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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002935-27 | EudraCT Number |
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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
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The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI and gadofosveset-enhanced MRI for the management of rectal cancer patients.
Rectal cancer is a common form of cancer, and the treatment stratification depends on tumour and nodal stage as determined on MRI. Unfortunately, the information provided by standard T2-weighted MRI is not sufficient to accurately assess nodal involvement and tumour response after neo-adjuvant chemoradiotherapy. Additional functional information is required for reliable (re)staging. Diffusion-weighted imaging and gadofosveset-enhanced MRI are two new imaging techniques that have all shown great potential in rectal cancer staging. In order to provide definite evidence there is a need for a multicenter study with a large patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary staging group I | All patients will be treated according to standard practice of the concerning hospital. Patients in group I are patients that will be stratified for direct surgery (TME) or a short-course of radiotherapy (5x5 Gy) followed by immediate TME. Group I will undergo only a staging MRI, including gadofosveset-enhanced MRI. |
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| Restaging group II | All patients will be treated according to standard practice of the concerning hospital. Patients in group II are patients that will be stratified for a long course of chemoradiotherapy. Group II will undergo a staging MRI, a re-staging MRI and a optional sigmoidoscopy as part of restaging. MRI includes diffusion-weighted imaging and gadofosveset-enhanced MRI. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar] | Drug | Gadofosveset will be used as a lymph-node specific MRI contrast agent and will be administered by manual injection as a single intravenous bolus during MRI. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of the techniques under investigation | Techniques under investigation are diffusion-weighted imaging for tumour response assessment and gadofosveset-enhanced MRI for nodal assessment, compared to standard T2-weighted MRI. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the inter-observer agreement for the imaging techniques under investigation | Detection of the differences between expert vs non-expert readers and general vs referral centres concerning diffusion-weighted imaging and gadofosveset-enhanced MRI. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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All patients diagnosed with rectal cancer in one of the participating centres will be considered for inclusion in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Regina Beets-Tan, Prof. MD. | Radiology, MUMC | Principal Investigator |
| Geerard Beets, Ass Prof. MD | Surgery, MUMC | Principal Investigator |
| Doenja Lambregts, MD | Radiology, MUMC | Study Chair |
| Monique Maas, MD | Radiology, MUMC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Medisch Centrum | Heerlen | Limburg | 6401 CX | Netherlands | ||
| Maastricht University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16152740 | Background | Lahaye MJ, Engelen SM, Nelemans PJ, Beets GL, van de Velde CJ, van Engelshoven JM, Beets-Tan RG. Imaging for predicting the risk factors--the circumferential resection margin and nodal disease--of local recurrence in rectal cancer: a meta-analysis. Semin Ultrasound CT MR. 2005 Aug;26(4):259-68. doi: 10.1053/j.sult.2005.04.005. | |
| 22067400 |
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|
| Maastricht |
| Limburg |
| 6202 AZ |
| Netherlands |
| Orbis Medisch Centrum | Sittard-Geleen | Limburg | 6130 MB | Netherlands |
| Viecuri Medisch Centrum | Venlo | Limburg | 5912 BL | Netherlands |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | North Brabant | 5223 GZ | Netherlands |
| Amphia Ziekenhuis | Breda | North Brabant | 4800 RL | Netherlands |
| Catharina Ziekenhuis | Eindhoven | North Brabant | 5623 EJ | Netherlands |
| Maxima Medisch Centrum | Veldhoven | North Brabant | 5500 MB | Netherlands |
| AMC | Amsterdam | North Holland | 1100 DD | Netherlands |
| ZGT | Almelo | Overrijsel | 7600 SZ | Netherlands |
| Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewe KW, Buijsen J, Beets GL. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011 Dec 10;29(35):4633-40. doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7. |
| 20692872 | Background | Maas M, Nelemans PJ, Valentini V, Das P, Rodel C, Kuo LJ, Calvo FA, Garcia-Aguilar J, Glynne-Jones R, Haustermans K, Mohiuddin M, Pucciarelli S, Small W Jr, Suarez J, Theodoropoulos G, Biondo S, Beets-Tan RG, Beets GL. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol. 2010 Sep;11(9):835-44. doi: 10.1016/S1470-2045(10)70172-8. Epub 2010 Aug 6. |
| 17175450 | Background | Habr-Gama A, Perez RO, Proscurshim I, Campos FG, Nadalin W, Kiss D, Gama-Rodrigues J. Patterns of failure and survival for nonoperative treatment of stage c0 distal rectal cancer following neoadjuvant chemoradiation therapy. J Gastrointest Surg. 2006 Dec;10(10):1319-28; discussion 1328-9. doi: 10.1016/j.gassur.2006.09.005. |
| 21239980 | Background | Lambregts DM, Beets GL, Maas M, Kessels AG, Bakers FC, Cappendijk VC, Engelen SM, Lahaye MJ, de Bruine AP, Lammering G, Leiner T, Verwoerd JL, Wildberger JE, Beets-Tan RG. Accuracy of gadofosveset-enhanced MRI for nodal staging and restaging in rectal cancer. Ann Surg. 2011 Mar;253(3):539-45. doi: 10.1097/SLA.0b013e31820b01f1. |
| 12438057 | Background | Herborn CU, Lauenstein TC, Vogt FM, Lauffer RB, Debatin JF, Ruehm SG. Interstitial MR lymphography with MS-325: characterization of normal and tumor-invaded lymph nodes in a rabbit model. AJR Am J Roentgenol. 2002 Dec;179(6):1567-72. doi: 10.2214/ajr.179.6.1791567. |
| 21264658 | Background | Yamashita T, Takahara T, Kwee TC, Kawada S, Horie T, Inomoto C, Hashida K, Yamamuro H, Myojin K, Luijten PR, Imai Y. Diffusion magnetic resonance imaging with gadofosveset trisodium as a negative contrast agent for lymph node metastases assessment. Jpn J Radiol. 2011 Jan;29(1):25-32. doi: 10.1007/s11604-010-0513-2. Epub 2011 Jan 26. |
| 20978768 | Background | Kim SH, Lee JY, Lee JM, Han JK, Choi BI. Apparent diffusion coefficient for evaluating tumour response to neoadjuvant chemoradiation therapy for locally advanced rectal cancer. Eur Radiol. 2011 May;21(5):987-95. doi: 10.1007/s00330-010-1989-y. Epub 2010 Oct 27. |
| 19789256 | Background | Kim SH, Lee JM, Hong SH, Kim GH, Lee JY, Han JK, Choi BI. Locally advanced rectal cancer: added value of diffusion-weighted MR imaging in the evaluation of tumor response to neoadjuvant chemo- and radiation therapy. Radiology. 2009 Oct;253(1):116-25. doi: 10.1148/radiol.2532090027. |
| 21347783 | Background | Lambregts DM, Vandecaveye V, Barbaro B, Bakers FC, Lambrecht M, Maas M, Haustermans K, Valentini V, Beets GL, Beets-Tan RG. Diffusion-weighted MRI for selection of complete responders after chemoradiation for locally advanced rectal cancer: a multicenter study. Ann Surg Oncol. 2011 Aug;18(8):2224-31. doi: 10.1245/s10434-011-1607-5. Epub 2011 Feb 23. |
| 21673229 | Background | Curvo-Semedo L, Lambregts DM, Maas M, Thywissen T, Mehsen RT, Lammering G, Beets GL, Caseiro-Alves F, Beets-Tan RG. Rectal cancer: assessment of complete response to preoperative combined radiation therapy with chemotherapy--conventional MR volumetry versus diffusion-weighted MR imaging. Radiology. 2011 Sep;260(3):734-43. doi: 10.1148/radiol.11102467. Epub 2011 Jun 14. |
| 21178866 | Background | Habr-Gama A, Perez RO, Wynn G, Marks J, Kessler H, Gama-Rodrigues J. Complete clinical response after neoadjuvant chemoradiation therapy for distal rectal cancer: characterization of clinical and endoscopic findings for standardization. Dis Colon Rectum. 2010 Dec;53(12):1692-8. doi: 10.1007/DCR.0b013e3181f42b89. |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C109932 | gadofosveset trisodium |
| D007275 | Injections, Intravenous |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007267 | Injections |
| D004364 | Pharmaceutical Preparations |
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