NCT03990623

Brief Summary

This trial studies the use of computed tomography (CT) perfusion scans in detecting changes in blood flow to the liver after portal vein embolization in patients with liver cancer. CT perfusion scans use a standard contrast drug given by vein to measure blood flow to the liver. CT perfusion scans may predict the rate and amount of growth of new, healthy tissue on one side of the liver after a portal vein embolization and detect change to the size of the liver tumor as result of the procedure.

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
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

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

July 21, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

April 7, 2023

Status Verified

September 1, 2022

Enrollment Period

5.8 years

First QC Date

June 17, 2019

Last Update Submit

April 5, 2023

Conditions

Liver and Intrahepatic Bile Duct Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Perfusion changes to the liver following portal vein embolization (PVE)

    Will assess whether perfusion changes to the liver following PVE correlate with hypertrophy of the future liver remnant (FLR). Perfusion and FLR hypertrophy are two continuous variables. Each patient will serve as his/her own control. Perfusion to the liver (1) before PVE, (2) immediately after PVE, and (3) 3-6 weeks following PVE will be measured and compared. The changes in perfusion will be compared with FLR hypertrophy at the 3-6 week time point to assess correlation.

    Baseline up to 6 weeks post PVE

Secondary Outcomes (1)

  • Changes to tumor cellular proliferation following PVE

    Baseline up to 6 weeks post PVE

Study Arms (1)

Diagnostic (CT perfusion scans, liver biopsy)

EXPERIMENTAL

Prior to PVE, patients undergo CT perfusion scan of the liver and liver biopsy over 15 minutes. Patients undergo a second CT perfusion scan immediately after PVE and a third CT perfusion scan 3-6 weeks post PVE.

Radiation: Computed Tomography Perfusion ImagingProcedure: Liver Biopsy

Interventions

Computed Tomography Perfusion ImagingRADIATION

Undergo perfusion CT

Diagnostic (CT perfusion scans, liver biopsy)
Liver BiopsyPROCEDURE

Undergo liver biopsy

Also known as: Biopsy of Liver
Diagnostic (CT perfusion scans, liver biopsy)

Eligibility Criteria

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

You may qualify if:

  • Patients planned to undergo major liver resection for cancer who need PVE to increase the size of the FLR prior to surgery.
  • Patients who are able to understand and give consent to participate in the study.

You may not qualify if:

  • Pregnant or nursing.
  • Allergy to iodinated contrast which cannot be safely pre-medicated.
  • History of severe renal dysfunction (glomerular filtration rate \[GFR\] \< 30 mL/min/1.73 square meters). Patients with a GFR between 30-50 mL/min/1.73 square meters will receive the standard contrast-induced nephropathy prophylaxis at our institution (i.e. N-acetylcysteine and sodium bicarbonate \[150 mEq/L\] in D5W intravenous).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Steven Y Huang, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Y Huang, MD

CONTACT

713-794-1152syhuang@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2019

First Posted

June 19, 2019

Study Start

July 21, 2018

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

April 7, 2023

Record last verified: 2022-09

Locations

US(1)