Hepatocellular CarcinomaPhase 2NCT03303469
Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging
A Phase 2 study testing FMISO in people with Hepatocellular Carcinoma, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
[18F] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- FMISO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 6 Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Advanced Imaging Facility
Birmingham, Alabama, 35294
About this study
Official title: Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: [18F]Fluoromisonidazole (FMISO) Imaging
[18F] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE.
Read the detailed description
This Phase II study will investigate the utility of [18F] FMISO in patients with hepatocellular carcinoma (HCC). This trial is designed to test the hypothesis that PET determined [18F]FMISO uptake will indicate tumor hypoxia in patients with HCC treated with trans-arterial chemo-embolization (TACE). We anticipate that [18F] FMISO PET/CT will advance our understanding of the role of hypoxia in HCC prior to treatment and that this knowledge will help design newer combination therapeutic trials for better treatment outcomes. [18F] FMISO PET/CT provides three parameters, tissue hypoxic volume (HV), maximum tissue to blood uptake ratio (T:Bmax) and tumor blood flow. Both pre-and post-therapy images will be examined to investigate changes in these parameters during the course of TACE treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- FMISO
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMISODrug
FMISO PET/CT imaging at baseline
FMISODrug
FMISO PET/CT post TACE
FMISODrug
FMISO PET/CT post SBRT
| Study group | Role | What they receive |
|---|---|---|
| FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT) | Experimental | FMISO imaging at baseline, post-TACE and post-SBRT Receives: Drug: FMISO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET).
Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia
Measured: At baseline
Measure Changes in HCC Tumor Hypoxia and Blood Flow After Trans-arterial Chemoembolization (TACE), Prior to Radiotherapy.
Perform PET/CT imaging using FMISO post-TACE and prior to Stereotactic body radiation therapy (SBRT) to determine tumor hypoxia
Measured: 1 month post-TACE procedures and prior to SBRT
Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy
Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia
Measured: 1 month post-SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start30 Oct 2017
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
Why it stopped: study was terminated due to poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janis P. O'Malley, MD, University of Alabama at Birmingham
- Investigators
- Janis P O'Malley, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303469
- Sponsor's protocol ID
- F170519002
- Status last verified
- Feb 2021
- First submitted
- 13 Sep 2017
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: [18F]Fluoromisonidazole (FMISO) Imaging
- ClinicalTrials.gov ID
- NCT03303469
- Acronym / sponsor ID
- F170519002
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study was terminated due to poor enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
[18F] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE.
Detailed description
This Phase II study will investigate the utility of [18F] FMISO in patients with hepatocellular carcinoma (HCC). This trial is designed to test the hypothesis that PET determined [18F]FMISO uptake will indicate tumor hypoxia in patients with HCC treated with trans-arterial chemo-embolization (TACE). We anticipate that [18F] FMISO PET/CT will advance our understanding of the role of hypoxia in HCC prior to treatment and that this knowledge will help design newer combination therapeutic trials for better treatment outcomes. [18F] FMISO PET/CT provides three parameters, tissue hypoxic volume (HV), maximum tissue to blood uptake ratio (T:Bmax) and tumor blood flow. Both pre-and post-therapy images will be examined to investigate changes in these parameters during the course of TACE treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT) | Experimental | Drug: FMISOFMISO imaging at baseline, post-TACE and post-SBRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMISOFMISO PET/CT imaging at baseline | Drug | FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT) |
| FMISOFMISO PET/CT post TACE | Drug | FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT) |
| FMISOFMISO PET/CT post SBRT | Drug | FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT) |
Primary outcome
Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET).
Time frame: At baseline
Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia
Measure Changes in HCC Tumor Hypoxia and Blood Flow After Trans-arterial Chemoembolization (TACE), Prior to Radiotherapy.
Time frame: 1 month post-TACE procedures and prior to SBRT
Perform PET/CT imaging using FMISO post-TACE and prior to Stereotactic body radiation therapy (SBRT) to determine tumor hypoxia
Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy
Time frame: 1 month post-SBRT
Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janis P O'Malley, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FMISO in people with Hepatocellular Carcinoma, run by University of Alabama at Birmingham 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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 21 Feb 2021. 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 21 Feb 2021). 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?
Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET). (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2021.