NCT02550613

Brief Summary

The purpose of this study is to explore the ability of integrated MRI/PET to detect and evaluate treatment outcome in HCC patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

3.9 years

First QC Date

September 14, 2015

Last Update Submit

May 14, 2017

Conditions

Hepatocellular Carcinoma

Keywords

MR/PET, hepatocellular carcinoma, HCC

Outcome Measures

Primary Outcomes (1)

  • The recurrence rate at 3 months after treatment

    3 months

Secondary Outcomes (1)

  • The overall survival after treatment

    1 year

Interventions

The imaging biomarkers determined by MR-PETDEVICE

The purpose of this study is to explore the ability of integrated MRI/PET to detect and evaluate treatment outcome in HCC patients. This study using 18F-FDG PET and functional MRI (DCE-MRI, Diffusion-weighted MRI, MR spectroscopy).

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will enroll 100 HCC patients who are admitted for curative or non-curative treatments, including operation, radiofrequency ablation, TACE, target therapy, chemotherapy, or radiotherapy.

You may qualify if:

  • Prior Informed Consent Form
  • At least one measurable tumor, according to RECIST version 1.1.
  • Age \> 20 years.
  • ECOG performance status 0 or 1.
  • Life expectancy \> 3 months.
  • Confirmed Diagnosis of HCC
  • Adequate renal function (Serum creatinine ≦ 1.5 x upper limit of normal).

You may not qualify if:

  • Age \<20 years old
  • Pregnancy
  • Contraindication for MRI: claustrophobia or MR non-compatible devices
  • Contraindication for MR contrast medium: severe adverse reaction or impaired renal function (Cre \> 2.0)
  • History of other malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Bang-Bin Chen, MD

    Department of Medical Imaging, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting-Fang Shih, MD

CONTACT

+886-2-23123456ttfshih@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 15, 2015

Study Start

May 1, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

TW(1)