NCT04556929

Brief Summary

The purpose of this study is to determine whether use of an ultra-high sensitivity camera with enhanced imaging technology can be used during surgery to detect areas of brain tissue affected by diffuse glioma, a type of brain cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 30, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2021

Completed
Last Updated

March 22, 2024

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

July 30, 2020

Last Update Submit

March 20, 2024

Conditions

Glioma

Keywords

5-Aminolevulinic acid (5-ALA)Malignant gliomaTumor resection

Outcome Measures

Primary Outcomes (1)

  • Level of tumour fluorescence in images of resection cavity captured during surgery

    Levels of tumour fluorescence in intra-operative images of the resection cavity taken by the ultra-high sensitivity camera and the in-built camera in the operative microscope will be measured. These fluorescence levels will then be used to calculate the sensitivity and specificity of the in-built camera and ultra-high sensitivity camera to detect glioma tissue.

    Intra-operative

Secondary Outcomes (1)

  • Duration of operation stages

    Intra-operative

Study Arms (1)

Intraoperative imaging of 5-ALA during tumour resection

EXPERIMENTAL

Participants will undergo 5-ALA guided tumour resection via craniotomy with the aim of achieving maximal safe tumour resection without significant neurological deficit. On completion of tumour resection, digital images will be taken of the resection cavity under blue light using (i) an in-built camera in the operative microscope and (ii) an ultra-high sensitivity camera attached to the side arm of the operative microscope. Biopsies approximately 5x5x5mm in size will then be taken from the anterior, posterior, lateral and inferior areas of the resection cavity which were imaged. These biopsies will be analysed by histopathology to determine the presence of glioma cells.

Diagnostic Test: Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity cameraDiagnostic Test: Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope cameraDiagnostic Test: Biopsies

Interventions

Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity cameraDIAGNOSTIC_TEST

An ultra-high sensitivity camera attached to the side arm of the operative microscope will be used to take images of the anterior, posterior, lateral and inferior walls of the resection cavity on completion of tumour resection.

Intraoperative imaging of 5-ALA during tumour resection
Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope cameraDIAGNOSTIC_TEST

In-built camera of the operative microscope will be used to take images of the anterior, posterior, lateral and inferior walls of the resection cavity on completion of tumour resection.

Intraoperative imaging of 5-ALA during tumour resection
BiopsiesDIAGNOSTIC_TEST

Following image capture, biopsies (approx 5x5x5mm size) will be taken from regions of the anterior, posterior, lateral and inferior walls of the resection cavity corresponding to the imaged areas.

Intraoperative imaging of 5-ALA during tumour resection

Eligibility Criteria

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

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Female patients are not pregnant at time of surgery.
  • Patient has consented to craniotomy for suspected glioma of any type with 5-ALA infusion.

You may not qualify if:

  • Participants are participating in another trial at time of operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Glioma

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Puneet Plaha, MD FRCS

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 30, 2020

First Posted

September 21, 2020

Study Start

September 21, 2020

Primary Completion

November 3, 2021

Study Completion

November 3, 2021

Last Updated

March 22, 2024

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Locations

GB(1)