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

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ClinicalTrials.gov Identifier: NCT02519075
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Brief Summary:
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.

Condition or disease Intervention/treatment
Hepatocarcinoma Other: No intervention

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Other
Time Perspective: Prospective
Official 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
Actual Study Start Date : April 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Intervention Details:
  • Other: No intervention
    Observational study


Primary Outcome Measures :
  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 ]

Biospecimen Retention:   None Retained
Biopsy specimen


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients affected by HCC and referred to our Institution for TARE will be enrolled.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519075


Locations
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Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Egesta Lopci, MD Humanitas Clinical and Research Hospital
Publications:
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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02519075    
Other Study ID Numbers: 1386
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Keywords provided by Istituto Clinico Humanitas:
Hepatocarcinoma
TARE
response assessment
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases