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Development of an MRI scanning protocol for functional imaging of esophageal cancer.


- candidate number14316
- NTR NumberNTR3852
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-feb-2013
- Secondary IDs12/537 / NL42338.041.12; METC UMC Utrecht / CCMO Toetsingonline
- Public TitleDevelopment of an MRI scanning protocol for functional imaging of esophageal cancer.
- Scientific TitleDevelopment of an MRI scanning protocol for functional imaging of esophageal cancer.
- ACRONYM
- hypothesisA robust and geometrically correct MRI protocol can be developed that enables functional MR imaging before, during and after chemoradiation of esophageal cancer.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer
- Inclusion criteria1. Patients with pathologically proven esophageal cancer referred to the department of Radiotherapy for radiotherapy;
2. >18 years;
3. Written informed consent.
- Exclusion criteria1. Glomerular Filtration Rate (GFR) of <45 mL/min/1.73m2, unless the patient has risk factors for contrast nefropathy according to the UMCU protocol ‘Preventie contrastreactie en contrast nefropathie, Versie 2 februari 2012’. In patients with risk factors a GFR of 60 mL/min/1.73m2 will be required;
2. Known Gadovist allergy;
3. Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the UMC Utrecht.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-feb-2013
- planned closingdate30-jul-2013
- Target number of participants30
- InterventionsNone (patients undergo an MRI scan with contrast agent).
- Primary outcomeQuality of the MRI images as defined by robustness (i.e. that the protocol can successfully be applied in various patients) and geometrical accuracy. Those parameters are derived using image analysis. MR images are obtained before, during and/or after chemoradiotherapy.
- Secondary outcomeN/A
- TimepointsBefore, during and after radiotherapy.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Ir. A.L.H.M.W. Lier, van
- CONTACT for SCIENTIFIC QUERIESDr. Ir. A.L.H.M.W. Lier, van
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryThis study is aimed at optimizing a MR sequences for esophageal cancer imaging before, during and after chemoradiation. We will focus on diffusion-weighted imaging and dynamic contrast enhanced imaging. The obtained protocol will be used in future to verify if MRI can be used for treatment response monitoring of neo-adjuvant radiotherapy.
- Main changes (audit trail)
- RECORD4-feb-2013 - 25-feb-2013


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