Nano MRI on 7 Tesla in Rectal and Breast Cancer

NCT ID: NCT02751606

Last Updated: 2018-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-11-30

Brief 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.

Detailed 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.

Conditions

Rectal Neoplasms; Breast Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Breast and rectal cancer

Subjects will receive intravenous dose of ferumoxtran-10. 24-36 hours later a 7 Tesla MRI scan will be performed, to detect lymph node metastases. In rectal cancer patients the mesorectum will be imaged and for breast cancer patients this will be performed in the ipsilateral axilla. Subjects will also undergo a 3 Tesla MRI scan as a comparison to the 7 Tesla MRI scan.

Group Type: EXPERIMENTAL

ferumoxtran-10

Intervention Type: DRUG

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

7 Tesla MRI

Intervention Type: DEVICE

Subjects undergo a 7 Tesla MRI scan

3 Tesla MRI

Intervention Type: DEVICE

Subjects undergo a 3 Tesla MRI scan

Interventions

ferumoxtran-10

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

Intervention Type: DRUG

7 Tesla MRI

Subjects undergo a 7 Tesla MRI scan

Intervention Type: DEVICE

3 Tesla MRI

Subjects undergo a 3 Tesla MRI scan

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

General criteria:

• Age > 18 years

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

• 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

• 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;

• Inflammatory diseases of the abdomen (such as Crohn's disease)
• Previous abdominal surgery or radiotherapy

• Prior radiotherapy or surgery to axillae

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom Scheenen, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboudumc Nijmegen

Locations

Radboud University Medical Centre

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Bart Philips, MD

Role: CONTACT

Bart.Philips@radboudumc.nl

+31 24 36 68392

Facility Contacts

Bart Philips, MD

Role: primary

bartphilips1@gmail.com

0631961348

Other Identifiers

7TNANO1

Identifier Type: -

Identifier Source: org_study_id