11C-Choline PET/CT and DWI MRI for Response Assessment of HCC Candidate to TARE
Study Details
Study Description
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 | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing TARE for HCC [Change from Baseline in SUVmax up to 3 months after TARE]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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obtained informed consent
Exclusion Criteria:
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patients age <18 years
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pregnancy or breast-feeding;
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patients affected by other malignancies within the last 3 years;
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disseminated extrahepatic disease;
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severely abnormal excretory liver function tests or ascites suggestive of liver failure;
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hepatopulmonary shunt >20%;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituto Clinico Humanitas | Rozzano | Milano | Italy | 20089 |
Sponsors and Collaborators
- Istituto Clinico Humanitas
Investigators
- Principal Investigator: Egesta Lopci, MD, Humanitas Clinical and Research Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
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