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van CCT (UK)

van CCT (UK)

Feasibility of ultra high field 7.0 Tesla MR Spectroscopy for monitoring neo-adjuvant therapy efficacy

- candidate number18168
- NTR NumberNTR4652
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jun-2014
- Secondary IDsNL36429.041.11 CCMO
- Public TitleFeasibility of ultra high field 7.0 Tesla MR Spectroscopy for monitoring neo-adjuvant therapy efficacy
- Scientific TitleFeasibility of ultra high field 7.0 Tesla MR Spectroscopy for monitoring neo-adjuvant therapy efficacy
- ACRONYMSpectro
- hypothesisMetabolic changes are thought to precede morphological or changes in tumor size. MR spectroscopy can monitor metabolic changes
- Healt Condition(s) or Problem(s) studiedBreast cancer, Neoadjuvant therapy
- Inclusion criteria- 18 year or older
- Female
- Neoadjuvant therapy for breast cancer
- Exclusion criteria- Prior surgery for malignancy to ipsilateral breast
- Karnofsky score =< 70
- Pregnant or lactating
- Other contraindications for MR
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 27-feb-2012
- planned closingdate31-dec-2014
- Target number of participants15
- Interventionsnone
- Primary outcomea) What changes in phospomonoester / phosphodiester ratio can be detected with 7T MRS during neo-adjuvant therapy in breast cancer?
b) What is the correlation of these changes to the treatment efficacy as determined by pathology?
- Secondary outcomec) How accurate can phospho-esters be determined with in vivo 7T MRS compared to ex vivo analysis?
d) How well do these values relate to the values obtained in preclinical studies?
- TimepointsPatients get a MRS scan prior to-, half way-, and after chemotherapy.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
- Publications1. Korteweg MA, Veldhuis WB, Visser F, Luijten PR, Mali WP, van Diest PJ, van den Bosch MA, Klomp DWJ. Feasibility of 7 Tesla Breast Magnetic Resonance Imaging Determination of Intrinsic Sensitivity and High-Resolution Magnetic Resonance Imaging, Diffusion-Weighted Imaging, and 1H-Magnetic Resonance Spectroscopy of Breast Cancer Patients Receiving Neoadjuvant Therapy. Invest Radiol. 2011 Jun;46(6):370-6.
2. Klomp DW, van de Bank BL, Raaijmakers A, Korteweg MA, Possanzini C, Boer VO, van de Berg CA, van de Bosch MA, Luijten PR. (31) P MRSI and (1) H MRS at 7 T: initial results in human breast cancer. NMR Biomed. 2011 Dec;24(10):1337-42
3. . Boer VO, Vd Bank BL, van Vliet G, Luijten PR, Klomp DW. Direct B(0) field monitoring and real-time B(0) field updating in the human breast at 7 tesla. Magn Reson Med. 2011 Dec 12. doi: 10.1002/mrm.23272. [Epub ahead of print]
4. van der Kemp WJ, Boer VO, Luijten PR, Wijnen JP, Klomp DW. Increase in SNR for (31) P MR spectroscopy by combining polarization transfer with a direct detection sequence. Magn Reson Med. 2011 Dec 12. doi: 10.1002/mrm.23260. [Epub ahead of print]
5. Wijnen JP, van der Kemp WJ, Luttje MP, Korteweg MA, Luijten PR, Klomp DW. Quantitative (31) P magnetic resonance spectroscopy of the human breast at 7 T. Magn Reson Med. 2011 Dec 28. doi: 10.1002/mrm.23249. [Epub ahead of print]
6. van de Bank BL, Voogt IJ, Italiaander M, Stehouwer BL, Boer VO, Luijten PR, Klomp DW. Ultra high spatial and temporal resolution breast imaging at 7T. NMR Biomed. 2012 Oct 18. doi: 10.1002/nbm.2868. [Epub ahead of print]
7. de Graaf RA, Klomp DW, Luijten PR, Boer VO. Intramolecular zero-quantum-coherence 2D NMR spectroscopy of lipids in the human breast at 7 T. Magn Reson Med. 2013 Mar 6. doi: 10.1002/mrm.24701. [Epub ahead of print]
8. van der Kemp WJ, Boer VO, Luijten PR, Stehouwer BL, Veldhuis WB, Klomp DW. Adiabatic multi-echo 31 P spectroscopic imaging (AMESING) at 7 T for the measurement of transverse relaxation times and regaining of sensitivity in tissues with short T2 * values. NMR Biomed. 2013 Apr 2 doi: 10.1002/nbm.2952. [Epub ahead of print]
9. Klomp DW, Dula AN, Arlinghaus LR, Italiaander M, Dortch RD, Zu Z, Williams JM, Gochberg DF, Luijten PR, Gore JC, Yankeelov TE, Smith SA. Amide proton transfer imaging of the human breast at 7T: development and reproducibility. NMR Biomed. 2013 Apr 4. doi: 10.1002/nbm.2947. [Epub ahead of print]
10.Stehouwer BL, Klomp DW, van den Bosch MA, Korteweg MA, Gilhuijs KG, Witkamp AJ, van Diest PJ, Houwert KA, van der Kemp WJ, Luijten PR, Mali WP, Veldhuis WB. Dynamic contrast-enhanced and ultra-high-resolution breast MRI at 7.0 Tesla. Eur Radiol. 2013 Nov;23(11):2961-8. doi: 10.1007/s00330-013-2985-9. Epub 2013 Aug 28.
11. de Leeuw H, Stehouwer BL, Bakker CJ, Klomp DW, van Diest PJ, Luijten PR, Seevinck PR, van den Bosch MA, Viergever MA, Veldhuis WB. Detecting breast microcalcifications with high-field MRI. NMR Biomed. 2014 Feb 17. doi: 10.1002/nbm.3089
12. 31P magnetic resonance spectroscopy of the breast and the influence of the menstrual cycle. Stehouwer BL, van der Kemp WJ, Luijten PR, van den Bosch MA, Veldhuis WB, Wijnen JP, Klomp DW.Breast Cancer Res Treat. 2014 Feb 26.
13. Boer VO, Luttje MP, Luijten PR, Klomp DW. Requirements for static and dynamic higher order B0 shimming of the human breast at 7 T. NMR Biomed. 2014 Feb 25. doi: 10.1002/nbm.3096
14. Korteweg MA, Veldhuis WB, Mali WP, Diepstraten SC, Luijten PR, van den Bosch MA, Eijkemans RM, van Diest PJ, Klomp DW. Investigation of lipid composition of dissected sentinel lymph nodes of breast cancer patients by 7T proton MR spectroscopy. J Magn Reson Imaging. 2011 Oct 3. doi: 10.1002/jmri.22820. [Epub ahead of print]
15. Stehouwer BL, Klomp DW, Korteweg MA, Verkooijen HM, Luijten PR, Mali WP, van den Bosch MA, Veldhuis WB. 7T versus 3T contrast-enhanced breast Magnetic Resonance Imaging of invasive ductulolobular carcinoma: First clinical experience. Magn Reson Imaging. 2012 Oct 30. doi:pii: S0730-725X(12)00359-1. 10.1016/j.mri.2012.09.005. [Epub ahead of print]
- Brief summary
- Main changes (audit trail)
- RECORD19-jun-2014 - 27-jul-2014

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