NCT04172753

Brief Summary

This study investigates the feasibility of imaging and treatment on a novel 1.5 T MR-Linac radiotherapy hybrid device.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
472

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
May 2018May 2027

Study Start

First participant enrolled

May 9, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2027

Expected
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

4 years

First QC Date

November 4, 2019

Last Update Submit

November 19, 2019

Conditions

Rectal CancerHead and Neck CancerLiver CancerBreast CancerProstate CancerOligometastasisEsophageal Cancer

Keywords

RadiotherapyAdaptive Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Feasibility of online MR guided Radiotherapy

    Treatment of a patient is considered feasible when 85% of treatments were completed as planned in this patient

    During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)

Secondary Outcomes (1)

  • Time analysis

    During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)

Study Arms (9)

Rectal and anal cancer

EXPERIMENTAL

In this arm patients with rectal and anal cancer are recruited.

Radiation: Radiotherapy on the MR-Linac

Prostate cancer

EXPERIMENTAL

In this arm patients with prostate cancer are recruited.

Radiation: Radiotherapy on the MR-Linac

Head and neck cancer

EXPERIMENTAL

In this arm patients with head and neck cancers are recruited.

Radiation: Radiotherapy on the MR-Linac

Esophageal cancer

EXPERIMENTAL

In this arm patients with esophageal cancer are recruited.

Radiation: Radiotherapy on the MR-Linac

Breast Cancer

EXPERIMENTAL

In this arm patients with breast cancer are recruited.

Radiation: Radiotherapy on the MR-Linac

Central nervous system tutors

EXPERIMENTAL

In this arm patients with tumors of the central nervous system are recruited.

Radiation: Radiotherapy on the MR-Linac

Palliative treatments

EXPERIMENTAL

In this arm patients with palliative treatments are recruited.

Radiation: Radiotherapy on the MR-Linac

Other

EXPERIMENTAL

In this arm patients with other tumors are recruited.

Radiation: Radiotherapy on the MR-Linac

Imaging only

EXPERIMENTAL

In this arm patients receive only imaging on the MR-Linac

Diagnostic Test: Imaging on the MR Linac

Interventions

Radiotherapy on the MR-LinacRADIATION

Radiotherapy is performed on the 1.5 T MR Linac

Breast CancerCentral nervous system tutorsEsophageal cancerHead and neck cancerOtherPalliative treatmentsProstate cancerRectal and anal cancer
Imaging on the MR LinacDIAGNOSTIC_TEST

Only imaging performed on the MR Linac

Imaging only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • existing indication for radiation therapy
  • minimum age 18 years, no upper age limit
  • capacity for consent
  • Informed consent

You may not qualify if:

  • contraindication for MRI (claustrophobia, metallic implants not applicable for MRI
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tübingen, Department of Radiation Oncology

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Related Publications (2)

  • Boeke S, Habrich J, Kubler S, Boldt J, Schick F, Nikolaou K, Kubler J, Gani C, Niyazi M, Zips D, Thorwarth D. Longitudinal assessment of diffusion-weighted imaging during magnetic resonance-guided radiotherapy in head and neck cancer. Radiat Oncol. 2025 Jan 29;20(1):15. doi: 10.1186/s13014-025-02589-9.

    PMID: 39881423DERIVED

  • Potkrajcic V, Gani C, Fischer SG, Boeke S, Niyazi M, Thorwarth D, Voigt O, Schneider M, Monnich D, Kubler S, Boldt J, Hoffmann E, Paulsen F, Mueller AC, Wegener D. Online Adaptive MR-Guided Ultrahypofractionated Radiotherapy of Prostate Cancer on a 1.5 T MR-Linac: Clinical Experience and Prospective Evaluation. Curr Oncol. 2024 May 9;31(5):2679-2688. doi: 10.3390/curroncol31050203.

    PMID: 38785484DERIVED

MeSH Terms

Conditions

Rectal NeoplasmsHead and Neck NeoplasmsLiver NeoplasmsBreast NeoplasmsProstatic NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesLiver DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesEsophageal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead of gastrointestinal radiation oncology

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 21, 2019

Study Start

May 9, 2018

Primary Completion

May 9, 2022

Study Completion (Estimated)

May 9, 2027

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations

DE(1)