Liver TumorsTHeR-IRMNCT01197820
Hepatic and Renal Thermography Using Magnetic Resonance Imaging
A study testing MRI in people with Liver Tumors and Kidney Carcinoma, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
Several technological challenges exist to apply Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) for treatment of liver or kidney in particular challenges related to the motion of these organs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Tumors, Kidney Carcinoma
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2010to May 2011
- Phase
- Interventional
- 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
- Liver tumors treated or not : HCC, liver metastases of colorectal cancer, hepatocellular adenoma, focal and nodular hyperplasia,
- Kidney tumors : carcinoma
- more than 18 years old
Who cannot join
- Tumours of the liver dome
- Deprived of their liberty by court
- Pregnant woman
- Contraindication to MRI examination
- Contraindication to including gadolinium salts injection
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de radiologie - Hôpital PELLEGRIN - CHU de Bordeaux
Bordeaux, 33000
Service of medical Imaging St André Hospital - CHU de BORDEAUX
Bordeaux, 33075
About this study
Several technological challenges exist to apply Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) for treatment of liver or kidney in particular challenges related to the motion of these organs. This study tests a new software to improve thermometry accuracy in mobile organs in patients with liver or kidney tumors. In the same time, the trajectory of the target in 3D is analyzed.
Read the detailed description
Liver and kidney tumors represent a major health problem because most patients are unsuitable for curative treatment with surgery. Thus, percutaneous ablation, using radio frequency (RF), is preferred : an interstitial electrode that delivers alternative current is placed into the tissue. Consequently, the development of an accurate and completely non-invasive method based on MR guided HIFU treatment is of particular interest since the energy source is located outside the body. There is no incision. For the patient, it provides a treatment option with reduced trauma and improved quality of life, and for the society, it provides reduced hospitalization time and reduced costs.
MRgHIFU has already been tested clinically in tumors of immobilized tissues as uterine leiomyoma. However, several technological challenges exist to apply it for treatment of the liver or the kidney especially challenges related to the motions of these organs. In order to improve the therapeutic efficiency and the safety of the intervention, real time mapping of temperature and thermal dose appear to offer the best strategy to optimize such interventions and provide clinical therapy endpoints. Among imaging modalities, MRI Proton Resonance Frequency based method appears to be the ideal tool for temperature mapping.
One major drawback of PRF thermometry is its high sensitivity to motion. Therefore motion correction is necessary to use PRF thermometry in mobile organs such as the liver or kidneys. To correct artefacts generated in temperature maps by periodical organ motion, a new technique was developed in the IMF lab of Bordeaux University Hospital.
The primary outcome of this study is to evaluate the precision of multiplanar MR imaging with real time motion compensation in hepatic or renal tumour patient.
Secondary outcomes are :
- Characterization of 3d movements of the tumour and test if imaging is improved when the imaging plan contains the main axis of movement.
- Ballistic: we need to identify all anatomical structures which are in the way of the HIFU beam in order to define the types of tumour suitable for future treatments
- Another outcome is to define what modifications are needed in order to treat patients such as depth of treatment, power level. We also need to see the target, ribs, and the transducer in order to evaluate the number of transducer elements to be turned off during treatment.
- Conditions
- Liver Tumors, Kidney Carcinoma
- Being tested
- MRI
- Keywords
- HIFU, mobile organs, thermometry, MR, liver, kidney, cancer, Liver tumors, kidney carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular, Carcinoma, Renal Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Patients will have a regular hepatic or kidney MRI investigation; we will add our sequences on their initial protocol. At first, one thermometry sequence is performed before angular correction is achieved with the following parameters: FOV=300 mm, matrix=96*96, TE/TR=18/72 ms, 67 lines/TR, Sense factor=1.4, 5 slices (4 coronal et 1 sagittal), 30° Flip angle.
In order to determine the main direction of motion, a set of 200 images are acquired during motion with two interleaved orthogonal slices (one coronal and one sagittal) centered on the region of interest, with the read out direction aligned with the head-feet direction. True-fisp images are acquired during 40 seconds with the following parameters: FOV=400 mm, matrix=128*109, TE/TR=1.2/2.43 ms, 60° flip angle, and 6 mm slice thickness.
Then the tested software proposes an angular correction to minimize out of plane motion. For each set of orientations, MR thermometry is performed
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 30 patients with liver tumour and 15 patients with kidney tumour will be enrolled. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature standard deviation
To test the ability of this method to improve thermometry accuracy, temperature standard deviations will be studied. Indeed, temperature standard deviations reflect thermometry inaccuracy in absence of temperature variations. Temperature standard deviation in each pixel will be measured over a temporal window. Two regions of interest (ROI) determined by the operator will be considered: the first one in the tumor, the second one for the whole organ.
Measured: Duration of MRI specific sequence (15 min)
Secondary outcomes (3)
Characterization of tumor motion in 3D during respiratory cycles
To characterize tumor motion in the 3 dimensions during respiratory cycles :
To study the ability of this approach to determinate the 3D trajectory of a target, motion projections on three orthogonal axes will be analyzed from the MRI two orthogonal slices. If the motion can be assimilated to a rectilinear displacement, there will be amplitude minimization after angular correction.
Measured: Duration of MRI specific sequence (15 min)
Improve of MRgHIFU shooting ballistics:
we need to see all anatomical structures in the path of the HIFU cone. Depth of the tumour, number of ribs in the pathway, presence of sensitive organ in the pathway or in PTV vicinity will be recorded
Measured: Duration of MRI specific sequence (15 min)
HIFU platform improvements
To define what improvements are needed on the HIFU platform in order to enhance its therapeutical abilities (depth of treatment, power level…) Amount of transducer's elements masked by rib's shadow, calculation of power level required for treatment, required number of HIFU transducer elements to be turn-off will be calculated.
Measured: Duration of MRI specific sequence (15 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé TRILLAUD, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197820
- Sponsor's protocol ID
- CHUBX 2010/11
- Acronym
- THeR-IRM
- Status last verified
- Jun 2012
- First submitted
- 2 Sep 2010
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic and Renal Thermography Using Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01197820
- Acronym / sponsor ID
- THeR-IRM / CHUBX 2010/11
- Conditions
- Liver Tumors, Kidney Carcinoma
- Keywords
- HIFU, mobile organs, thermometry, MR, liver, kidney, cancer, Liver tumors, kidney carcinoma
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Sep 2010 (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.
Several technological challenges exist to apply Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) for treatment of liver or kidney in particular challenges related to the motion of these organs. This study tests a new software to improve thermometry accuracy in mobile organs in patients with liver or kidney tumors. In the same time, the trajectory of the target in 3D is analyzed.
Detailed description
Liver and kidney tumors represent a major health problem because most patients are unsuitable for curative treatment with surgery. Thus, percutaneous ablation, using radio frequency (RF), is preferred : an interstitial electrode that delivers alternative current is placed into the tissue. Consequently, the development of an accurate and completely non-invasive method based on MR guided HIFU treatment is of particular interest since the energy source is located outside the body. There is no incision. For the patient, it provides a treatment option with reduced trauma and improved quality of life, and for the society, it provides reduced hospitalization time and reduced costs.
MRgHIFU has already been tested clinically in tumors of immobilized tissues as uterine leiomyoma. However, several technological challenges exist to apply it for treatment of the liver or the kidney especially challenges related to the motions of these organs. In order to improve the therapeutic efficiency and the safety of the intervention, real time mapping of temperature and thermal dose appear to offer the best strategy to optimize such interventions and provide clinical therapy endpoints. Among imaging modalities, MRI Proton Resonance Frequency based method appears to be the ideal tool for temperature mapping.
One major drawback of PRF thermometry is its high sensitivity to motion. Therefore motion correction is necessary to use PRF thermometry in mobile organs such as the liver or kidneys. To correct artefacts generated in temperature maps by periodical organ motion, a new technique was developed in the IMF lab of Bordeaux University Hospital.
The primary outcome of this study is to evaluate the precision of multiplanar MR imaging with real time motion compensation in hepatic or renal tumour patient.
Secondary outcomes are :
- Characterization of 3d movements of the tumour and test if imaging is improved when the imaging plan contains the main axis of movement.
- Ballistic: we need to identify all anatomical structures which are in the way of the HIFU beam in order to define the types of tumour suitable for future treatments
- Another outcome is to define what modifications are needed in order to treat patients such as depth of treatment, power level. We also need to see the target, ribs, and the transducer in order to evaluate the number of transducer elements to be turned off during treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: MRI30 patients with liver tumour and 15 patients with kidney tumour will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Liver tumors treated or not : HCC, liver metastases of colorectal cancer, hepatocellular adenoma, focal and nodular hyperplasia,
- Kidney tumors : carcinoma
- more than 18 years old
Key exclusion criteria (5 listed)
- Tumours of the liver dome
- Deprived of their liberty by court
- Pregnant woman
- Contraindication to MRI examination
- Contraindication to including gadolinium salts injection
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 |
|---|---|---|
| MRIPatients will have a regular hepatic or kidney MRI investigation; we will add our sequences on their initial protocol. At first, one thermometry sequence is performed before angular correction is achieved with the following parameters: FOV=300 mm, matrix=96*96, TE/TR=18/72 ms, 67 lines/TR, Sense factor=1.4, 5 slices (4 coronal et 1 sagittal), 30° Flip angle. In order to determine the main direction of motion, a set of 200 images are acquired during motion with two interleaved orthogonal slices (one coronal and one sagittal) centered on the region of interest, with the read out direction aligned with the head-feet direction. True-fisp images are acquired during 40 seconds with the following parameters: FOV=400 mm, matrix=128*109, TE/TR=1.2/2.43 ms, 60° flip angle, and 6 mm slice thickness. Then the tested software proposes an angular correction to minimize out of plane motion. For each set of orientations, MR thermometry is performed | Device | Arm 1 |
Primary outcome
Temperature standard deviation
Time frame: Duration of MRI specific sequence (15 min)
To test the ability of this method to improve thermometry accuracy, temperature standard deviations will be studied. Indeed, temperature standard deviations reflect thermometry inaccuracy in absence of temperature variations. Temperature standard deviation in each pixel will be measured over a temporal window. Two regions of interest (ROI) determined by the operator will be considered: the first one in the tumor, the second one for the whole organ.
3 secondary outcomes
Characterization of tumor motion in 3D during respiratory cycles
Time frame: Duration of MRI specific sequence (15 min)
Improve of MRgHIFU shooting ballistics:
Time frame: Duration of MRI specific sequence (15 min)
HIFU platform improvements
Time frame: Duration of MRI specific sequence (15 min)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
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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.
Hervé TRILLAUD, Pr principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Liver Tumors and Kidney Carcinoma, run by University Hospital, Bordeaux at 2 sites in France.
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 3 inclusion and 5 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 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
Are results available for this study?
The study was stopped early. 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?
Temperature standard deviation (time frame: Duration of MRI specific sequence (15 min)). 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 14 Jun 2012.