A Feasibility Study of MRI Guided Stereotactic Ablative Radiotherapy (MIDSECTION)

NCT05903430 | Recruiting

• 1 other identifier: CFTsp194
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if the investigators are able to deliver highly focused, intense radiation to tumours in the abdominal region or chest cavity whilst limiting the dose to surrounding organs using a high field strength MR-Linac.

Conditions

Abdominal Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• > 85% success in delivery and completion of radiotherapy to patients recruited on protocol

  30 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Either patient with abdominal cancer or centrally located lung cancer eligible for SABR

You may qualify if:

• Have no MRI contra-indications.
• Eligible for abdominal SABR in accordance with the NHSE SABR Consortium Guidelines or eligible for central lung SABR in accordance with RTOG Guidelines.
• Be able to give informed consent.
• Anticipated life-expectancy \> 6 months.
• Not more than 3 oligmetastatic sites treated in total per patients.
• Performance status ≤ 2.
• Willing to attend follow-up and have details collected on prospective basis for a minimum of 1 year.

You may not qualify if:

• Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.
• Unable to tolerate MRI scans.
• Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator make it undesirable for the patient to participate in the study.
• Any evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator, make it undesirable for the patient to participate in the study.
• Any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV).

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, United Kingdom, M204BX, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The optional biospecimens collected and stored from patients will include some or all of the following; tissue in the form of a diagnostic block (likely Formalin Fixed Paraffin Embedded FFPE), whole blood.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Clare Griffin

CONTACT

01614463000; clare.griffin1@nhs.net

Cynthia Eccles

CONTACT

cynthia.eccles1@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: August 29, 2025
• Primary Completion (Estimated): January 29, 2027
• Study Completion (Estimated): January 29, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)