Hepatocellular CarcinomaClinicIMPPACTNCT02745600
Clinical Intervention Modelling, Planning and Proof for Ablation Cancer Treatment
A study testing RFA therapy simulator in people with Hepatocellular Carcinoma and Liver Metastases, run by University of Leipzig at 4 sites in 4 countries.
Trial summary
The main objective of the project is to bring the existing radio frequency ablation (RFA) model for liver cancer treatment (Project IMPPACT, Grant No. 223877, completed in February 2012) into clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Metastases
- What is being tested?
- RFA therapy simulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2016to Mar 2017
- 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
- primary or secondary tumors of the liver
- consent of local tumor board stating RFA is best treatment option
- Maximum tumor diameter 3cm
- Maximum of 3 lesions
- Stable extrahepatic tumor manifestation without growth tendency including the possibility of therapy (e.g. bone, lung metastasis are no contraindication)
- If liver cirrhosis must be compensated Child-Pugh A or B
- written informed consent
Who cannot join
- Pregnancy and/or breastfeeding
- Severe anaphylactic reaction against iodine and/ or contrast agent
- Insufficient coagulation
- Splenectomy
- Insufficient kidney and thyroid gland function
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Austria1 site, 1 recruiting
- Recruiting
Medical University Graz
Graz, 8036
Rupert H. Portugaller, M.d.; PhD
Finland1 site, 1 recruiting
- Recruiting
University Hospital Turku
Turku, 20521
Roberto Blanco, M.D.; Ph.D.
Germany1 site, 1 recruiting
- Recruiting
Department of Diagnostic and Interventional Radiology, University Leipzig, Germany
Leipzig, Saxony, 04103
Martin Reinhardt, M.D., 004934197 ext. 16987, martin.reinhardt@medizin.uni-leipzig.de
Daniel Seider, M.D:, 004934197 ext. 16990, daniel.seider@medizin.uni-leipzig.de
Netherlands1 site, 1 recruiting
- Recruiting
Radbound Universität Nijmegen
Nijmegen, 6500HB
Jürger Fütterer, M.D.; Ph.D.
About this study
Official title: Clinical Intervention Modelling, Planning and Proof for Ablation Cancer Treatment (ClinicIMPPACT)
The main objective of the project is to bring the existing radio frequency ablation (RFA) model for liver cancer treatment (Project IMPPACT, Grant No. 223877, completed in February 2012) into clinical practice. Therefore the project will pursue the following objectives:
- to prove and refine the RFA model in a small clinical study; ii) to develop the model into a real-time patient specific RFA planning and support system for Interventional Radiologists (IR) under special consideration of their clinical workflow needs; iii) to establish a corresponding training procedure for IR's; iv) to evaluate the clinical practicality and benefit of the model for use in the routine workflow in a user survey and expert forum.
Read the detailed description
This ClinicIMPPACT proposal builds upon the success of the IMPPACT project (Grant No. 223877, completed in February 2012), which created a model for facilitating more accurate RFA treatment. This preliminary RFA model was tested in swine, with extensive histological workup, and in a clinical simulation study based on patient data, both of which reported relatively high correlations between estimated and actual tumor volumes. The mapping software for liver cancer RFA was developed through this project and provides a simulator for radiologists to plan, review and optimize procedures. Within IMPPACT, extensive experiments were performed on pigs and cells to develop a micro-scale cellular death model, which we used for calibrating the software. After porcine liver calibration, eight patient lesions were selected from a database of clinical procedures, and the planning software was used retrospectively to simulate interventions and predict lesion shapes. Predicted volumes were then compared against real thermal lesions, visualized and segmented in contrast-enhanced CT one month after ablation. These comparisons showed simulated and real lesion volumes to be acceptably matched after taking virtual tissue perfusion values into account. Some lesion shapes were mismatched, possibly due to inaccuracies in segmenting radiological images.
Treatment with RFA could be improved using a validated software solution to estimate lesion size and identify possible complications in advance-ideally, a solution which is adapted to real-time clinical requirements. However, the current state of the art involves long, hardware-intensive computing time (~5 hours), which is impractical for clinical use.
The main goal of this project is to develop a simulation tool, driven by a user-friendly, ergonomically optimized graphical user interface, to support the complex requirements of clinicians. Therefore, the working steps of this international project and its medical and technical partners are to accelerate simulation speed, optimize needle registration, and integrate patients' individual perfusion values into software calculations, as well as accurate validation techniques, to produce more sophisticated and reliable predictions. The software could also aid in offline planning and simulation and as an RFA teaching tool for radiologists. Its use in retrospective analysis should improve clinical follow up and scientific evaluation.
- Conditions
- Hepatocellular Carcinoma, Liver Metastases
- Being tested
- RFA therapy simulator
- Keywords
- RFA, Liver, Ablation Techniques, Treatment Simulation, Computer assisted 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.
RFA therapy simulatorDevice
Computer assisted RFA of liver tumors: Planning, simulation, and follow up,
| Study group | Role | What they receive |
|---|---|---|
| Software assisted RFA treatment | Other | Non-controlled, prospective, multicenter study arm, to evaluate RFA therapy simulation software. Receives: Device: RFA therapy simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the size and shape, using quantitative and semi-quantitative measures, of the real ablation zone one month after RFA treatment of liver tumors with the simulation results of the ClinicIMPPACT software.
For the primary endpoint, the investigators will compare lesions visualized by routine CT one month after ablation with their simulated counterparts to define the accuracy of the method itself. The coinciding volumes of the real RFA lesion and the simulated one will be determined by counting the number of matching voxels, i.e. voxels of simulation and recorded data, sharing the space coordinates, and dividing by the sum of the voxels of simulated and real lesions.
To define the accuracy of the simulation as a parameter, we introduce the following categories:
In comparison to the "real ablation" the simulation result would have been:
- much smaller II. comparable III. much larger b) The spatial coordinates of the "real ablation" differs from the simulated one I. Strongly II. Not strongly
Measured: All patients within 1 month follow up in the trial period
Comparison of the spatial coordiantes of the real ablation zone one month after RFA treatment of liver tumors with the simulation results of the ClinicIMPPACT software.
To define the accuracy of the simulation as a parameter, the investigators introduce the following categories:
The spatial coordinates of the "real ablation" differs from the simulated one I. Strongly II. Not strongly
Measured: All patients within 1 month follow up in the trial period
Secondary outcomes (3)
Duration/Efficiency of workflow steps measured in minutes
Duration of the simulation (minutes)
Measured: up to 60 minutes per lesion
Would the treatment protocol been influenced by the simulation results if it would have been known in advance by the treating doctor.
Influence Yes/No
- If yes, is there an expectable potential benefit for the patient due to an increase or decrease of the treatment protocol?
Measured: 12 months
Does the follow - up (3, 6 ,12months) imaging support the assumptions regarding local tumor control
Choice of one of the options below:
- The tumor is completely treated with sufficient safety margins, healthy tissue has been largely spared by the ablation and there is no locoregional recurrence visible in the follow - up imaging (= locoregional recurrence free - survival).
- The tumor (incl. safety margins) is completely treated, but lots of healthy tissue has been damaged with the risk of serious complications.
- The tumor is treated incompletely or there is a visable recurrent tumor in the follow up examination.
Measured: up to 24 months due to 12m follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionMar 2017 (estimated)
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.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz, University Medical Center Nijmegen, University of Turku
- Responsible party
- Principal investigator, Dr. med. Philipp Brandmaier, University of Leipzig
- Investigators
- Michael Moche, M.D., Principal investigator, Department of Diagnostic and Interventional Radiology, University Leipzig, Leipzig, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745600
- Sponsor's protocol ID
- 610886
- Acronym
- ClinicIMPPACT
- Status last verified
- Apr 2016
- First submitted
- 23 Mar 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Intervention Modelling, Planning and Proof for Ablation Cancer Treatment (ClinicIMPPACT)
- ClinicalTrials.gov ID
- NCT02745600
- Acronym / sponsor ID
- ClinicIMPPACT / 610886
- Conditions
- Hepatocellular Carcinoma, Liver Metastases
- Keywords
- RFA, Liver, Ablation Techniques, Treatment Simulation, Computer assisted therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Medical University of Graz, University Medical Center Nijmegen, University of Turku
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 20 Apr 2016 (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.
The main objective of the project is to bring the existing radio frequency ablation (RFA) model for liver cancer treatment (Project IMPPACT, Grant No. 223877, completed in February 2012) into clinical practice. Therefore the project will pursue the following objectives:
- to prove and refine the RFA model in a small clinical study; ii) to develop the model into a real-time patient specific RFA planning and support system for Interventional Radiologists (IR) under special consideration of their clinical workflow needs; iii) to establish a corresponding training procedure for IR's; iv) to evaluate the clinical practicality and benefit of the model for use in the routine workflow in a user survey and expert forum.
Detailed description
This ClinicIMPPACT proposal builds upon the success of the IMPPACT project (Grant No. 223877, completed in February 2012), which created a model for facilitating more accurate RFA treatment. This preliminary RFA model was tested in swine, with extensive histological workup, and in a clinical simulation study based on patient data, both of which reported relatively high correlations between estimated and actual tumor volumes. The mapping software for liver cancer RFA was developed through this project and provides a simulator for radiologists to plan, review and optimize procedures. Within IMPPACT, extensive experiments were performed on pigs and cells to develop a micro-scale cellular death model, which we used for calibrating the software. After porcine liver calibration, eight patient lesions were selected from a database of clinical procedures, and the planning software was used retrospectively to simulate interventions and predict lesion shapes. Predicted volumes were then compared against real thermal lesions, visualized and segmented in contrast-enhanced CT one month after ablation. These comparisons showed simulated and real lesion volumes to be acceptably matched after taking virtual tissue perfusion values into account. Some lesion shapes were mismatched, possibly due to inaccuracies in segmenting radiological images.
Treatment with RFA could be improved using a validated software solution to estimate lesion size and identify possible complications in advance-ideally, a solution which is adapted to real-time clinical requirements. However, the current state of the art involves long, hardware-intensive computing time (~5 hours), which is impractical for clinical use.
The main goal of this project is to develop a simulation tool, driven by a user-friendly, ergonomically optimized graphical user interface, to support the complex requirements of clinicians. Therefore, the working steps of this international project and its medical and technical partners are to accelerate simulation speed, optimize needle registration, and integrate patients' individual perfusion values into software calculations, as well as accurate validation techniques, to produce more sophisticated and reliable predictions. The software could also aid in offline planning and simulation and as an RFA teaching tool for radiologists. Its use in retrospective analysis should improve clinical follow up and scientific evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Software assisted RFA treatment | Other | Device: RFA therapy simulatorNon-controlled, prospective, multicenter study arm, to evaluate RFA therapy simulation software. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- primary or secondary tumors of the liver
- consent of local tumor board stating RFA is best treatment option
- Maximum tumor diameter 3cm
- Maximum of 3 lesions
- Stable extrahepatic tumor manifestation without growth tendency including the possibility of therapy (e.g. bone, lung metastasis are no contraindication)
Key exclusion criteria (5 listed)
- Pregnancy and/or breastfeeding
- Severe anaphylactic reaction against iodine and/ or contrast agent
- Insufficient coagulation
- Splenectomy
- Insufficient kidney and thyroid gland function
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 |
|---|---|---|
| RFA therapy simulatorComputer assisted RFA of liver tumors: Planning, simulation, and follow up, | Device | Software assisted RFA treatment |
Primary outcome
Comparison of the size and shape, using quantitative and semi-quantitative measures, of the real ablation zone one month after RFA treatment of liver tumors with the simulation results of the ClinicIMPPACT software.
Time frame: All patients within 1 month follow up in the trial period
For the primary endpoint, the investigators will compare lesions visualized by routine CT one month after ablation with their simulated counterparts to define the accuracy of the method itself. The coinciding volumes of the real RFA lesion and the simulated one will be determined by counting the number of matching voxels, i.e. voxels of simulation and recorded data, sharing the space coordinates, and dividing by the sum of the voxels of simulated and real lesions. To define the accuracy of the simulation as a parameter, we introduce the following categories: In comparison to the "real ablation" the simulation result would have been: I. much smaller II. comparable III. much larger b) The spatial coordinates of the "real ablation" differs from the simulated one I. Strongly II. Not strongly
Comparison of the spatial coordiantes of the real ablation zone one month after RFA treatment of liver tumors with the simulation results of the ClinicIMPPACT software.
Time frame: All patients within 1 month follow up in the trial period
To define the accuracy of the simulation as a parameter, the investigators introduce the following categories: The spatial coordinates of the "real ablation" differs from the simulated one I. Strongly II. Not strongly
3 secondary outcomes
Duration/Efficiency of workflow steps measured in minutes
Time frame: up to 60 minutes per lesion
Would the treatment protocol been influenced by the simulation results if it would have been known in advance by the treating doctor.
Time frame: 12 months
Does the follow - up (3, 6 ,12months) imaging support the assumptions regarding local tumor control
Time frame: up to 24 months due to 12m follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- 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.
Michael Moche, M.D. principal investigator
Department of Diagnostic and Interventional Radiology, University Leipzig, Leipzig, Germany
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFA therapy simulator in people with Hepatocellular Carcinoma and Liver Metastases, run by University of Leipzig at 4 sites in 4 countries.
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 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: status not confirmed, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Finland, Germany, Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Moche, M.D. (00493419717558, michael.moche@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the size and shape, using quantitative and semi-quantitative measures, of the real ablation zone one month after RFA treatment of liver tumors with the simulation results of the ClinicIMPPACT software. (time frame: All patients within 1 month follow up in the trial period). The study lists 2 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 22 Apr 2016.