • Medicinsk avbildning, Positron Emission Tomografi
  • SÄLLSKAPSDJUR
  • Djur Scan
  • Positron Emission Tomography Scan
  • Positronemissionstomografi
  • protonmagnetisk resonansspektroskopisk avbildning

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Area Under the Receiver Operating Characteristic Curve.
Tidsram: Up to study completion at an average of 2.5 years
Area under the receiver operating characteristic curve for detecting resectable hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax).
Up to study completion at an average of 2.5 years
Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Sensitivity/Specificity
Tidsram: Up to study completion at an average of 2.5 years
Sensitivity and specificity estimated at a predefined point (ie. Youden's maxima) on the receiver operating characteristic curve for detecting hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax) in patients who underwent subsequent tumor resection.
Up to study completion at an average of 2.5 years
Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples.
Tidsram: Up to study completion at an average of 2.5 years
Statistically significant enrichment by sets of genes corresponding to previously-defined molecular pathway signatures was assessed by gene set enrichment analysis (a publicly available algorithm) of whole-genome expression array data obtained from tumors previously characterized by FCH PET/CT. Statistical significance was based on a false discovery rate < 0.05. Tumors demonstrating high choline metabolism (defined by a tumor-liver ratio > 1.0 measured on PET) were assessed for enrichment by publicly-available gene sets. This particular analysis involved the entire Molecular Hallmarks gene signature collection (v6.0) as obtained from the Broad Institute Molecular Signature Database (MSigDB).
Up to study completion at an average of 2.5 years
Clinical Liver Disease Severity Based on Liver Fibrosis (Metavir) Stage
Tidsram: Up to 1 year
Odds ratios and 95% confidence intervals for histologic liver fibrosis (Metavir) stage >= F1, >= F2, >= F3, and F4 at liver standardized uptake value (SUV) thresholds of 8.3, 8.0, 7.4, and 6.4, respectively. Reference: PMID 29315063.
Up to 1 year
Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
Tidsram: Up to study completion at an average of 2.5 years
HCC tumors were sub-classified using gene expression arrays into 3 distinct prognostically-relevant molecular sub-classes (S1,S2, S3, where S3 is associated with the most favorable clinical prognosis) based on Hoshida et. al (PMID 19723656). The number of tumors comprising two distinct PET/CT imaging phenotypes (high FCH uptake vs. low FCH uptake) was compared between the different sub-classes.
Up to study completion at an average of 2.5 years

Samarbetspartners och utredare

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

Sponsor

Queen's Medical Center

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Sandi Kwee, MD, Queen's Medical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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 (Faktisk)

15 augusti 2011

Primärt slutförande (Faktisk)

31 maj 2017

Avslutad studie (Faktisk)

31 maj 2018

Studieregistreringsdatum

Först inskickad

12 juli 2011

Först inskickad som uppfyllde QC-kriterierna

13 juli 2011

Första postat (Uppskatta)

15 juli 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 september 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 augusti 2018

Senast verifierad

1 augusti 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RA-2011-025 (Annan identifierare: Queen's Medical Center)
  • NCI-2012-02095 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • CHS-19373 (Annan identifierare: University of Hawaii)
  • R01CA161209 (U.S.S. NIH-anslag/kontrakt)

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 .

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