Hepatocellular CarcinomaEarly Phase 1NCT04150874
Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow Surrounding HAE
A Early Phase 1 study testing Lumason® in people with Hepatocellular Carcinoma and Liver Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to find out if a study agent called Lumason® microbubbles may be helpful for people with lesions in the liver. It is possible it may help determine an early response to radioembolization and/or help demonstrate radiation toxicity to the surrounding liver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer
- What is being tested?
- Lumason®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2020to 14 May 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Men and women >18 years of age.
- Histologically or cytologically confirmed hepatocellular carcinoma or meet imaging criteria for a diagnosis of hepatocellular carcinoma with tumor burden dominant in the liver.
- Participants must have measurable disease, by CT or MRI per mRECIST, not be a candidate for surgical resection based on unresectability, anatomy, anesthesia risk, patient preference.
- Serum Bilirubin ≤ 2.0
- Platelet count > 50,000/ul (corrected if needed)
- INR ≤ 1.5 (corrected if needed) 9. Serum creatinine < 2.0 mg/dl
Who cannot join
- Participants must be at least one month beyond prior chemotherapy, ablation or surgery, and have recovered from all therapy-associated toxicities.
- History of severe allergic reaction to intravenous contrast media (iodinated and gadoliniumbased) or any agents used during the embolization; participant cannot be medicated against allergic reaction prior to embolization or contrast enhanced ultrasound.
- History of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason® microbubbles
- Active infection
- Participants with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)
- Pregnancy or lactation. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Participants may not be receiving any other investigational agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow and the Surrounding Hepatic Parenchyma Before, During and After Hepatic Artery Embolization
The purpose of the study is to find out if a study agent called Lumason® microbubbles may be helpful for people with lesions in the liver. It is possible it may help determine an early response to radioembolization and/or help demonstrate radiation toxicity to the surrounding liver.
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Being tested
- Lumason®
- Keywords
- Hepatic Artery Embolization, Liver Metastases, Radioembolization
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumason®Diagnostic test
Hepatic artery embolization using standard of care radioembolization and assessment of tumor and hepatic parenchymal perfusion kinetics before, during and after treatment with standard of care iodinated contrast (at the time of Y90 radioembolization treatment) and standard of care follow-up with multiphase CT or MRI with the addition of study agent Lumason microbubbles for contrast-enhanced ultrasound (which will be performed concurrently with standard evaluation).
| Study group | Role | What they receive |
|---|---|---|
| Lumason Microbubbles | Experimental | Participants will receive an IV administrative of Lumason® microbubbles, prior to radioembolization. 2 doses of 2.5mL will be administered Receives: Diagnostic Test: Lumason® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Early Tumor Response
Dynamic CEUS imaging will demonstrate perfusion characteristics that will predict early tumor response to Transarterial Y90 embolization in Hepatocellular Carcinoma. A change in intra-tumoral arterial flow will be predictive of early response. This will be evaluated immediately following hepatic artery embolization (day 0), at 4 weeks (follow-up 1), 12 weeks (follow-up 2) and 24 weeks (follow-up 3). A modified RECIST will be used to measure early tumor response.
Measured: Base line up to 24 weeks
Secondary outcomes (1)
Number of Participants with Early Signs of Radiation Induced Liver Disease (RILD)
Dynamic CEUS imaging will demonstrate perfusion characteristics that will predict early signs of Radiation Induced Liver Disease (RILD) after Transarterial Y90 embolization in Hepatocellular Carcinoma. This will be evaluated immediately following hepatic artery embolization (day 0), at 4 weeks (follow-up 1), 12 weeks (follow-up 2) and 24 weeks (follow-up 3).
Measured: Base line up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start19 Feb 2020
- Primary completion14 May 2021
- Study completion14 May 2021
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa McGettigan, MD, Principal investigator, Moffitt Cancer CenterJennifer Sweeney, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150874
- Sponsor's protocol ID
- MCC-19974
- Status last verified
- Apr 2023
- First submitted
- 1 Nov 2019
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow and the Surrounding Hepatic Parenchyma Before, During and After Hepatic Artery Embolization
- ClinicalTrials.gov ID
- NCT04150874
- Acronym / sponsor ID
- MCC-19974
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Keywords
- Hepatic Artery Embolization, Liver Metastases, Radioembolization
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to find out if a study agent called Lumason® microbubbles may be helpful for people with lesions in the liver. It is possible it may help determine an early response to radioembolization and/or help demonstrate radiation toxicity to the surrounding liver.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumason Microbubbles | Experimental | Diagnostic Test: Lumason®Participants will receive an IV administrative of Lumason® microbubbles, prior to radioembolization. 2 doses of 2.5mL will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Men and women >18 years of age.
- Histologically or cytologically confirmed hepatocellular carcinoma or meet imaging criteria for a diagnosis of hepatocellular carcinoma with tumor burden dominant in the liver.
- Participants must have measurable disease, by CT or MRI per mRECIST, not be a candidate for surgical resection based on unresectability, anatomy, anesthesia risk, patient preference.
Key exclusion criteria (7 listed)
- Participants must be at least one month beyond prior chemotherapy, ablation or surgery, and have recovered from all therapy-associated toxicities.
- History of severe allergic reaction to intravenous contrast media (iodinated and gadoliniumbased) or any agents used during the embolization; participant cannot be medicated against allergic reaction prior to embolization or contrast enhanced ultrasound.
- History of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason® microbubbles
- Active infection
- Participants with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)
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 |
|---|---|---|
| Lumason®Hepatic artery embolization using standard of care radioembolization and assessment of tumor and hepatic parenchymal perfusion kinetics before, during and after treatment with standard of care iodinated contrast (at the time of Y90 radioembolization treatment) and standard of care follow-up with multiphase CT or MRI with the addition of study agent Lumason microbubbles for contrast-enhanced ultrasound (which will be performed concurrently with standard evaluation). | Diagnostic test | Lumason Microbubbles |
Primary outcome
Number of Participants with Early Tumor Response
Time frame: Base line up to 24 weeks
Dynamic CEUS imaging will demonstrate perfusion characteristics that will predict early tumor response to Transarterial Y90 embolization in Hepatocellular Carcinoma. A change in intra-tumoral arterial flow will be predictive of early response. This will be evaluated immediately following hepatic artery embolization (day 0), at 4 weeks (follow-up 1), 12 weeks (follow-up 2) and 24 weeks (follow-up 3). A modified RECIST will be used to measure early tumor response.
1 secondary outcome
Number of Participants with Early Signs of Radiation Induced Liver Disease (RILD)
Time frame: Base line up to 24 weeks
Results and safety
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Melissa McGettigan, MD principal investigator
Moffitt Cancer Center
Jennifer Sweeney, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lumason® in people with Hepatocellular Carcinoma and Liver Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 7 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 10 Apr 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
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?
Number of Participants with Early Tumor Response (time frame: Base line up to 24 weeks). 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 10 Apr 2023.