To validate the use of 3 and 7 Tesla nano-MRI in restaging locally advanced rectal cancer by node-to-node matching of the results of nano-MRI with pathology as the gold standard.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity and specificity of 3T and 7T MRI scans with ferumoxtran-10
enhancement for lymph node metastasis detection after chemoradiotherapy in
locally advanced rectal cancer patients. We will make a subdivision into small
(<5mm) and large nodes (*5mm).
Secondary outcome
Comparing the sensitivity and specificity of 3T and 7T
Background summary
Locally advanced rectal cancer is treated by neoadjuvant chemoradiotherapy
followed by a total mesorectal excision. Total mesorectal excision (TME) is
associated with a large impact on quality of life and patients might end up
with a permanent colostoma. The decision towards surgical treatment is made on
the basis of a restaging MRI after chemotherapy. Because of the impact on the
quality of life of a TME, the current paradigm is shifting towards organ
preserving treatments. One of the key factors in determining an adequate
treatment plan is knowing how much the disease has progressed into the regional
lymph nodes. Determining this lymph node status however, is a challenge, and
the current techniques used in the restaging MRI have a sensitivity of
approximately 60% for detecting these lymph nodes.
One of the methods to improve upon this sensitivity is the use of lymph node
specific contrast agents, such as Ferumoxtran-10: an ultrasmall
superparamagnetic iron oxide (USPIO) particle that has proven to be a valuable
contrast agent for detecting lymph node metastases using magnetic resonance
imaging (MRI) in various types of cancer (also called nano-MRI). We would like
to perform a node to node validation of nano-MRI in rectal cancer after
neoadjuvant chemoradiotherapy, to evaluate its performance at the time of a
restaging MRI. With this, we can improve the sensitivity for detection of small
lymph node metastases when restaging rectal cancer. As affected lymph nodes in
the mesorectum can be really small, the nano-MRI scan is also performed on a 7
Tesla MRI scanner for the highest possible sensitivityto detect small lymph
node metastases. Nano-MRI results will be validated with pathology. The total
mesorectal excision, which includes the mesorectal lymph nodes enables an
accurate node-to-node comparison between MRI and pathology to validate our
nano-MRI results.
Study objective
To validate the use of 3 and 7 Tesla nano-MRI in restaging locally advanced
rectal cancer by node-to-node matching of the results of nano-MRI with
pathology as the gold standard.
Study design
Observational study
Study burden and risks
Except for the discomfort of lying in two separate MRI scanners for about 1
hour, MRI offers no risks for patients without pre-assessed contra-indications
(e.g. metallic implants). The contrast agent ferumoxtran-10 can cause a
contrast reaction during and shortly after administration. Therefore this
administration is performed within the hospital under supervision of qualified
personnel.
Geert Grooteplein-Zuid 10
Nijmegen 6500 HB
NL
Geert Grooteplein-Zuid 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
General criteria:
- Age > 18 years;Specific Inclusion criteria:;- Patients with recently histologically proven rectal cancer, who are:;o Planned to undergo neoadjuvant radiotherapy 50.4 Gy with concomitant chemotherapy consisting of capecitabin 825-1000 mg/m2 and/or oxaliplatin 85 mg/m² .;and;o Planned to undergo a total mesorectal excision.
Exclusion criteria
General exclusion criteria:;- Abdominal circumference > 120cm
- Pregnancy;- Karnofsky score <= 70;- Contraindications for 3T MRI:
o Epilepsy
o Inability to provide informed consent
o Metal implants that are not compatible with 3 Tesla MRI;- Contraindications to USPIO based contrast agents:
o prior allergic reaction to ferumoxtran-10 or any other iron preparation
o prior allergic reaction contributed to dextran or other polysaccharide, in any preparation
o prior allergic reaction to contrast media of any type
o hereditary hemochromatosis, thalassemia, sickle cell anemia;;- Contraindications to bisacodyl or butylscopolamine:
o cardiac arrhythmia,
o myasthenia gravis,
o urinary retention,
o gastrointestinal stenoses,
o kidney failure
o glaucoma, ;- Inflammatory diseases of the abdomen (such as Crohn*s disease);- Previous oncological related abdominal and/or pelvic surgery or radiotherapy
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 | EUCTR2016-002588-32-NL |
| CCMO | NL58295.091.16 |