Pre-operative target volume delineation instead of post-operative delineation and the use of MRI instead of CT, would lead to improved target volume delineation.
ID
Bron
Aandoening
Target volume delineation in radiotherapy.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Clinical target volumes pre-BCS and post-BCS on both CT and MR imaging.
Achtergrond van het onderzoek
Standard 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.
Doel van het onderzoek
Pre-operative target volume delineation instead of post-operative delineation and the use of MRI instead of CT, would lead to improved target volume delineation.
Onderzoeksopzet
1. Pre-operative;
2. Post-operative (2x)
Onderzoeksproduct en/of interventie
1. Pre-operative CE-CT+CE-MRI;
2. Post-operative CE-CT+CE-MRI. (x2).
Algemeen / deelnemers
Radiotherapie, HP Q00.118<br>
Postbus 85500
M.D. Hartogh, den
Utrecht 3508 GA
The Netherlands
+31 (0)88 7550474
M.denHartogh-3@umcutrecht.nl
Wetenschappers
Radiotherapie, HP Q00.118<br>
Postbus 85500
M.D. Hartogh, den
Utrecht 3508 GA
The Netherlands
+31 (0)88 7550474
M.denHartogh-3@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Female gender;
2. Age ¡Ý 18 years, ¡Ü 70 years;
3. cTis-T2N0Mx breast cancer;
4. Scheduled for breast-conserving therapy;
5. Before breast-conserving surgery;
6. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3050 |
| NTR-old | NTR3198 |
| CCMO | NL37045.041.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38406 |