Response Assessment During MR-guided Radiation Therapy for Glioblastoma

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05565326

Studienbeginn:
September 2022

Letztes Update:
04.10.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Glioblastoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Zurich

Collaborator:
-

Kontakt

Michael Mayinger, MD
Kontakt:
Phone: +41432530691
E-Mail: michael.mayinger@usz.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Zurich
8091 Zürich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Michael Mayinger, MD
Phone: +410432530691» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

The study seeks to assess the response of glioblastoma multiforme to treatment using weekly

low field (0.35 T) MR-images of the brain at a MRIdian® linac system during standard

radiotherapy at the same system. A total of 20 patients in a single arm will be recruited for

this investigation.

The imaging data will be used to evaluate the change in tumor volume over the course of the

treatment and to perform radiomics in order to investigate the possibility of response

prediction using these images.

In order to assure sufficient image quality, prior to the main investigation, a group of up

to 20 volunteers has MR scans taken with identical sequences to the main study phase.

Ein-/Ausschlusskriterien

Inclusion criteria patients:

Subjects fulfilling all of the following criteria are eligible for the study:

- Informed Consent as documented by signature according to Swiss law and ICH/GCP

regulations before any trial specific procedures (Appendix I Informed Consent Form)

- Histologically confirmed diagnosis of GBM

- Indication for fractionated radiation therapy for GBM

- Age: ≥ 18 years old

- Gender: any

- Karnofsky performance status ≥60

- Patients who are willing and able to comply with scheduled visits, treatment, and

other trial procedures

Exclusion criteria

- The presence of any one of the following criteria will lead to exclusion of the

subject:

- Previous cranial radiation therapy

- Contraindications to MR examinations, e.g., non-compatible implantable device or

metallic foreign bodies

- Inability to complete MR examination due to claustrophobic anxiety

- Women who are pregnant or breast feeding,

- Intention to become pregnant during the course of the study

- Lack of safe contraception, defined as: Female subjects of childbearing potential, not

using and not willing to continue using a medically reliable method of contraception

for the entire study duration, such as oral, injectable, or implantable

contraceptives, or intrauterine contraceptive devices, or who are not using any other

method considered sufficiently reliable by the investigator in individual cases.

Female subjects who are surgically sterilized / hysterectomized or post-menopausal for

longer than 2 years are not considered as being of child bearing potential.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active

infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris,

or cardiac arrhythmia

- Known or suspected non-compliance, drug or alcohol abuse

- Inability to follow the procedures of the study, e.g. due to language problems,

psychological disorders, dementia, etc. of the subject

- Participation in another study with investigational drug within the 30 days preceding

and during the present study

- Enrolment of the investigator, his/her family members, employees and other dependent

persons

Studien-Rationale

Primary outcome:

1. To assess target volume changes with MRI during fractionated MR-guided radiation therapy. (Time Frame - 6 Months)

Secondary outcome:

1. Value of target changes with MRI during fractionated MR-guided radiation therapy (Time Frame - 6 Months)

Geprüfte Regime

Low field (0.35 T) MR-images of the brain at a MRIdian® linac system:
Low field (0.35 T) MR-images of the brain at a MRIdian® linac system using CE marked low-field MR coils as provided by the company will be taken for volunteers in phase I. In phase II and III, after therapy beginning those images will be taken once per week per subject using CE marked low-field MR coils as provided by the company. This is done over the entire course of radiotherapy, which takes between 3 and 6 weeks.

Quelle: ClinicalTrials.gov

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