Carcinoma, HepatocellularNCT03088423
HCC Response Assessment by MRI After SBRT
An observational study of Carcinoma, Hepatocellular, run by Institut de Cancérologie de Lorraine.
Trial summary
The aim of this work was to describe SBRT different presentations, to study predictive factors for tumor responses following treatment, and to compare tumor response assessments according to the Response Evaluation Criteria Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- SBRT delivers high dose selective irradiation with millimeter precision to a small volume. The Cyberknife® is a robotic SBRT dedicated device that can deliver 100 to 200 photobeams to the target
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2011to 1 Feb 2015
- Phase
- Observational
- 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
Study population: Patients records were extracted from the electronic health record system of Institut de Cancérologie de Lorraine
- Inclusion Criteria: the standard criteria for treating HCC patients with SBRT : an Eastern Cooperative Oncology Group (ECOG) score of 2, inoperable tumors (e.g. the patient being unfit for surgery, or tumor-related contraindications), and a maximum tumor diameter of 6 cm. The HCC diagnosis could be histological or based on the radiological criteria of the American Association for the Study of Liver Diseases (AASLD)
- Exclusion Criteria:no follow-up by MR imaging
About this study
Official title: Tumor Response Assessment by MRI Following Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma
The aim of this work was to describe SBRT different presentations, to study predictive factors for tumor responses following treatment, and to compare tumor response assessments according to the Response Evaluation Criteria
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- SBRT delivers high dose selective irradiation with millimeter precision to a small volume. The Cyberknife® is a robotic SBRT dedicated device that can deliver 100 to 200 photobeams to the target
- Keywords
- MRI, Stereotactic body radiation therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT delivers high dose selective irradiation with millimeter precision to a small volume. The Cyberknife® is a robotic SBRT dedicated device that can deliver 100 to 200 photobeams to the targetRadiation
Seven to ten days before the scheduled CT, 2-4 fiducial markers were implanted percutaneously 2 to 5 cm next to the lesion under sonographic guidance following administration of local anesthesia, thus allowing real-time tracking during treatment. The total dose delivered was 45 Gy on the 80% isodose, in three fractions over 10 days. Gross tumor volume (GTV) was defined as the tumor mass that could be discerned by diagnostic imaging. An isotropic margin of 5 mm was added to account for the microscopic extension (clinical target volume, CTV) and another 3 mm margin was added to compensate for uncertainties regarding the position (previsional target volume, PTV)
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response assessments
The tumor response was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Within the 24 months after SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 Oct 2011
- Primary completion1 Apr 2013
- Study completion1 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088423
- Sponsor's protocol ID
- 2013_ICL_0001
- Status last verified
- Mar 2017
- First submitted
- 16 Mar 2017
- Last updated
- 23 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Response Assessment by MRI Following Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03088423
- Acronym / sponsor ID
- 2013_ICL_0001
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- MRI, Stereotactic body radiation therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 1 Apr 2013 (actual)
- Study completion
- 1 Feb 2015 (actual)
- First posted
- 23 Mar 2017 (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 aim of this work was to describe SBRT different presentations, to study predictive factors for tumor responses following treatment, and to compare tumor response assessments according to the Response Evaluation Criteria
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients records were extracted from the electronic health record system of Institut de Cancérologie de Lorraine
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 |
|---|---|---|
| SBRT delivers high dose selective irradiation with millimeter precision to a small volume. The Cyberknife® is a robotic SBRT dedicated device that can deliver 100 to 200 photobeams to the targetSeven to ten days before the scheduled CT, 2-4 fiducial markers were implanted percutaneously 2 to 5 cm next to the lesion under sonographic guidance following administration of local anesthesia, thus allowing real-time tracking during treatment. The total dose delivered was 45 Gy on the 80% isodose, in three fractions over 10 days. Gross tumor volume (GTV) was defined as the tumor mass that could be discerned by diagnostic imaging. An isotropic margin of 5 mm was added to account for the microscopic extension (clinical target volume, CTV) and another 3 mm margin was added to compensate for uncertainties regarding the position (previsional target volume, PTV) | Radiation | – |
Primary outcome
tumor response assessments
Time frame: Within the 24 months after SBRT
The tumor response was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by Institut de Cancérologie de Lorraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
tumor response assessments (time frame: Within the 24 months after SBRT). 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 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.