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Image quality on the MR-HIFU breast system.


- candidate number10288
- NTR NumberNTR3050
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-aug-2011
- Secondary IDsNL35059.041.11 CCMO
- Public TitleImage quality on the MR-HIFU breast system.
- Scientific TitleImage quality of MR-Imaging on the MR-High Intensity Focused Ultrasound breast system.
- ACRONYM
- hypothesisThis is a single center, prospective study to assess the quality of the MR images acquired on the MR-HIFU breast system in volunteers and patients with a fibroadenoma, by comparing images acquired on the MR-HIFU breast system with images acquired using comparable imaging techniques on a conventional 3-Tesla MRI scanner.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Healthy elderly , MR-High Intensity Focused Ultrasound, Fibroadenoma
- Inclusion criteriaInclusion criteria for volunteers:
1. Women;
2. Age ≥ 18 years;
3. Weight < 80 kg;
4. Physical fitness to lie in the MRI scanner for a maximum duration of 1 hour.

Inclusion criteria for patients with fibroadenomas:
1. Women;
2. Age ≥ 18 years;
3. Weight < 80 kg;
4. Physical fitness to lie in the MRI scanner for a maximum duration of 1 hour;
5. One or more histological proven fibroadenomas.
- Exclusion criteriaExclusion criteria for volunteers and patients with fibroadenomas:
1. Contra-indications for MRI scanning according to the guidelines of the hospital;
2. Pregnant or lactating women;
3. Volunteers and patients who donít want to be informed about unexpected findings.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate1-mrt-2012
- Target number of participants30
- InterventionsTwo MRI scans: One on the MR-HIFU breast system and one MRI scan in a conventional 3-Tesla MRI scanner.
- Primary outcome1. Image quality --> assessed by a score based on delineation of anatomical structures contrasts, SNR and artefacts of both MRI scans;
2. Lesion descriptors of the BI-RADS lexicon in patients with a fibroadenoma --> described by shape and margin of the lesion and other findings on the MRI scans (e.g. edema, lymphadenopathy, skin thickening).
- Secondary outcome1. Geometric deformation in breasts with different sizes --> assessed by overlaying the two MRI scans and assess whether there is deformation and assess the variety of deformation in breasts;
2. Size of fibroadenoma --> assessed by scoring the maximum diameter of the fibroadenoma in 3 orthogonal planes (MaxTrans, MaxSag, MaxCor) on both MRI scans;
3. Relative position of the fibroadenoma --> assessed by measuring the shortest distance from the fibroadenoma to the musculus pectoralis, the chest wall and the skin in 3 orthogonal planes (MaxTrans, MaxSag, MaxCor) on both MRI scans.
- TimepointsTwo MRI scans (each with a maximal duration of one hour) during one extra visit to the UMC Utrecht.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. Laura Merckel
- CONTACT for SCIENTIFIC QUERIESMD. Laura Merckel
- Sponsor/Initiator University Medical Center Utrecht, Department of Radiology
- Funding
(Source(s) of Monetary or Material Support)
Center for Translational Molecular Medicine (CTMM)
- PublicationsN/A
- Brief summaryBreast conserving therapy is standard of care for patients with localized breast cancer. Due to technological advances, there is growing interest in less invasive treatment techniques. Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) is a new and non-invasive treatment modality. Philips Healthcare developed a dedicated MR-HIFU breast system for ablation of tumors in the breast. Since MR images acquired on this new system are used for therapy planning, treatment guidance and evaluation of therapy results, it is important to assess the image quality that can be achieved on the dedicated MR-HIFU breast system.
- Main changes (audit trail)
- RECORD30-aug-2011 - 18-sep-2011


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