NCT00926536

Brief Summary

Patients will be enrolled based on presence of HCC and eligibility for TACE. They will be randomized to one of two arms for imaging navigation to the optimal catheter location for chemotherapy injection to treat the first (possibly sole) tumor target. The two arms will be: TACE using C-arm CT supplemented by DSA or DSA only (only DSA images will be used for navigation and tumor vessel tracking). Navigation to subsequent treatment targets in all patients will be done with fluoroscopy, CACT, and DSA, as is standard of care at Stanford University Medical Center, and is not part of the study. Vascular complexity, which affects navigation difficulty and thus the need for imaging, will be assessed separately for use in data analysis by two radiologists on a four-point scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

April 4, 2016

Completed
Last Updated

April 4, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

June 22, 2009

Results QC Date

December 4, 2014

Last Update Submit

March 10, 2016

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (2)

  • Dose Area Product (DAP)

    Dose area product (DAP) is a measure of the entire amount of energy (radiation dose) delivered to the patient by the beam (indicator of stochastic dose)

    Duration of a TACE procedure, an average of 2 hours

  • Cumulative Dose (CD), a Measure of Radiation Dose

    CD - a measurement of total radiation to the skin (measure of a deterministic dose)

    Duration of a TACE procedure, an average of 2 hours

Study Arms (2)

C-arm CT + DSA as needed'

EXPERIMENTAL

In the group of subjects randomized in this group, the image guidance component of the procedure will be conducted by the acquisition of 3D CT-like images during a trans-hepatic arterial injection of iodinated contrast agent for road mapping the tumor feeding vessels and supplemented by DSA as needed by the operating physician as imaging guidance for planning tumor(s) treatment approach.

Device: C-arm CT + DSA as needed

DSA only

ACTIVE COMPARATOR

In the group of subjects randomized in this group, present standard of care, i.e DSA imaging only will be used by the operating physician to map out the tumor vessels and used for treatment approach. Additional 3D CT-like images will be obtained, but only used if the operator cannot perform adequate planning using DSA alone.

Device: DSA only

Interventions

C-arm CT + DSA as neededDEVICE

C-arm CT images obtained and supplemented with DSA if needed

Also known as: x-ray image intensifier, C-arm CT
C-arm CT + DSA as needed'
DSA onlyDEVICE

DSA imaging only

Also known as: Standard of care
DSA only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be affected by HCC
  • Patients must be 18 years old or older
  • Patients must have received an abdominal CT, PET/CT scan or MRI, completed prior to the TACE procedure.
  • Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

  • Subjects under the age of 18
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This is an imaging study looking at two different modalities of imaging. There is no long term follow up or A/Es associated with this type of a study

Results Point of Contact

Title
Dr Nishita Kothary
Organization
Stanford University
kothary@stanford.edu
6504986020

Study Officials

  • Dr. Rebecca Fahrig

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Nishita N. Kothary

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 23, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 4, 2016

Results First Posted

April 4, 2016

Record last verified: 2016-03

Locations

US(1)