MR-simulation in Radiotherapy for Prostate Cancer

NCT ID: NCT03238170

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2023-06-30

Brief Summary

To assess the feasibility of acquiring an MR scan in the radiotherapy treatment position as part of the patient's radiotherapy pathway and incorporating the data into our radiotherapy planning systems, so that it can be potentially used to reduce healthy tissue exposure to radiation. Subsequently, the protocols and procedures established can be used to put the technique into routine clinical practice.

Detailed Description

Conventional radiotherapy treatment planning uses computed tomography (CT) scans to provide an accurate 3-D picture of the local anatomy. This helps the planners to maximise the radiation dose delivered to the prostate, whilst minimising the dose to surrounding normal tissue. Magnetic resonance imaging (MRI) scanning is an established diagnostic imaging technique that provides even clearer images of the local anatomy. However, until recently the technology hasn't existed to allow us to perform MRI scans with patients "set-up" in the position required to plan and deliver radiotherapy to the prostate. This study is being performed to assess methods that may allow us to incorporate MRI scans into the radiotherapy planning process, which may further increase the accuracy of the treatment, reducing the irradiation of surrounding normal tissue and minimising toxicity.

Conditions

Cancer of the PROSTATE

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MR-Simulation

Patients will have 1 MRI scan appointment, using the Siemens Aera® (Siemens AG Healthcare, Erlangen, Germany) on the same day as their treatment planning CT scan. The MR scan will be performed in the radiotherapy treatment position.

Group Type: EXPERIMENTAL

MRI scan

Intervention Type: DEVICE

MRI scan using the Siemens Aera® (Siemens AG Healthcare, Erlangen, Germany) on the same day as their treatment planning CT scan

Interventions

MRI scan

MRI scan using the Siemens Aera® (Siemens AG Healthcare, Erlangen, Germany) on the same day as their treatment planning CT scan

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Written, voluntary, informed consent
• Age ≥ 18
• ECOG Performance Status ≤ 2
• Life expectancy > 12 months
• Histologically proven carcinoma of the prostate
• Radical radiotherapy +/- hormones indicated as the primary treatment modality
• Staging diagnostic MRI of the prostate need to be available for comparison.
• Adequate organ function and absence of other major concurrent illness, allowing

Exclusion Criteria

• Inability to provide informed consent
• Impaired renal function (serum creatinine of > 200)
• Severely impaired liver function
• Patients with allergies or contra-indications to the gadolinium contrast agent that may be used in the study
• Severe claustrophobia or inability to tolerate MRI scans
• General contra-indications to MRI including cardiac pacemakers and defibrillators, metallic prosthetic devices, aneurysm clips and metal fragments in the eyes, as defined in MRI safety departmental protocols
• Serious inter-current conditions or other non-malignant illnesses that are uncontrolled or whose control may be affected by participation in this study
• Any patient who has urinary or faecal incontinence
• Status greater than or equal to 3

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Hughes

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Locations

Guy's and St. Thomas' NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

References

Thomas C, Dregely I, Oksuz I, Guerrero Urbano T, Greener T, King AP, Barrington SF. Effect of synthetic CT on dose-derived toxicity predictors for MR-only prostate radiotherapy. BJR Open. 2024 Jun 3;6(1):tzae014. doi: 10.1093/bjro/tzae014. eCollection 2024 Jan.

Reference Type: DERIVED

PMID: 38948455 (View on PubMed)

Other Identifiers

215681

Identifier Type: -

Identifier Source: org_study_id