18F-FDG PET in HCC Patients Candidate to Treatment With Sorafenib

NCT02977754 | Completed DMC

• 1 other identifier: 1458
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The principal objective of this study is to explore the role of 18F-FDG PET in identifying sorafenib-induced metabolic shift in HCC, thus in predicting treatment response and disease outcome in advanced HCC patients candidate to systemic treatment with sorafenib.

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

• Early change of metabolic characteristics (i.e. SUVmax, SUVmean, MTV, TLG) of HCC lesions under Sorafenib

  Baseline parameters

  Compare 18F-FDG uptake in HCC lesions at baseline and at 24 hours after the first administration of sorafenib.

Secondary Outcomes (3)

• Change of metabolic characteristics (i.e. SUVmax, SUVmean, MTV, TLG) of HCC lesions under Sorafenib

  Compare 18F-FDG uptake in HCC lesions at baseline and 1 week after the first administration of sorafenib.

• Predictive role of metabolic characteristics of HCC (i.e. SUVmax, SUVmean, MTV, TLG) lesions under Sorafenib

  Correlate the patterns of 18F-FDG uptake in HCC lesions with objective tumor response assessed 8 weeks after the first administration of sorafenib according to mRECIST criteria

• Prognostic role of metabolic characteristics (i.e. SUVmax, SUVmean, MTV, TLG) of HCC lesions under Sorafenib

  Correlate the patterns of 18F-FDG uptake in HCC lesions with progression-free survival (PFS) and overall survival (OS) assessed during a minimun of 12 months of follow up

Other Outcomes (1)

• Correlate tumor markers with metabolic characteristics (i.e. SUVmax, SUVmean, MTV, TLG) of HCC lesions under Sorafenib

  Correlate the patterns of 18F-FDG uptake in HCC lesions with alpha-fetoprotein (AFP) measured at baseline and after 8 weeks of treatment

Interventions

This is an observational study OTHER

Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a single-center, single-arm study, lasting 36 months including an estimated period of 24 months for the enrolment and max 12 months of follow-up. All patients affected by HCC and referred to our Institution for systemic treatment with sorafenib will be evaluated for enrolment. A minimum number of 10 patients will be considered for the analysis.

You may qualify if:

• patients with an histological diagnosis of HCC and scheduled to undergo systemic treatment with sorafenib;
• obtained informed consent

You may not qualify if:

• patients age \<18 years
• pregnancy or breast-feeding;
• patients affected by other malignancies within the last 3 years, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Related Publications (1)

• Castello A, Rimassa L, Personeni N, Pressiani T, Smiroldo V, Lopci E. Metabolic Switch in Hepatocellular Carcinoma Patients Treated with Sorafenib: a Proof-of-Concept Trial. Mol Imaging Biol. 2020 Oct;22(5):1446-1454. doi: 10.1007/s11307-020-01489-6.

  PMID: 32206991 BACKGROUND

Study Officials

• Egesta Lopci

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 30, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)