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MPAC-study: A feasibility study of the co-registration of MRI-imaging with PAthological assessment of primary tumor extension in patients with uterine Cervical tumors.


- candidate number14472
- NTR NumberNTR3886
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-mrt-2013
- Secondary IDs39945 CCMO
- Public TitleMPAC-study: A feasibility study of the co-registration of MRI-imaging with PAthological assessment of primary tumor extension in patients with uterine Cervical tumors.
- Scientific TitleMPAC-study: MRI and PA correlation in uterine Cervical cancer.
- ACRONYMMPAC
- hypothesisMRI is accurate in measuring uterine involvement in uterine cervical cancer.
- Healt Condition(s) or Problem(s) studiedMRI, Cervical cancer
- Inclusion criteriaAll patients with early uterine cervical cancer (FIGO stages < IIA) for whom a Wertheim Okabayashi procedure and a MRI is planned.
- Exclusion criteria1. MRI: claustrophobia, pacemaker, medicine pump, neurostimulator, cochlear implants, other metal implants in the pelvis that would disturb the image. In some cases surgical clips in the brain are contra-indicated, this will be evaluated conform standard protocol;
2. GFR < 30 ml/min/1,73 mē.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2013
- planned closingdate1-sep-2013
- Target number of participants10
- InterventionsMeasure uterine extension of uterine cervical cancer on MRI and compare with histopathology.
- Primary outcomeAccuracy of linear extension.
- Secondary outcomeAcccuracy of tumor volume.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Peter Boer, de
- CONTACT for SCIENTIFIC QUERIES Peter Boer, de
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryEarly recognition of involvement into the uterine internal os is crucial for treatment decision making; it provides a more reliable choice of fertility sparing surgery in young women with early-stage uterine cervical cancer (Plante 2008). Secondly for optimization of radiation treatment planning fields information on tumor extension is necessary in patients with locally advance uterine cervical cancer (FIGO stage IIB-IVA). (Green 2005, Eifel 2004, Tanderup 2010) Possible extension of cervical cancer into the uterine body is well known for decades (Fletcher 1973). However, this treatment with large radiation fields has various limitations. For example, late complications like radiation enteritis, proctitis, cystitis as well as fistulae and sexual dysfunction, are the main limiting factor for dose escalation (Bipat 2011, Follen 2003, Groenendaal 2010, Herneth 2003). Also, it is questionable whether the whole uterine body needs to be included in the clinical target volume (CTV), as recommended in international guidelines [Caldas-Magelhaes 2012, Hoogendam 2010, Jemal 2010, Kwee 2008, Kwee 2009). Although MRI is generally considered as a reliable method to assess involvement in surrounding tissues for uterine cervical cancer, it is not established how accurate MRI is for measuring tumor growth into the internal os (Peppercorn 1999, Mitchell 2006, Sahdev 2007, Mandfredi 2009). Therefore the purpose of this study is to validate the MRI for maesuring involvement of uterine cervical cancer into the internal os.
- Main changes (audit trail)
- RECORD7-mrt-2013 - 20-mrt-2013


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