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Functional and Ultrasound Guided Resection of Glioblastoma

Study Purpose

Functional and ultrasound-guided resection of glioblastoma: assessing the use of additional imaging during surgery to improve outcomes for patients with glioblastoma brain tumours

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age 18-70 years.
  • - Neuro-oncology Multi-Disciplinary Team (MDT) decision that the imaging shows a primary GB tumour which is maximally resectable (attempted gross total resection of all enhancing tumour) - Patient is suitable for concomitant adjuvant radiotherapy and Temozolomide (TMZ) chemotherapy or adjuvant TMZ at the time of MDT decision.
  • - Able to receive 5-ALA.
  • - Willing and able to give informed consent.
  • - Able to complete trial questionnaires, this may be with support where English is not their first language.
(Stage 2 only)
  • - Able to provide a proxy who is willing to complete questionnaires as requested (Stage 2 only).

Exclusion Criteria:

  • - Midline/basal ganglia/cerebellum/brainstem GB.
  • - Multifocal GB.
  • - Recurrent GB.
  • - Suspected secondary GB.
- Contraindication to MRI

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05399524
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Oxford
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Puneet Plaha
Principal Investigator Affiliation University of Oxford
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma Glioblastoma Multiforme
Additional Details

Stage 1 (IDEAL IIB study) of the trial is observational only and all participants will receive all technologies during surgery. Stage 2 will be randomised. Randomisation will be via the web-based service provided by the Oxford Clinical Trials Research Unit (OCTRU), using the method of minimisation. Participants will be randomised 1:1 to either: 1. Standard care surgery (neuronavigation based on preoperative imaging and intraoperative use of 5-ALA)(Control arm) 2. Standard care surgery (neuronavigation based on preoperative imaging and intraoperative use of 5-ALA) AND of DTI neuronavigation and NiUS (Intervention arm) At baseline all participants will undergo a routine preoperative neuronavigation MRI scan. Those participants randomised to the experimental arm, will also have a DTI scan (additional 5 minutes in the MRI). All participants will then undergo the planned resection of their tumour, with the additional technologies if they are in the experimental arm. Following surgery, participants in both arms have the same follow up schedule and undergo standard clinical care for a total of 24 months.

Arms & Interventions

Arms

Experimental: Additional pre- and intra-operative imaging

Surgery to resect the GB using Diffusion Tensor Imaging (DTI) and intraoperative Ultrasound (iUS) (navigated iUS where available) in addition to standard care (i.e. neuronavigation based on preoperative MRI and intraoperative use of 5-aminolevulinic acid (5-ALA))

Active Comparator: Standard of Care

The comparator is standard care as per current NICE guidelines (i.e. neuronavigation based on preoperative MRI and intraoperative use of 5-ALA).

Interventions

Other: - Standard of Care

Neuronavigation and intraoperative 5-ALA

Other: - Additional pre- and intra-operative imaging

Additional DTI scan during routine pre-operative tumour MRI scan, additional use of intraoperative ultrasound in addition to normal to standard of care (Neuronavigation and intraoperative 5-ALA)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Birmingham, United Kingdom

Status

Not yet recruiting

Address

Queen Elizabeth Hospital, University Hospitals Birmingham NHSFT

Birmingham, , B15 2TH

Site Contact

Colin Watts

c.watts.2@bham.ac.uk

44 7917 101 649

Royal Sussex County Hospital, Brighton, United Kingdom

Status

Not yet recruiting

Address

Royal Sussex County Hospital

Brighton, , BN2 5BE

Site Contact

Giles Critchley

giles.critchley@nhs.net

44 7917 101 649

Southmead Hospital, North Bristol NHST, Bristol, United Kingdom

Status

Recruiting

Address

Southmead Hospital, North Bristol NHST

Bristol, , BS10 5NB

Site Contact

Neil Barua

neilbarua@doctors.org.uk

44 7917 101 649

Cambridge, United Kingdom

Status

Recruiting

Address

Addenbrookes Hospital, Cambridge University NHSFT

Cambridge, , CB2 0QQ

Site Contact

Stephen Price

sjp58@cam.ac.uk

44 7917 101 649

Cardiff, United Kingdom

Status

Recruiting

Address

University Hospital of Wales, Cardiff & Vale University Health Board

Cardiff, , CF14 4XW

Site Contact

George Eralil

george.eralil@wales.nhs.uk

44 7917 101 649

University Hospital, Coventry, Coventry, United Kingdom

Status

Not yet recruiting

Address

University Hospital, Coventry

Coventry, , CV2 2DX

Site Contact

Sandeep Solanki

Sandeep.Solanki@uhcw.nhs.uk

44 7917 101 649

Ninewells Hospital, NHS Tayside, Dundee, United Kingdom

Status

Recruiting

Address

Ninewells Hospital, NHS Tayside

Dundee, , DD2 1SG

Site Contact

Anna Solth

anna.solth1@nhs.scot

44 7917 101 649

Edinburgh, United Kingdom

Status

Recruiting

Address

The Royal Infirmary of Edinburgh, NHS Lothian

Edinburgh, , EH16

Site Contact

Paul Brennan

paul.brennan@ed.ac.uk

44 7917 101 649

Hull Royal Infirmary, Hull, United Kingdom

Status

Recruiting

Address

Hull Royal Infirmary

Hull, , HU3 2JZ

Site Contact

Chittoor Rajaraman

chittoor.rajaraman@nhs.net

44 7917 101 649

Leeds General Infirmary, Leeds, United Kingdom

Status

Recruiting

Address

Leeds General Infirmary

Leeds, , LS1 3EX

Site Contact

Robert Corns

robertcorns@nhs.net

44 7917 101 649

The Walton Centre, Liverpool, United Kingdom

Status

Recruiting

Address

The Walton Centre

Liverpool, , L9 7LJ

Site Contact

Michael Jenkinson

Michael.Jenkinson@liverpool.ac.uk

44 7917 101 649

London, United Kingdom

Status

Recruiting

Address

Royal London Hospital, Barts Health NHS Trust

London, , E1 1BB

Site Contact

Edward McKintosh

edward.mckintosh@nhs.net

44 7917 101 649

King's College Hospital, London, United Kingdom

Status

Recruiting

Address

King's College Hospital

London, , SE5 9RS

Site Contact

Keyoumars Ashkan

k.ashkan@nhs.net

44 7917 101 649

London, United Kingdom

Status

Recruiting

Address

Charing Cross Hospital/St Mary's, Imperial College Healthcare NHS Trust

London, , W6 8RF

Site Contact

Sophie Camp

sophie.camp@nhs.net

44 7917 101 649

Middlesbrough, United Kingdom

Status

Recruiting

Address

James Cook University Hospital, South Tees Hospitals NHSFT

Middlesbrough, , TS4 3BW

Site Contact

Anil Varma

anil.varma@nhs.net

44 7917 101 649

Newcastle Upon Tyne, United Kingdom

Status

Not yet recruiting

Address

Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHSFT

Newcastle Upon Tyne, , NE1 4LP

Site Contact

Damian Holliman

damian.holliman@nhs.net

44 7917 101 649

Nottingham, United Kingdom

Status

Recruiting

Address

Queen's Medical Centre, Nottingham University Hospitals NHST

Nottingham, , NG7 2UH

Oxford, United Kingdom

Status

Recruiting

Address

The John Radcliffe Hospital, Oxford University Hospitals NHSFT

Oxford, , OX3 9DU

Site Contact

Puneet Plaha

Puneet.plaha@ouh.nhs.uk

44 7917 101 649

Plymouth, United Kingdom

Status

Recruiting

Address

Derriford Hospital, University Hospitals Plymouth NHS Trust

Plymouth, , PL6 8DH

Site Contact

James Palmer

jamespalmer1@nhs.net

44 7917 101 649

Preston, United Kingdom

Status

Not yet recruiting

Address

Royal Preston Hospital, Lancashire Teaching Hospitals NHSFT

Preston, , PR2 9HT

Site Contact

Isaac Phang

Isaac.Phang@LTHTR.nhs.uk

44 7917 101 649

Romford, United Kingdom

Status

Not yet recruiting

Address

Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHST

Romford, , RM7 0AG

Site Contact

Nik Haliasos

n.haliasos@nhs.net

44 7917 101 649

Sheffield, United Kingdom

Status

Not yet recruiting

Address

Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , S10 2JF

Site Contact

Yahia Al-Tamimi

yahia.al-tamimi@nhs.net

44 7917 101 649

Southampton, United Kingdom

Status

Recruiting

Address

Southampton General Hospital, University Hospital Southampton NHSFT

Southampton, ,

Site Contact

Paul Grundy

paul.grundy@nhs.net

44 7917 101 649

Stoke-on-Trent, United Kingdom

Status

Recruiting

Address

Royal Stoke University Hospital, University Hospitals of North Midlands NHST

Stoke-on-Trent, , ST4 6QG

Site Contact

Erminia Albanese

Erminia.Albanese@uhnm.nhs.uk

44 7917 101 649