The primary objectives are to determine the diagnostic performance of gadofosveset-enhanced T1-weighted MR imaging for the discrimination between pN0 and pN+ patients for both primary staging and restaging after chemoradiotherapy and to determine…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the diagnostic performance of the techniques under
investigation (gadofosveset-enhanced MRI for nodal assessment and DWI for the
tumour response assessment after chemoradiotherapy).
Secondary outcome
n.a.
Background summary
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 with 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.
Study objective
The primary objectives are to determine the diagnostic performance of
gadofosveset-enhanced T1-weighted MR imaging for the discrimination between pN0
and pN+ patients for both primary staging and restaging after chemoradiotherapy
and to determine the diagnostic value of DWI for the assessment of response
after chemoradiotherapy, compared to standard T2-weighted MR imaging. The
secondary objectives are to determine the inter-observer agreement for the
imaging techniques under investigation (gadofosveset-enhanced MRI and DWI for
the tumour response assessment after chemoradiotherapy) and the differences
between expert vs. non-expert readers and general vs. referral centres. Also to
compare the over- and understaging rates for all the techniques under
investigation with the conventional imaging.
Study design
Multicenter prospective observational cohort study
Study burden and risks
There is a relatively low rate of side effects associated with gadofosveset.
Results of this study will help to establish a non-invasive diagnostic tool for
the accurate prediction of nodal status, and accurate response evaluation after
neo-adjuvant chemoradiotherapy in rectal cancer patients. Therefore, the
benefit-risk ratio for this study is regarded as favourable.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Biopsy proven primary rectal cancer (*15 cm from the anorectal verge as measured on 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-002935-27-NL |
| CCMO | NL41208.068.12 |