Hepatic and Renal Thermography Using Magnetic Resonance Imaging

NCT ID: NCT01197820

Last Updated: 2012-06-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-05-31

Brief 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. 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.

Conditions

Liver Tumors; Kidney Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Arm 1

30 patients with liver tumour and 15 patients with kidney tumour will be enrolled.

Group Type: EXPERIMENTAL

MRI

Intervention Type: DEVICE

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

Interventions

MRI

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Tumours of the liver dome
• Deprived of their liberty by court
• Pregnant woman
• Contraindication to MRI examination
• Contraindication to including gadolinium salts injection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hervé TRILLAUD, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Service de radiologie - Hôpital PELLEGRIN - CHU de Bordeaux

Bordeaux, , France

Service of medical Imaging St André Hospital - CHU de BORDEAUX

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2010/11

Identifier Type: -

Identifier Source: org_study_id