Hepatic and Renal Thermography Using Magnetic Resonance Imaging

NCT01197820 | Terminated

• 1 other identifier: CHUBX 2010/11
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Liver Tumors; Kidney Carcinoma

Keywords

HIFU; mobile organs; thermometry; MR; liver; kidney; cancer; Liver tumors, kidney carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Duration of MRI specific sequence (15 min)

Secondary Outcomes (3)

• Characterization of tumor motion in 3D during respiratory cycles

  Duration of MRI specific sequence (15 min)

• Improve of MRgHIFU shooting ballistics:

  Duration of MRI specific sequence (15 min)

• HIFU platform improvements

  Duration of MRI specific sequence (15 min)

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Device: MRI

Interventions

MRI 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

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

Service de radiologie - Hôpital PELLEGRIN - CHU de Bordeaux

Bordeaux, 33000, France

Location

Service of medical Imaging St André Hospital - CHU de BORDEAUX

Bordeaux, 33075, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Carcinoma, Renal Cell; Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Hervé TRILLAUD, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 9, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

FR (2)