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OpenTrials
Completed

NCT Number: NCT02519075

11C-Choline PET/CT and DWI MRI for Response Assessment of HCC Candidate to TARE

Prospective exploratory study specifically investigating the diagnostic and predictive role of 11C-Choline PET/CT and DWI MRI for response assessment in patients affected by HCC and candidate to TARE. A minimum number of 20 patients will be considered for the analysis.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

About this study

For the study, all patients with a histological diagnosis of HCC and eligible for TARE, i.e. with liver predominant disease who are not eligible for curative surgery, after multidisciplinary discussion will be included. In all cases, patients will undergo 11C-Choline PET/CT and DWI MRI before starting radioembolization and will be subsequently restaged 3 months after treatment completion. A minimum number of 20 patients will be considered for the analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with a histological diagnosis of HCC and eligible for TARE, i.e. with liver predominant disease who are not eligible for curative surgery, after multidisciplinary discussion will be included;
  • obtained informed consent

Exclusion criteria

  • patients age <18 years
  • pregnancy or breast-feeding;
  • patients affected by other malignancies within the last 3 years;
  • disseminated extrahepatic disease;
  • severely abnormal excretory liver function tests or ascites suggestive of liver failure;
  • hepatopulmonary shunt >20%;
  • vascular variants and abnormalities as demonstrated on pre-treatment angiography, which cannot be corrected by embolisation and which lead to reflux of hepatic arterial blood to the stomach, pancreas or bowel.

Treatment and study plan

No intervention

Other

Observational study

Primary outcomes

  1. Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing TARE for HCC

    Time frame: Change from Baseline in SUVmax up to 3 months after TARE

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Diagnostic and Prognostic Role of 11C-Choline PET/CT and DWI MRI for Response Assessment in Patients Affected by Hepatocellular Carcinoma (HCC) and Candidate to TARE

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2015
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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