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Adult Liver CarcinomaPhase 2NCT02695628

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

A Phase 2 study testing 18F-Fluoromisonidazole, Arterial Embolization and Computed Tomography in people with Adult Liver Carcinoma and Liver Cirrhosis, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Adult Liver Carcinoma, Liver Cirrhosis
What is being tested?
18F-Fluoromisonidazole, Arterial Embolization and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
13 Sep 2016to 31 Oct 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Uncontrolled chronic illness such as hypertension, diabetes, or heart failure
  • Contraindication to CT or MRI contrast
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Palo Alto Healthcare System

    Palo Alto, California, 94304

Other trials in United States

About this study

Official title: Assessment of Treatment-Induced Tissue Hypoxia After Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Feasibility Study With [18F]FMISO PET/CT

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the variability of 18F FMISO uptake in hepatocellular carcinoma (HCC) tumors compared to normal liver after transcatheter arterial embolization by determining the difference in the mean of the maximum standardized uptake value (SUVmax) and tumor-to-liver ratio (TLR) of a region of normal liver and of up to 5 index tumors.

SECONDARY OBJECTIVES:

  1. Determine if areas of tumor recurrence as determined by CT or magnetic resonance imaging (MRI) within a 6 month period after transcatheter arterial embolization show evidence of increased 18F FMISO labeling on the initial post treatment 18F FMISO PET/CT.

II. Determine the variability in SUVmax and TLR of untreated (non embolized) HCC lesions compared to normal liver by determining the difference in the mean of the SUVmax and TLR of normal liver and tumor.

III. Determine any toxicities related to [18F]FMISO use for PET/CT.

OUTLINE:

Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole intravenously (IV) and undergo PET/CT scans within 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.

After completion of treatment, patients are followed up at 2 and 3 months.

Being tested
18F-Fluoromisonidazole, Arterial Embolization, Computed Tomography, Positron Emission Tomography
Medical subject headings
Carcinoma, Hepatocellular, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-FluoromisonidazoleDrug

    Also called 18F-MISO, 18F-Misonidazole, FMISO

    Undergo [18F] FMISO PET/CT

  • Arterial EmbolizationProcedure or surgery

    Also called TAE, Transarterial Embolization

    Undergo transcatheter arterial embolization

  • Computed TomographyDiagnostic test

    Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography

    Undergo [18F] FMISO PET/CT

  • Positron Emission TomographyDiagnostic test

    Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan

    Undergo [18F] FMISO PET/CT

Study groups in NCT02695628
Study groupRoleWhat they receive
Diagnostic (18F-fluoromisonidazole, PET/CT, embolization)ExperimentalPatients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.
Receives: Drug: 18F-Fluoromisonidazole; Procedure: Arterial Embolization; Diagnostic Test: Computed Tomography; Diagnostic Test: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    All participants undergo transcatheter arterial embolization (TACE) and 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans were conducted. Maximum standardized uptake value (SUVmax) were determined at the tumor lesion and in normal tissue, represented by liver. The variability of 18F-FMISO uptake in hepatocellular carcinoma (HCC) tumors post-TACE was assessed as the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR). The outcome is reported as the mean TLR, with standard deviation.

    Measured: 24 hours

Secondary outcomes (2)

  1. Maximum Standardized Uptake Value (SUVmax) at Lesion Sites With and Without Tumor Recurrence

    Follow-up 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans were to be conducted within 6 months or at the time of tumor recurrence. Maximum standardized uptake value (SUVmax) were determined at the tumor lesion and in normal tissue, represented by liver. The variability of 18F-FMISO uptake at the hepatocellular carcinoma (HCC) tumor lesion site post-TACE was assessed as the mean difference in the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR), between lesions that recurred, and those that did not. The outcome is reported as the mean TLR, with standard deviation.

    Measured: Up to 6 months

  2. Adverse Events Related to 18F-fluoromisonidazole (18F-FMISO)

    Toxicity to 18F-fluoromisonidazole (18F-FMISO) was assessed by the number of adverse events that occurred within 18 hours of administration (about 10 half-lives), that were also unanticipated and related to 18F-FMISO. The outcome is reported as the number of adverse events that were unanticipated and related to 18F-FMISO, a number without dispersion.

    Measured: 18 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2016 (estimated)
  2. Study start13 Sep 2016
  3. Primary completion30 Apr 2018
  4. Study completion31 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02695628
Sponsor's protocol ID
IRB-29768
Other IDs
NCI-2016-00041, HEP0055, P30CA124435
Status last verified
Jan 2024
First submitted
24 Feb 2016
Last updated
31 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shah RP, Laeseke PF, Shin LK, Chin FT, Kothary N, Segall GM. Limitations of Fluorine 18 Fluoromisonidazole in Assessing Treatment-induced Tissue Hypoxia after Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Prospective Pilot Study. Radiol Imaging Cancer. 2022 May;4(3):e210094. doi: 10.1148/rycan.210094.

    PubMed 35485937

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 18F-Fluoromisonidazole, Arterial Embolization and Computed Tomography in people with Adult Liver Carcinoma and Liver Cirrhosis, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02695628, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.

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