Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer

Condition(s) targeted: Rectal Neoplasms; Magnetic Resonance Imaging; Neoplasms Staging

Intervention: Gadofosveset trisodium (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Maastricht University Medical Center

Official(s) and/or principal investigator(s):
Regina Beets-Tan, Prof. MD., Principal Investigator, Affiliation: Radiology, MUMC
Geerard Beets, Ass Prof. MD, Principal Investigator, Affiliation: Surgery, MUMC
Doenja Lambregts, MD, Study Chair, Affiliation: Radiology, MUMC
Monique Maas, MD, Study Chair, Affiliation: Radiology, MUMC

Overall contact:
Luc Heijnen, MD, Phone: (+31)(0)43 3882938, Email: crc.research@mumc.nl

This 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.

Official title: Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Diagnostic performance of the techniques under investigation

Secondary outcome: To determine the inter-observer agreement for the imaging techniques under investigation

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Biopsy proven primary rectal cancer (≤15 cm from the anorectal verge as measured in

MRI)

- Age > 18 years

- Written informed consent

Exclusion Criteria:

- Ineligibility to undergo MRI (claustrophobia, pacemaker, non-MR compatible surgical

implants, metal fragments in the eye)

- 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

Luc Heijnen, MD, Phone: (+31)(0)43 3882938, Email: crc.research@mumc.nl

Canisius-Wilhelmina Ziekenhuis, Nijmegen, Gelderland 6500 GS, Netherlands; Not yet recruiting
F Kemper, MD, Phone: (+31)(0)24-3657466, Email: fjm.kemper@gmail.com
F Polat, MD, Phone: (+31)(0)24-3658721, Email: f.polat@cwz.nl
F Kemper, MD, Principal Investigator
F Polat, MD, Sub-Investigator

Atrium Medisch Centrum, Heerlen, Limburg 6401 CX, Netherlands; Not yet recruiting
R Vliegen, MD. PhD., Phone: (+31)(0)45-5766642, Email: rvn05@atriummc.nl
E Belgers, MD., Phone: (+31)(0)45-5766599, Email: e_belga@hotmail.com
R Vliegen, MD. PhD., Principal Investigator
E. Belgers, MD., Sub-Investigator

Maastricht University Medical Center, Maastricht, Limburg 6202 AZ, Netherlands; Recruiting
Luc Heijnen, MD, Phone: 0031433882938, Email: crc.research@mumc.nl
Regina Beets-Tan, MD, PhD, Principal Investigator
Geerard Beets, MD, PhD, Principal Investigator

Orbis Medisch Centrum, Sittard-Geleen, Limburg 6130 MB, Netherlands; Not yet recruiting
M Osinga-de Jong, MD., Phone: (+31)(0)88-4595450, Email: m.osinga@orbisconcern.nl
E Belgers, MD., Phone: (+31)(0)45-5766599, Email: e_belga@hotmail.com
M Osinga-de Jong, MD, Principal Investigator
E Belgers, MD, Sub-Investigator

Viecuri Medisch Centrum, Venlo, Limburg 5912 BL, Netherlands; Not yet recruiting
M Bilderbeek, MD, Phone: (+31)(0)77-3205555, Email: mbilderbeek@viecuri.nl
C van Berlo, MD PhD, Phone: (+31)(0)77-3205309, Email: vcberlo@viecuri.nl
M Bilderbeek, MD, Principal Investigator
P Post, MD, Sub-Investigator
C van Berlo, MD PhD, Sub-Investigator

Catharina Ziekenhuis, Eindhoven, Noord-Brabant 5623 EJ, Netherlands; Not yet recruiting
A Daniels, MD PhD, Phone: (+31)(0)40-2399111, Email: alettedg@gmail.com
H Rutten, MD PhD, Phone: (+31)(0)40-2399111, Email: harm.rutten@catharina-ziekenhuis.nl
A Daniels, MD PhD, Principal Investigator
H Rutten, MD PhD, Sub-Investigator

Maxima Medisch Centrum, Veldhoven, Noord-Brabant 5500 MB, Netherlands; Not yet recruiting
G Slooter, MD. PhD., Phone: (+31)(0)40-8888550, Email: g.slooter@mmc.nl
F van de Wiel, MD, Phone: (+31)(0)40-8889000, Email: f.vandewiel@mmc.nl
G Slooter, MD PhD, Principal Investigator
F van de Wiel, MD, Sub-Investigator

Related publications:

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.

Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewé 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. Epub 2011 Nov 7. PubMed PMID: 22067400.

Maas M, Nelemans PJ, Valentini V, Das P, Rödel C, Kuo LJ, Calvo FA, García-Aguilar J, Glynne-Jones R, Haustermans K, Mohiuddin M, Pucciarelli S, Small W Jr, Suárez 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. 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.

Lambregts DM, Beets GL, Maas M, Kessels AG, Bakers FC, Cappendijk VC, Engelen SM, Lahaye MJ, de Bruïne 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.

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.

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. 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. 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.

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. 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. 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.

Starting date: October 2012
Last updated: November 2, 2012