GliomaPIGMINCT04738110
Post-operative Imaging in High Grade Glioma: is Management Influenced?
An observational study of Glioma, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Magnetic resonance imaging (MRI) is likely to play an important role in the management of high grade glioma. Appropriate and timely neuroimaging in the follow up period is believed to be crucial in making subsequent management decisions. However, there is a paucity in the literature providing evidence to support this. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- MRI
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jul 2020to 16 Dec 2022
- 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: HGG (Grade III and IV WHO criteria) patients discussed in MDTM between March 2018 and March 2020 at KCH and NHNN are being studied.
Who may be able to join
- Histologically proven HGG patients (Grade III and IV WHO criteria)
- Underwent surgery, radiotherapy and chemotherapy regimen according to 2018 NICE guidelines (1)
- >=18 years old
- Has follow-up MRI imaging (T1, T2, FLAIR and T1 with contrast enhancement) and also DSC and DCE imaging
- Evaluated at MDT meetings between March 2018 and March 2020.
Who cannot join
- Patients who have insufficient clinical and radiological follow-up
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King´s College Hospital NHS Foundation trust
London, SE5 9RS
Thomas Booth
About this study
Magnetic resonance imaging (MRI) is likely to play an important role in the management of high grade glioma. Appropriate and timely neuroimaging in the follow up period is believed to be crucial in making subsequent management decisions. However, there is a paucity in the literature providing evidence to support this. The aim of this study is to determine whether neuroimaging performed at each component of the patient pathway after initial high grade glioma treatment, actually results in a real change in management (as opposed to a perceived change in management). The main emphasis is on all imaging used at the time of a MDM, however, we will also study specifically dynamic susceptibility contrast-enhanced (DSC) MRI and dynamic contrast enhanced (DCE) MRI.
The study is in the format of Mock MDMs to be compatible with real life decision making. Using retrospective identical information available at the MDM i.e. compiled recent correspondence, histopathological and molecular information, the MDM members (oncology nurse, oncologist, neurosurgeon, neuroradiologist, pathologist/molecular scientist) will prospectively determine the patient management with and without the imaging.
- Conditions
- Glioma
- Being tested
- MRI
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Structural MR (T2, FLAIR, T1 and T1+C), DCE, DSC
| Study group | Role | What they receive |
|---|---|---|
| KCH patients | 75 high grade glioma patients from KCH Receives: Other: MRI | |
| NHNN patients | 75 high grade glioma patients from NHNN Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine how MR imaging influences the management of HGG patients
Measured: 12 months
Secondary outcomes (1)
Determine how advanced MR imaging influences the management of HGG patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start20 Jul 2020
- Primary completion16 Dec 2022 (estimated)
- Study completion16 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738110
- Sponsor's protocol ID
- KCH20-139
- Acronym
- PIGMI
- Status last verified
- Mar 2022
- First submitted
- 1 Feb 2021
- Last updated
- 31 Mar 2022
- Results posted
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Imaging in High Grade Glioma: is Management Influenced?
- ClinicalTrials.gov ID
- NCT04738110
- Acronym / sponsor ID
- PIGMI / KCH20-139
- Conditions
- Glioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 16 Dec 2022 (estimated)
- Study completion
- 16 Dec 2022 (estimated)
- First posted
- 4 Feb 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.
Magnetic resonance imaging (MRI) is likely to play an important role in the management of high grade glioma. Appropriate and timely neuroimaging in the follow up period is believed to be crucial in making subsequent management decisions. However, there is a paucity in the literature providing evidence to support this. The aim of this study is to determine whether neuroimaging performed at each component of the patient pathway after initial high grade glioma treatment, actually results in a real change in management (as opposed to a perceived change in management). The main emphasis is on all imaging used at the time of a MDM, however, we will also study specifically dynamic susceptibility contrast-enhanced (DSC) MRI and dynamic contrast enhanced (DCE) MRI.
The study is in the format of Mock MDMs to be compatible with real life decision making. Using retrospective identical information available at the MDM i.e. compiled recent correspondence, histopathological and molecular information, the MDM members (oncology nurse, oncologist, neurosurgeon, neuroradiologist, pathologist/molecular scientist) will prospectively determine the patient management with and without the imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KCH patients | – | Other: MRI75 high grade glioma patients from KCH |
| NHNN patients | – | Other: MRI75 high grade glioma patients from NHNN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HGG (Grade III and IV WHO criteria) patients discussed in MDTM between March 2018 and March 2020 at KCH and NHNN are being studied.
Key inclusion criteria (5 listed)
- Histologically proven HGG patients (Grade III and IV WHO criteria)
- Underwent surgery, radiotherapy and chemotherapy regimen according to 2018 NICE guidelines (1)
- >=18 years old
- Has follow-up MRI imaging (T1, T2, FLAIR and T1 with contrast enhancement) and also DSC and DCE imaging
- Evaluated at MDT meetings between March 2018 and March 2020.
Key exclusion criteria (1 listed)
- Patients who have insufficient clinical and radiological follow-up
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 |
|---|---|---|
| MRIStructural MR (T2, FLAIR, T1 and T1+C), DCE, DSC | Other | KCH patients, NHNN patients |
Primary outcome
Determine how MR imaging influences the management of HGG patients
Time frame: 12 months
1 secondary outcome
Determine how advanced MR imaging influences the management of HGG patients
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 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.
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 Glioma, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Booth (02032994828, thomasbooth@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine how MR imaging influences the management of HGG patients (time frame: 12 months). 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 31 Mar 2022.