Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03990623

Conditions

Liver and Intrahepatic Bile Duct Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography Perfusion Imaging

Liver Biopsy

Study Details

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.

Conditions

Liver and Intrahepatic Bile Duct Carcinoma

Study ID

NCT03990623

Start date

Jul 21, 2018

Status verified date

Sep, 2022

Completion date

Apr 30, 2024

Anticipated

Primary completion date

Apr 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Design

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (CT perfusion scans, liver biopsy)

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.

Interventions

Computed Tomography Perfusion Imaging

Undergo perfusion CT

Liver Biopsy

Undergo liver biopsy

Primary outcome measure

  • Perfusion changes to the liver following portal vein embolization (PVE) [ Time Frame: Baseline up to 6 weeks post PVE ]

Central Contacts and Locations

Central contacts

Steven Y Huang, MD

713-794-1152syhuang@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Steven Y. Huang, MD

713-794-1152syhuang@mdanderson.org

Principal Investigator:

Steven Y. Huang, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 7, 2023

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2023-04-07.