Pilot study for multiparametric characterization and evaluation of the movement of upper abdominal organs by 4D MRI

Not Applicable

• Conditions: Primary hepatocellular carcinoma1-2 liver metastases; C25; C22.0; C78.7; Malignant neoplasm of pancreas; Liver cell carcinoma; Secondary malignant neoplasm of liver and intrahepatic bile duct

• Registration Number: DRKS00010966
• Lead Sponsor: niversitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie

Brief Summary

The respiratory-related pancreatic movement could be reduced by an average of 47 % - 51 % in the inferior-superior direction by using the corset. Movement in the anterior-posterior and left-right directions was not significantly affected. In most patients (>75%), no discomfort was reported with the use of the corset.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-07
• Study Completion: 2021-06-01
• Results First Posted: 2022-11-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

primary resectable or non-resectable adenocarcinoma of the pancreas without distant metastases (M0), with indication for (chemotherapy and following) surgical intervention
- primary hepatocellular carcinoma with indication for primary radiotherapy
- 1-2 liver metastases of a solid tumor with indication for radiotherapy
- Good general condition (ECOG performance status 0 or 1)
- written informed consent

Exclusion Criteria

- neoadjuvant (radio) chemotherapy
- multiple intra-abdominal surgical interventions, which affect the organ movability
- Lack of consent of the patient to participate in the study or lack of cooperation with regard to the therapy or follow-up
- Contraindication to performing an MRI scan (for example, pacemakers, cochlear implants, garnet or other metal fragments, hip replacement, insulin pump, spiral (intrauterine pessary), not removable piercings, tattoos or permanent make-up)
- Contraindication for administration of gadolinium contrast agents
- intense claustrophobia

Study & Design

• Study Type: interventional
• Study Design: Not specified