Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer
NCT ID: NCT01721785
Last Updated: 2017-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
307 participants
OBSERVATIONAL
2012-10-31
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]
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.
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.
GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]
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.
Interventions
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GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Written informed consent
Exclusion Criteria
* Pregnancy
* Locally recurrent rectal cancer
* A history of severe allergy to contrast agents
* Ineligibility to receive gadofosveset contrast (history of contrast allergy, impaired kidney function with a Glomerular Filtration Rate \<30 ml/min/1.73m2
* Incurable disease due to metastases or co-morbidity
18 Years
ALL
No
Sponsors
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Dutch Cancer Society
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Regina Beets-Tan, Prof. MD.
Role: PRINCIPAL_INVESTIGATOR
Radiology, MUMC
Geerard Beets, Ass Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Surgery, MUMC
Doenja Lambregts, MD
Role: STUDY_CHAIR
Radiology, MUMC
Monique Maas, MD
Role: STUDY_CHAIR
Radiology, MUMC
Locations
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Atrium Medisch Centrum
Heerlen, Limburg, Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Orbis Medisch Centrum
Sittard-Geleen, Limburg, Netherlands
Viecuri Medisch Centrum
Venlo, Limburg, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands
Amphia Ziekenhuis
Breda, North Brabant, Netherlands
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Maxima Medisch Centrum
Veldhoven, North Brabant, Netherlands
AMC
Amsterdam, North Holland, Netherlands
ZGT
Almelo, Overrijsel, Netherlands
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2012-002935-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12-2-051
Identifier Type: -
Identifier Source: org_study_id
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