NCT03238170

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

March 1, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

6.3 years

First QC Date

March 7, 2017

Last Update Submit

March 17, 2022

Conditions

Cancer of the PROSTATE

Outcome Measures

Primary Outcomes (1)

  • Standard Operating Procedure (SOP) for MRI-simulation for prostate patients

    Write a Standard Operating Procedure (SOP) for MRI-scanning of prostate patients in the radiotherapy treatment position so that their data can be used in the treatment planning for either in-direct or MRI-only planning

    6 months

Secondary Outcomes (2)

  • Clinical Protocol for in-direct MRI planning for prostate

    6 months

  • Clinical Protocol for direct MRI-only planning for prostate

    18 months

Study Arms (1)

MR-Simulation

EXPERIMENTAL

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.

Device: MRI scan

Interventions

MRI scanDEVICE

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

MR-Simulation

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St. Thomas' NHS Foundation Trust

London, SE19RT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 38948455DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Simon Hughes

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2017

First Posted

August 3, 2017

Study Start

March 1, 2017

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)