Hepatocellular CarcinomaEarly Phase 1NCT01968629
24hr Imaging Of HCC After EOVIST
A Early Phase 1 study testing Eovist in people with Hepatocellular Carcinoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this research study, the investigators are looking to see if MR imaging with Eovist performed 24 hours after the injection of Eovist helps improve the identification and characterization of focal liver tumors. 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?
- Eovist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jul 2015
- 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
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have histologically or cytologically confirmed hepatocellular carcinoma OR have an imaging study that demonstrates a focal hepatic lesion with imaging features diagnostic of hepatocellular carcinoma.
- Participants must be scheduled to undergo an Eovist-enhanced MRI of the liver as a part of their standard of care.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with MRI.
- Because no dosing or adverse event data are currently available on the use of Eovist in participants <18 years of age, and because HCC is exceedingly rare in the pediatric population, children are excluded from this study.
- The effects of Eovist on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Participants who have had chemotherapy, radiofrequency ablation, microwave ablation, chemo-embolization, or radiotherapy within 4 weeks prior to entering the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Eovist.
- Patients with glomerular filtration rates < 30 mL/min/1.73m2.
- Patients who are unable to undergo MRI imaging.
- Patients who are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
Official title: Pilot Study of Delayed, 24 Hour Imaging of Hepatocellular Carcinoma Following the Administration of the Hepatobiliary MRI Contrast Agent Gadolinium Ethoxybenzyl Dimeglumine (Eovist)
In this research study, the investigators are looking to see if MR imaging with Eovist performed 24 hours after the injection of Eovist helps improve the identification and characterization of focal liver tumors.
Read the detailed description
Before the research starts (screening): After signing the consent form, the participant will be asked to undergo some screening tests or procedures to find out if they can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that the participant does not take part in the research study. If the participants has had some of these tests or procedures recently, they may or may not have to be repeated.
- A medical history, which includes questions about the participant's health, current medications, and any allergies.
- An assessment of your tumor by X-ray, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans.
If these tests show that the participant is eligible to participate in the research study, the participant will begin the study. If the participant does not meet the eligibility criteria, they will not be able to participate in this research study.
After the screening procedures confirm that the the participant is eligible to participate in the research study:
In this research study, the investigators are looking to see if MR imaging with Eovist performed 24 hours after the injection of Eovist helps improve the identification and characterization of focal liver tumors. Currently, standard Eovist-enhanced MRI examinations include imaging up to 20 minutes after the injection of Eovist. The participant will undergo a routine, standard of care Eovist MRI examination of the liver. The participant will then be asked to return on the following day so that a repeat MRI examination may be performed at approximately 24 hours after your dose of Eovist. No additional injections will be performed on the 2nd day of imaging.
Planned Follow-up:
The investigators will follow the participant through the completion of their 24 hour MRI examination.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Eovist
- Keywords
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EovistDrug
Also called gadolinium ethoxybenzyl dimeglumine
| Study group | Role | What they receive |
|---|---|---|
| Eovist at 24 Hour Delayed Imaging | Experimental | This study will evaluate uptake of the hepatobiliary magnetic resonance imaging (MRI) contrast agent gadolinium ethoxybenzyl dimeglumine, or Eovist (Bayer Imaging, Wayne, NJ) within hepatocellular carcinomas (HCCs) at delayed, 24 hour imaging. The recommended dose of Eovist is 0.1 mL/kg, or 0.025 mmol/kg. Receives: Drug: Eovist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate the percent absolute enhancement of HCCs following Eovist administration at multiple phases
The primary objective is to calculate the percent absolute enhancement of HCCs following Eovist administration at multiple phases: arterial enhancement, portal venous enhancement, hepatobiliary enhancement, and late washout enhancement.All but the final phase of imaging are performed as part of routine clinical care and occur within the first 20 minutes. This study will investigate the behavior of HCCs with regards to Eovist enhancement at a late washout phase, which occurs after 24 hours. The primary outcome is evidence of absolute enhancement within HCC at the late washout phase.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: No eligible subject enrolled
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 Massachusetts General HospitalThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mukesh Harisinghani, MD, Massachusetts General Hospital
- Investigators
- Mukesh Harisinghani, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968629
- Sponsor's protocol ID
- 13-386
- Status last verified
- Sep 2015
- First submitted
- 20 Oct 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Delayed, 24 Hour Imaging of Hepatocellular Carcinoma Following the Administration of the Hepatobiliary MRI Contrast Agent Gadolinium Ethoxybenzyl Dimeglumine (Eovist)
- ClinicalTrials.gov ID
- NCT01968629
- Acronym / sponsor ID
- 13-386
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No eligible subject enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Oct 2013 (estimated)
- 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.
In this research study, the investigators are looking to see if MR imaging with Eovist performed 24 hours after the injection of Eovist helps improve the identification and characterization of focal liver tumors.
Detailed description
Before the research starts (screening): After signing the consent form, the participant will be asked to undergo some screening tests or procedures to find out if they can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that the participant does not take part in the research study. If the participants has had some of these tests or procedures recently, they may or may not have to be repeated.
- A medical history, which includes questions about the participant's health, current medications, and any allergies.
- An assessment of your tumor by X-ray, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans.
If these tests show that the participant is eligible to participate in the research study, the participant will begin the study. If the participant does not meet the eligibility criteria, they will not be able to participate in this research study.
After the screening procedures confirm that the the participant is eligible to participate in the research study:
In this research study, the investigators are looking to see if MR imaging with Eovist performed 24 hours after the injection of Eovist helps improve the identification and characterization of focal liver tumors. Currently, standard Eovist-enhanced MRI examinations include imaging up to 20 minutes after the injection of Eovist. The participant will undergo a routine, standard of care Eovist MRI examination of the liver. The participant will then be asked to return on the following day so that a repeat MRI examination may be performed at approximately 24 hours after your dose of Eovist. No additional injections will be performed on the 2nd day of imaging.
Planned Follow-up:
The investigators will follow the participant through the completion of their 24 hour MRI examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eovist at 24 Hour Delayed Imaging | Experimental | Drug: EovistThis study will evaluate uptake of the hepatobiliary magnetic resonance imaging (MRI) contrast agent gadolinium ethoxybenzyl dimeglumine, or Eovist (Bayer Imaging, Wayne, NJ) within hepatocellular carcinomas (HCCs) at delayed, 24 hour imaging. The recommended dose of Eovist is 0.1 mL/kg, or 0.025 mmol/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have histologically or cytologically confirmed hepatocellular carcinoma OR have an imaging study that demonstrates a focal hepatic lesion with imaging features diagnostic of hepatocellular carcinoma.
- Participants must be scheduled to undergo an Eovist-enhanced MRI of the liver as a part of their standard of care.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with MRI.
- Because no dosing or adverse event data are currently available on the use of Eovist in participants <18 years of age, and because HCC is exceedingly rare in the pediatric population, children are excluded from this study.
Key exclusion criteria (6 listed)
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Participants who have had chemotherapy, radiofrequency ablation, microwave ablation, chemo-embolization, or radiotherapy within 4 weeks prior to entering the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Eovist.
- Patients with glomerular filtration rates < 30 mL/min/1.73m2.
- Patients who are unable to undergo MRI imaging.
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 |
|---|---|---|
| EovistAlso: gadolinium ethoxybenzyl dimeglumine | Drug | Eovist at 24 Hour Delayed Imaging |
Primary outcome
Calculate the percent absolute enhancement of HCCs following Eovist administration at multiple phases
Time frame: 24 hours
The primary objective is to calculate the percent absolute enhancement of HCCs following Eovist administration at multiple phases: arterial enhancement, portal venous enhancement, hepatobiliary enhancement, and late washout enhancement.All but the final phase of imaging are performed as part of routine clinical care and occur within the first 20 minutes. This study will investigate the behavior of HCCs with regards to Eovist enhancement at a late washout phase, which occurs after 24 hours. The primary outcome is evidence of absolute enhancement within HCC at the late washout phase.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
Mukesh Harisinghani, MD principal investigator
Massachusetts General Hospital
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 Eovist in people with Hepatocellular Carcinoma, run by Massachusetts General Hospital 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 7 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: withdrawn, as of the sponsor's last update on 23 Sep 2015. 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 withdrawn before enrolling participants, so there are no results.
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?
Calculate the percent absolute enhancement of HCCs following Eovist administration at multiple phases (time frame: 24 hours). 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 23 Sep 2015.