MRI to detect lymph node metastases using iron contrast and high field MRI in rectal cancer

Phase 1

Conditions: ymph node metastases in rectal cancer
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-002588-32-NL

Lead Sponsor: Radboudumc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

General criteria:
-Age > 18 years

Inclusion criteria rectal cancer patients:
-Patients with recently histologically proven rectal cancer, who are:
oPlanned to undergo neoadjuvant radiotherapy 50.4 Gy with concomitant chemotherapy consisting of capecitabin 825-1000 mg/m2 and/or oxaliplatin 85 mg/m² .
and
oPlanned to undergo a total mesorectal excision.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

General exclusion criteria:

-Abdominal circumference > 120cm
-Pregnancy

-Karnofsky score <= 70

-Contraindications for 3T MRI:
oEpilepsy
oInability to provide informed consent
oMetal implants that are not compatible with 3 Tesla MRI

-Contraindications to USPIO based contrast agents:
oprior allergic reaction to ferumoxtran-10 or any other iron preparation
oprior allergic reaction contributed to dextran or other polysaccharide, in any preparation
oprior allergic reaction to contrast media of any type
ohereditary hemochromatosis, thalassemia, sickle cell anemia;

-Contraindications to bisacodyl or butylscopolamine:
ocardiac arrhythmia,
omyasthenia gravis,
ourinary retention,
ogastrointestinal stenoses,
okidney failure
oglaucoma,

-Inflammatory diseases of the abdomen (such as Crohn’s disease)

-Previous abdominal surgery or radiotherapy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Validate the results of Nano MRI (use of MRI in combination with ferumoxtran) with actual pathology in rectal cancer;Secondary Objective: compare 7 tesla and 3 tesla MRI for lymph node detection in locally advanced rectal cancer;Primary end point(s): Sensitivity and specificity of 7T MRI scans with Sinerem enhancement for lymph node metastasis detection. We will make a subdivision into small (<5mm) and large nodes(=5mm).;Timepoint(s) of evaluation of this end point: 1-2 weeks before total mesorectal excision.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): comparison between 3T and 7T on sensitivity and specificity;Timepoint(s) of evaluation of this end point: 1-2 weeks before total mesorectal excision.