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Status unknownNCT01336452Updated Jun 4, 2013

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

An interventional study of DCE MRI in Advanced Adult Hepatocellular Carcinoma, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-06-04.

Sponsored by Yonsei University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
20 Years and older
Sex
All
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Study summary

Hepatocellular carcinoma is the sixth most common malignancy and the third most common cause of cancer-related death worldwide. The incidence of HCC is rising in Europe and the United States and is expected to continue to increase during the next 2 to 3 decades. The expected survival rate is still decimal, especially in patients with advanced HCC. However, in recent years, several treatment methods for patients with advanced HCC, including antiangiogenic chemotherapy, radiotherapy, concurrent chemoradiotherapy, and DC bead transarterial chemoembolization, have been developed. Among these new treatment methods, concurrent chemoradiotherapy has also proved to increase patient's survival rate. It is important to predict treatment response before treatment or immediately after treatment because there are several other treatment options as mentioned above. Recently, there have been several reports that MR perfusion parameters such as Ktrans can predict treatment response in cervical cancer and colorectal cancer. Therefore the purpose of the investigators study is to evaluate the feasibility of predicting treatment response by MR perfusion, contrast enhanced ultrasound parameters and biomarkers (IL-6, IL-12 and VEGF) in patients with advanced hepatocellular carcinoma who undertake concurrent chemoradiotherapy.

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Conditions studied

  • Advanced Adult Hepatocellular Carcinoma
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 30 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    CCRTx

    consecutive patients who plan to undertake CCRTx due to advanced hepatocellular carcinoma

    Radiation: DCE MRI

Interventions

  • RadiationDCE MRI

    DCE (dynamic contrast enhanced) MRI will be obtained just before CCRTx and immediately after finishing CCRTx with 0.1mmol/kg of MR contrast media; CEUS will be obtained just before CCRTx, immediately after finishing CCRTx, and 1 month after CCRTx with 2.4 mL of SonoVue. Blood sampling for biomarker analysis will be performed just before CCRTx, immediately after finishing CCRTx, and 1 month after CCRTx (20mL)

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What researchers measure

Primary outcomes

  1. characteristic of Perfusion MR

    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

    Time frame: 1 month

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Study locations

1 of 1 sites recruiting
  • Severance Hospital
    Seoul, 120-752, Korea, Republic of
    • Yong-Eun Chung, MD, Ph.D · Contact · radpms@yuhs.ac · 82-2-2228-7400
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01336452
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Apr 15, 2011
Start date
Apr 2011
Primary completion
Dec 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Jun 4, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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