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

Hepatocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519075
• Other study ID #: 1386
• Status: Completed
• Start date: April 2015
• Est. completion date: December 2018

Study information

• Verified date: September 2020
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocarcinoma

Intervention

Other:
• No intervention
Observational study

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Castello, A., Lopci, E. Imaging HCC treated with radioembolization: review of the literature and clinical examples of choline PET utility. Clin Transl Imaging (2020). https://doi.org/10.1007/s40336-020-00384-y

Lanza E, Donadon M, Felisaz P, Mimmo A, Chiti A, Torzilli G, Balzarini L, Lopci E. Refining the management of patients with hepatocellular carcinoma integrating 11C-choline PET/CT scan into the multidisciplinary team discussion. Nucl Med Commun. 2017 Oct;38(10):826-836. doi: 10.1097/MNM.0000000000000719. — View Citation

Lopci E, Torzilli G, Poretti D, de Neto LJ, Donadon M, Rimassa L, Lanza E, Sabongi JG, Ceriani R, Personeni N, Palmisano A, Pedicini V, Comito T, Scorsetti M, Chiti A. Diagnostic accuracy of ¹¹C-choline PET/CT in comparison with CT and/or MRI in patients with hepatocellular carcinoma. Eur J Nucl Med Mol Imaging. 2015 Aug;42(9):1399-407. doi: 10.1007/s00259-015-3079-5. Epub 2015 May 12. — View Citation

Talbot JN, Gutman F, Fartoux L, Grange JD, Ganne N, Kerrou K, Grahek D, Montravers F, Poupon R, Rosmorduc O. PET/CT in patients with hepatocellular carcinoma using [(18)F]fluorocholine: preliminary comparison with [(18)F]FDG PET/CT. Eur J Nucl Med Mol Imaging. 2006 Nov;33(11):1285-9. Epub 2006 Jun 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing TARE for HCC		Change from Baseline in SUVmax up to 3 months after TARE