Prostate CancerPRISNCT04704804
Feasibility of MRI Workflow Alone in External Radiotherapy for the Treatment of Brain and Prostate Tumors
An observational study of Prostate Cancer and Brain Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
In radiotherapy, Magnetic Resonance Imaging (MRI) is used as a complement to the CT scanner because it provides better tissue contrast and therefore more precise delineations without the need for additional irradiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Brain Cancer
- What is being tested?
- Synthetic CT Scan
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2020to 15 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with prostate or brain cancer receiving an MRI in addition to the simulated CT scan prior to the start of their external radiotherapy treatment
Who may be able to join
- Age ≥ 18 years old
- Male or Female with a (primary) brain tumour or Male with cancer and localized (non-metastatic) prostate cancer
- Patient having benefited from a planning MRI scan in treatment position performed according to the new acquisition modalities (allowing the generation of CT-synthetics by automatic assignment of densities) performed since January 2020 and a planning scanner in treatment position prior to external radiotherapy.
- Good general condition (SP < 3)
Who cannot join
- Excluded forms of the disease,
- MRI-specific contraindications (claustrophobia, foreign bodies)
- Obesity preventing the placement of equipment (contention/antennae)
- Poor general condition (SP > or = 2) preventing the patient from standing on the table -
Trial locations and contacts
1 site in 1 country.
About this study
In radiotherapy, Magnetic Resonance Imaging (MRI) is used as a complement to the CT scanner because it provides better tissue contrast and therefore more precise delineations without the need for additional irradiation. However, MRI does not allow the definition of the electronic densities of the tissues necessary for dose calculation.
In this work, we sought to measure the feasibility of a method for generating CT-synthetic images from MRI in terms of dosimetric and geometrical precision for the purpose of MRI workflow alone (see diagram). The cerebral sphere and the prostate are the two tumor locations considered. All patients will have a planning CT (reference) and an MRI in the treatment position. The contours of the structures will be contoured by a radiotherapist on both the MRI and the reference CT. Synthetic CTs will be generated from the MRI with the method of automatic assignment of densities in five classes. The volumes bypassed and the dosimetries performed will be compared. A study of the quality of the images generated from MRI for dose calculation and images for the verification of per-treatment positioning will be performed.
Read the detailed description
This is a prospective single-center dosimetry study that exhaustively included brain tumor and prostate cancer patients treated at the ICO Site d'Angers by external radiotherapy and prior to which they were given an MRI and a simulation CT in treatment position over a 12-month period.
For patients who agree to participate in the study, CT-synthetic images will be generated from the MRI images by automatic assignment of densities (5 classes).
Reference CT images from CT and synthetic CT images from MRI will be available for comparison for all eligible patients.
- Conditions
- Prostate Cancer, Brain Cancer
- Being tested
- Synthetic CT Scan
- Medical subject headings
- Prostatic Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic CT ScanDiagnostic test
method of generating CT-synthetic image from MRI
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer | Man with cancer and localized (non-metastatic) prostate cancer Receives: Diagnostic Test: Synthetic CT Scan | |
| Brain cancer | Male or Female with a brain tumor (primitive) Receives: Diagnostic Test: Synthetic CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
describe the differences in volumetric and dosimetric accuracy between potential planning from MRI alone by CT-synthetics generation and standard planning from CT
Comparison of the contours of target volumes and organs at risk and comparison of dose distributions (dosimetries)
Measured: 3 month
Secondary outcomes (1)
Measurement of the quality of images generated from MRI for dose calculation and images for verification of per-treatment positioning relative to the reference CT in an MRI-only workflow objective.
Comparison of CT-synthetic CT images generated from MRI to the reference CT and Comparison of shifts performed during patient repositioning
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start24 Jul 2020
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien AUTRET, Principal investigator, INSTITUT DE CANCEROLOGIE DE L'OUEST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704804
- Sponsor's protocol ID
- ICO-2020-09
- Acronym
- PRIS
- Status last verified
- Mar 2022
- First submitted
- 8 Jan 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of MRI Workflow Alone in External Radiotherapy for the Treatment of Brain and Prostate Tumors
- ClinicalTrials.gov ID
- NCT04704804
- Acronym / sponsor ID
- PRIS / ICO-2020-09
- Conditions
- Prostate Cancer, Brain Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In radiotherapy, Magnetic Resonance Imaging (MRI) is used as a complement to the CT scanner because it provides better tissue contrast and therefore more precise delineations without the need for additional irradiation. However, MRI does not allow the definition of the electronic densities of the tissues necessary for dose calculation.
In this work, we sought to measure the feasibility of a method for generating CT-synthetic images from MRI in terms of dosimetric and geometrical precision for the purpose of MRI workflow alone (see diagram). The cerebral sphere and the prostate are the two tumor locations considered. All patients will have a planning CT (reference) and an MRI in the treatment position. The contours of the structures will be contoured by a radiotherapist on both the MRI and the reference CT. Synthetic CTs will be generated from the MRI with the method of automatic assignment of densities in five classes. The volumes bypassed and the dosimetries performed will be compared. A study of the quality of the images generated from MRI for dose calculation and images for the verification of per-treatment positioning will be performed.
Detailed description
This is a prospective single-center dosimetry study that exhaustively included brain tumor and prostate cancer patients treated at the ICO Site d'Angers by external radiotherapy and prior to which they were given an MRI and a simulation CT in treatment position over a 12-month period.
For patients who agree to participate in the study, CT-synthetic images will be generated from the MRI images by automatic assignment of densities (5 classes).
Reference CT images from CT and synthetic CT images from MRI will be available for comparison for all eligible patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer | – | Diagnostic Test: Synthetic CT ScanMan with cancer and localized (non-metastatic) prostate cancer |
| Brain cancer | – | Diagnostic Test: Synthetic CT ScanMale or Female with a brain tumor (primitive) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with prostate or brain cancer receiving an MRI in addition to the simulated CT scan prior to the start of their external radiotherapy treatment
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Male or Female with a (primary) brain tumour or Male with cancer and localized (non-metastatic) prostate cancer
- Patient having benefited from a planning MRI scan in treatment position performed according to the new acquisition modalities (allowing the generation of CT-synthetics by automatic assignment of densities) performed since January 2020 and a planning scanner in treatment position prior to external radiotherapy.
- Good general condition (SP < 3)
Key exclusion criteria (4 listed)
- Excluded forms of the disease,
- MRI-specific contraindications (claustrophobia, foreign bodies)
- Obesity preventing the placement of equipment (contention/antennae)
- Poor general condition (SP > or = 2) preventing the patient from standing on the table -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synthetic CT Scanmethod of generating CT-synthetic image from MRI | Diagnostic test | Brain cancer, Prostate cancer |
Primary outcome
describe the differences in volumetric and dosimetric accuracy between potential planning from MRI alone by CT-synthetics generation and standard planning from CT
Time frame: 3 month
Comparison of the contours of target volumes and organs at risk and comparison of dose distributions (dosimetries)
1 secondary outcome
Measurement of the quality of images generated from MRI for dose calculation and images for verification of per-treatment positioning relative to the reference CT in an MRI-only workflow objective.
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damien AUTRET principal investigator
INSTITUT DE CANCEROLOGIE DE L'OUEST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Brain Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
describe the differences in volumetric and dosimetric accuracy between potential planning from MRI alone by CT-synthetics generation and standard planning from CT (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.