HCC Response Assessment by MRI After SBRT

NCT ID: NCT03088423

Last Updated: 2017-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-01
• Study Completion Date: 2015-02-01

Brief Summary

The aim of this work was to describe SBRT different presentations, to study predictive factors for tumor responses following treatment, and to compare tumor response assessments according to the Response Evaluation Criteria

Conditions

Carcinoma, Hepatocellular

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

SBRT delivers high dose selective irradiation with millimeter precision to a small volume. The Cyberknife® is a robotic SBRT dedicated device that can deliver 100 to 200 photobeams to the target

Seven to ten days before the scheduled CT, 2-4 fiducial markers were implanted percutaneously 2 to 5 cm next to the lesion under sonographic guidance following administration of local anesthesia, thus allowing real-time tracking during treatment. The total dose delivered was 45 Gy on the 80% isodose, in three fractions over 10 days. Gross tumor volume (GTV) was defined as the tumor mass that could be discerned by diagnostic imaging. An isotropic margin of 5 mm was added to account for the microscopic extension (clinical target volume, CTV) and another 3 mm margin was added to compensate for uncertainties regarding the position (previsional target volume, PTV)

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Inclusion Criteria: the standard criteria for treating HCC patients with SBRT : an Eastern Cooperative Oncology Group (ECOG) score of 2, inoperable tumors (e.g. the patient being unfit for surgery, or tumor-related contraindications), and a maximum tumor diameter of 6 cm.

Exclusion Criteria

The HCC diagnosis could be histological or based on the radiological criteria of the American Association for the Study of Liver Diseases (AASLD) * Exclusion Criteria:no follow-up by MR imaging

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2013_ICL_0001

Identifier Type: -

Identifier Source: org_study_id