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Noninvasive Surrogate Marker for Advanced Hepatocellular Carcinoma Response to Concurrent Chemoradiotherapy: MR Perfusion, Contrast Enhanced Ultrasound and Biomarkers


N/A
20 Years
N/A
Open (Enrolling)
Both
Advanced Adult Hepatocellular Carcinoma

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Trial Information

Noninvasive Surrogate Marker for Advanced Hepatocellular Carcinoma Response to Concurrent Chemoradiotherapy: MR Perfusion, Contrast Enhanced Ultrasound and Biomarkers


Inclusion Criteria:



- Patients who have advanced hepatocellular carcinoma and plan to undertake concurrent
chemoradiotherapy.

- Patients willing to undergo the study procedure

- Patients who are fully informed about the study and have signed the informed consent
form

Exclusion Criteria:

- Patients (men or women) under 20 years of age

- Patients who have been received any other treatment including TACE, operation, TACI,
systemic chemotherapy, intraarterial chemotherapy, antiangiogenic therapy

- Patients who have hypersensitivity to MR or US contrast agents

- Women who are pregnant, lactating or who are of childbearing potential and have not
had a negative pregnancy test at baseline visit

- Patients not eligible to contrast media injection according to product labeling

- Patients with a contraindication for MRI or CT

- Patients with impaired renal function (e.g. acute renal failure) or patients on
dialysis

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

characteristic of Perfusion MR

Outcome Description:

Ktrans (volume transfer constant between the EES and the blood plasma), Kep (rate constant between the EES and the blood plasma), Ve (Ktrnas/Kep: EES fractional volume), tumor volume

Outcome Time Frame:

1 month

Safety Issue:

No

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

4-2010-0566

NCT ID:

NCT01336452

Start Date:

April 2011

Completion Date:

December 2013

Related Keywords:

  • Advanced Adult Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

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