Clinical trial · Interventional

MR-Linac for Head and Neck SBRT

Magnetic Resonance Imaging-Guided Radiotherapy for Head & Neck SBRT on the 1.5T MR-Linac

NCT04809792CI-TRIAL-00066614not yet recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study will evaluate the feasibility and safety of using MR-guided adaptive Head and Neck stereotactic radiotherapy (SBRT) at each fraction on the 1.5T MR-Linac.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
SBRT on the MR-Linac	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Head and neck cancer
description
In this arm patients with head and neck cancers treated with SBRT are recruited.
interventionNames
1. Radiation: SBRT on the MR-Linac

Primary outcomes (1)

measure
Proportion of patients who complete ≥80% of treatment fractions in ≤60 minutes.
timeFrame
2 years
description
Clinical feasibility of delivering radiotherapy treatment on the MR Linac within 60 minutes and the need for patients to transfer to a CT-based linear accelerator will be monitored. The radiotherapy timing sheet will be used to record the length of time for patients to have their MR guided adaptive radiotherapy for each fraction.

Secondary outcomes (10)

measure
Dosimetric outcomes in HN SBRT patients treated with MR-guided adaptation as compared to non-adaptive HN SBRT.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Patients aged 18 years and older
* Karnofsky performance status score of ≥70
* Biopsy-proven oligometastatic cancer to the HN
* Biopsy-proven primary HN cancer (either mucosal, nodal, skin)
* Patients deemed unsuitable by the treating radiation oncologist for radiation treatment with curative intent owing to advanced age, significant comorbidities, poor performance status, distant metastatic disease.
* ≥ 1 site amenable to HN SBRT
* Capable of providing informed consent
* Required to complete any systemic therapy ≥ 10 days prior to planned start of HN SBRT, with no plans to initiate systemic therapy ≥10 days following completion of HN SBRT.

Exclusion Criteria:

* History of radiation within the projected treatment field
* Contraindications to MR imaging per institutional policy
* Patients with connective tissue disorders
* History of severe claustrophobia
* Pregnant and or breastfeeding females
* Having an estimated glomerular filtration rate (GFR) \<40 ml/min/1.73m2

References

Publications (0)

Data not yet available

No reference posted for this study.