Innovative MRI Techniques to Improve Treatment Stratification of Patients With Esophageal Cancer

NCT02253602 | Completed

• 1 other identifier: NL48757.018.14
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The current standard treatment of resectable esophageal cancer consists of neoadjuvant chemoradiation followed by resection. However, some patients develop recurrent disease despite chemoradiation and additional (systemic) treatment might have been indicated. Other patients show a (nearly) complete response after chemoradiation and could possibly have been treated with a less extensive treatment regimen. In patients without a threatened circumferential resection margin (CRM) and lymph node metastases chemoradiotherapy could possibly be omitted. Better stratification of patients with esophageal cancer is therefore urgently needed. Functional magnetic resonance imaging techniques (MRI) can provide in vivo, quantitative information on tumor biology and may prove to be a useful non-invasive tool for this purpose. In this project, ultra-small superparamagnetic particles of iron oxide (USPIO) enhanced MRI using ferumoxytol (Rienso®), diffusion weighted MRI (DWI) and T2\* MRI will be developed, both in terms of improvement of acquisition and data processing techniques.

Conditions

Esophageal Neoplasms

Keywords

Esophageal Neoplasms; Lymph Nodes; USPIO; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (4)

• USPIO MRI

  For USPIO enhanced MRI the main endpoint is the change in T2 and T2\* at the tumor and lymph nodes on MRI after the administration of USPIO.

  24, 48 or 72 hours after USPIO administration

• DWI/IVIM MRI

  For DWI the main endpoint is the perfusion fraction f and the diffusion coefficient D obtained by IVIM of the primary tumor.

  1 hour before USPIO administration

• T2* MRI

  For T2\* MRI the main endpoint is T2\* of the primary tumor

  1 hour before USPIO administration

• Ferumoxytol dose response

  For Ferumoxytol dose evaluation the main endpoint is the change in T2 and T2\* at the tumor and lymph nodes on MRI at 24, 48, 72 hours and 12 weeks after the administration of Ferumoxytol.

  24, 48, 72 hours and 12 weeks after the administration of Ferumoxytol

Study Arms (3)

Ferumoxytol Dose optimization

EXPERIMENTAL

We will assess three different dose levels of Ferumoxytol (4 mg/kg, 6 mg/kg, 8 mg/kg). Images will be acquired at baseline (before Ferumoxytol administration), during injection of Ferumoxytol and 24, 48 and 72 hours after Ferumoxytol administration to identify the optimal moment of scanning.To assess whether USPIOs are sufficiently cleared within 12 weeks from lymph nodes, the MRI scans will be repeated in all six volunteers at 12 weeks after Ferumoxytol administration. Thus, volunteers will undergo an MRI scan for five times. Ferumoxytol is administered only once

Drug: Ferumoxytol

Before Surgery

EXPERIMENTAL

Twenty patients will be measured directly before surgery. Patients will be measured at baseline, during injection of Ferumoxytol and 24, 48 or 72 hours after Ferumoxytol administration, depending on the results of the dose optimization study. MR parameters will be correlated with pathology data.

Drug: Ferumoxytol

Before Neoadjucant therapy

EXPERIMENTAL

Ten patients will be measured before start of neoadjuvant chemoradiation. Patients will be measured at baseline, during injection of Ferumoxytol and 24, 48 or 72 hours after Ferumoxytol administration, based on the dose optimization study. MR parameters will be correlated with pathology data.

Drug: Ferumoxytol

Interventions

Ferumoxytol DRUG

maximum rate of administration 1 ml/sec

Also known as: USPIO, Rienso

Before Neoadjucant therapy; Before Surgery; Ferumoxytol Dose optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with biopsy proven esophageal cancer (squamous cell carcinoma or adenocarcinoma)
• Suspected nodal involvement on EUS or CT at diagnosis.
• WHO-performance score 0-2
• Scheduled for surgery
• Written informed consent

You may not qualify if:

• Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol
• Contra-indications for MR scanning, including patients with a pacemaker, cochlear implant or neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; or a non-MR compatible aneurysm clip in their brain; patients with severe claustrophobia
• Active inflammatory diseases
• History of anaphylaxis or other hypersensitivity reactions
• History of iron overload
• History of abnormal liver function, or elevated liver enzymes (ALAT, ASAT \> 3 times upper limit of normal)
• Elevated Serum Transferrin Saturation (TSAT) (\>50%) or hemoglobin (\>10.5mmol/L)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Ferrosoferric Oxide; ferumoxtran-10

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Hanneke WM van Laarhoven, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: October 1, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

NL (1)