Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging

Stopped early · Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

\[18F\] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE.

Key facts

Study ID

NCT03303469

Run by

University of Alabama at Birmingham

People needed

3

Starts

2017-10-30

Expected to finish

2021-01-06

Last updated by the study team

2021-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (> 18 years of age) patients with documented HCC tumor mass >3cm, who are scheduled to undergo TACE with additional selective internal radiation therapy (SIRT)
• The appropriate criteria for inclusion for this patient population are:
• Biopsy or radiological diagnosis of HCC (defined as Organ Procurement and Transplantation Network (OPTN*) Category 5 lesion either on CT or MRI)
• Scheduled for TACE (using doxorubicin-eluting beads) + SBRT
• Willingness to undergo PET/CT
• Able to lie on the imaging table for up to 1 hour.
• Able to provide signed informed consent.
• Women with childbearing potential must have a negative urine Beta-Human Chorionic Gonadotropin (β-hCG) test day of procedure

You may not qualify if…

• Estimated life expectancy <12 months or serious medical co-morbidities that would preclude definitive local therapy
• Unable to lie on the imaging table
• Age less than 18 years.
• Pregnancy or lactation
• Inability or unwillingness to provide informed consent.
• Weight >500 lbs (the weight limit of the tomograph gantry table)

Where it is running

• UAB Advanced Imaging Facility — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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