SPIO- enhanced High Field MRI for restaging lymph node status in rectal cancer: an explorative study

Completed

Conditions: lymph node metastases
10027476

Registration Number: NL-OMON45911

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

General criteria:
- Age > 18 years;Specific ;- 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity and specificity of 3T and 7T MRI scans with ferumoxtran-10<br /><br>enhancement for lymph node metastasis detection after chemoradiotherapy in<br /><br>locally advanced rectal cancer patients. We will make a subdivision into small<br /><br>(<5mm) and large nodes (*5mm).</p><br>

Secondary Outcome Measures