Innovative MRI techniques to improve treatment stratification of patients with Esophageal cancer: an optimization and pilot study

Innovative MRI techniques to improve treatment stratification of patients with Esophageal cancer: an optimization and pilot study - IMPROVE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44292

Enrollment

Registered

2014-06-20

Start date

2015-04-28

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer esophageal tumor

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Volunteers: • Written informed consent.;Patients: • 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.

Exclusion criteria

Exclusion criteria: • 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) • Deminished kidney function (eGFR

Design outcomes

Primary

Measure	Time frame
For USPIO MRI the main endpoint is the change in T2 and T2* at the tumor and lymph nodes on MRI after the administration of USPIO. For DWI the main endpoint is the perfusion fraction f and the diffusion coefficient D obtained by IVIM of the primary tumor. For T2* MRI the main endpoint is T2* of the primary tumor. For DCE MRI the main endpoint is the 'transfer constant' Ktrans and 'rate constant' kep, of the (remaining) primairy tumor	—

Measure

Time frame

For USPIO MRI the main endpoint is the change in T2 and T2* at the tumor and lymph nodes on MRI after the administration of USPIO. For DWI the main endpoint is the perfusion fraction f and the diffusion coefficient D obtained by IVIM of the primary tumor. For T2* MRI the main endpoint is T2* of the primary tumor. For DCE MRI the main endpoint is the 'transfer constant' Ktrans and 'rate constant' kep, of the (remaining) primairy tumor

—

Secondary

Measure	Time frame
Correlation of the MRI findings with pathology	—

Countries

Netherlands

Outcome results