NCT02288910

Brief Summary

This project investigates the feasibility of assessing the relative blood volume of carcinomas in patients with Hepatocellular Carcinoma (HCC) and liver metastases from pancreatic or colorectal cancer compared to normal liver from DynaCT acquisitions on an interventional platform.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

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

November 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

4.7 years

First QC Date

November 5, 2014

Last Update Submit

October 5, 2020

Conditions

Hepatocellular CarcinomaMetastatic Carcinoma to the Liver

Keywords

Liver PerfusionDynaCT PerfusionRadioembolizationChemoembolization

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of PBV maps

    The accuracy of the DynaCT BV protocol as an indicator of healthy vs. liver tumor compared to the body CT perfusion study will evaluated using a receiver operating characteristic curve.

    1 year

Secondary Outcomes (2)

  • Relationship between blood volume values and patient treatment response

    1,4,7,13,19 months

  • PBV blood volume value accuracy

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with non-diffuse hepatocellular carcinoma or metastatic liver disease

You may qualify if:

  • HCC or metastatic liver disease
  • Candidate for radioembolization or chemoembolization

You may not qualify if:

  • Pregnant
  • Iodine allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, 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

Study Officials

  • Mark Supanich, PH.D.

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 11, 2014

Study Start

November 1, 2014

Primary Completion

July 1, 2019

Study Completion

July 1, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

US(1)