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Clinical target volumes in breast-conserving therapy.


- candidate number10705
- NTR NumberNTR3198
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-dec-2011
- Secondary IDsNL3704504111 CCMO
- Public TitleClinical target volumes in breast-conserving therapy.
- Scientific TitleComparison of pre- and postoperative clinical target volumes at CT and MRI imaging in breast-conserving therapy: A prospective cohort study.
- ACRONYM
- hypothesisPre-operative target volume delineation instead of post-operative delineation and the use of MRI instead of CT, would lead to improved target volume delineation.
- Healt Condition(s) or Problem(s) studiedRadiotherapy, Target volume delineation
- Inclusion criteria1. Female gender;
2. Age 18 years, 70 years;
3. cTis-T2N0Mx breast cancer;
4. Scheduled for breast-conserving therapy;
5. Before breast-conserving surgery;
6. Written informed consent.
- Exclusion criteria1. Legal incapability;
2. Insufficient command of the Dutch language;
3. History of ipsilateral breast surgery (benign, malign, augmentation, reduction);
4. Inability to maintain the standard supine RT treatment position for 30 minutes;
5. Exclusion criteria for MRI following the protocol of the department of radiology UMCU;
6. Severe renal failure of creatinine clearance of <50mL/min/1.73m2;
7. Idodine allergy (contraindication for iodine-based intravenous contrast agents);
8. Treated with neo-adjuvant chemotherapy;
9. Treated with modified radical mastectomy;
10. Treated with axillary lymph node dissection.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 17-nov-2011
- planned closingdate17-nov-2012
- Target number of participants20
- Interventions1. Pre-operative CE-CT+CE-MRI;
2. Post-operative CE-CT+CE-MRI. (x2).
- Primary outcomeClinical target volumes pre-BCS and post-BCS on both CT and MR imaging.
- Secondary outcomeN/A
- Timepoints1. Pre-operative;
2. Post-operative (2x)
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. M.D. Hartogh, den
- CONTACT for SCIENTIFIC QUERIESDrs. M.D. Hartogh, den
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryStandard breast-conserving therapy consists of breast-conserving surgery (BCS) followed by radiotherapy. Previous planning studies on pre-operative imaging and target volume delineation have observed a theoretical reduction in irradiated volumes and a reduction in radiation dose in organs at risk, compared to post-operative imaging. Smaller irradiated volumes might result in decreased toxicity and improved cosmetic outcome. Furthermore, due to improved soft tissue contrast, studies have shown the possible advantages of MR imaging instead of CT imaging in the post-operative setting. In this study we will compare both pre- vs. post-operative target volume delineation, and CT vs. MR imaging.
- Main changes (audit trail)
- RECORD16-dec-2011 - 26-mrt-2014


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