Nano MRI on 7 Tesla in Rectal and Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Nano MRI on 7 Tesla: a Technical Validation Study in Rectal and Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02751606
• Other study ID #: 7TNANO1
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: November 2019

Study information

• Verified date: September 2017
• Source: Radboud University
• Contact: Bart Philips, MD
• Phone: +31 24 36 68392
• Email: Bart.Philips[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the diagnostic accuracy of an USPIO contrast agent (ferumoxtran-10) in combination with 7 Tesla MRI to detect lymph node metastases in rectal and breast cancer.

Description:

The Presence of lymph node metastases in cancer is a key factor for determining prognosis and forming an adequate treatment plan. Determining lymph node status, however, is a challenge. Ferumoxtran-10, an ultrasmall superparamagnetic iron oxide (USPIO) particle 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). For small lymph node metastases (<5mm) the diagnostic accuracy of this technique does, however, drop substantially. Most of the studies that have been performed with these particles used a 1.5 Tesla or 3 Tesla MRI scanner. The investigators would like to increase the resolution of nano-MRI by using a 7 Tesla scanner, such that the investigators can increase the sensitivity of this technique for small lymph nodes. With this study the investigators would like to validate the results of this technique with pathology in rectal and breast cancer. In these cancer types many patients undergo a surgical lymph node dissection by bulk excision of tissue including the nodes, enabling a node-to-node comparison between MRI and pathology to validate our nano-MRI results . If successful this technique would form a non-invasive alternative to the current lymph node staging techniques such as surgery. Additionally (if metastatic nodes are present), it could complement image guided focal therapies on lymph node metastases such as radiotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

General criteria:

• Age > 18 years

Inclusion criteria rectal cancer patients:

• Patients with recently histologically proven rectal cancer, who are planned to undergo a total mesorectal excision without neo-adjuvant radiotherapy.

Inclusion criteria breast cancer patients:

• Patients with recently histologically proven breast cancer (Stage II), who are planned for surgery with sentinel node procedure, but will receive no neo-adjuvant therapy or will undergo an axillary lymph node dissection without prior sentinel node procedure and will receive no neo-adjuvant therapy.

Exclusion Criteria:

General exclusion criteria:

• BMI > 30 kg/m2

• Pregnancy

• Karnofsky score <= 70

• Contraindications for 7T MRI:

• Epilepsy

• Inability to provide informed consent

• Metal implants that are not compatible with 7 Tesla MRI

• Contraindications to USPIO based contrast agents:

• prior allergic reaction to ferumoxtran-10 or any other iron preparation

• prior allergic reaction contributed to dextran or other polysaccharide, in any preparation

• prior allergic reaction to contrast media of any type

• hereditary hemochromatosis, thalassemia, sickle cell anemia;

Exclusion criteria for rectal cancer:

• Inflammatory diseases of the abdomen (such as Crohn's disease)

• Previous abdominal surgery or radiotherapy

Exclusion criteria for breast cancer:

• Prior radiotherapy or surgery to axillae

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms
• Rectal Neoplasms

Intervention

Drug:
• ferumoxtran-10
ferumoxtran-10 will be administered intravenously one day prior to the MRI scan

Device:
• 7 Tesla MRI
Subjects undergo a 7 Tesla MRI scan
• 3 Tesla MRI
Subjects undergo a 3 Tesla MRI scan

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Centre	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of 7 Tesla MRI in combination with ferumoxtran-10 on nodal level.	The images of the 7 Tesla MRI scan will be evaluated by a radiologist and every lymph node that is found will be scored as positive or negative. This will be compared to the pathological results to determine the sensitivity and specificity of ferumoxtran enhanced MRI on 7 Tesla for diagnosing whether a lymph node is metastatic or not.	within 2 weeks prior to the patients surgery
Secondary	Comparison of 7 Tesla and 3 Tesla MRI	The diagnostic accuracy (sensitivity and specificity as described in outcome 1) of 3 Tesla and 7 Tesla will be compared	within 2 weeks prior to the patients surgery