CompletedPhase 2

[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer

United States5 participantsStarted 2016-09-13

Plain-language summary

This clinical trial studies how well 18F-fluoromisonidazole (\[18F\]FMISO) positron emission tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor. \[18F\]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that have a low level of oxygen, and the radiation given off by \[18F\]FMISO is picked up by a PET scan and this may help researchers learn whether changes occur in the tumors after treatment, which can help decide how well the treatment worked earlier than is currently possible

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Histopathologic or imaging and clinical features of tumor(s) diagnostic for hepatocellular carcinoma with at least one tumor \>= 1.5 cm; imaging features diagnostic for hepatocellular carcinoma will be defined as Liver Imaging Reporting and Data System (LIRADS) 4 or greater * Total bilirubin \< 3.0 * Child Pugh A or B * Tumor amenable to transcatheter arterial embolization * Able to provide informed consent Exclusion Criteria: * Uncontrolled large ascites * Main or segmental portal vein thrombosis * Locoregional treatment of hepatocellular carcinoma within the prior 3 months or chemotherapy within the previous 3 months * Inability or contraindication to undergo transcatheter arterial embolization * Inability to lay flat for at least 2 consecutive hours * Severe acute illness * Uncontrolled chronic illness such as hypertension, diabetes, or heart failure * Contraindication to CT or MRI contrast * Pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue

Timeframe: 24 hours

Trial details

NCT IDNCT02695628

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04-30

Results submitted2019-03-13

View on ClinicalTrials.gov More Adult Liver Carcinoma trials