NCT05397574

Brief Summary

The purpose of this study is to obtain images of brain tumours during surgery using a new type of surgical camera. The study will assess how the information obtained from the images during surgery matches the removed tissue. Data will also be used to develop the system's key computer-processing features. This will enable real-time information to be given to the surgeon whilst they are performing the procedure and has the potential to make neurosurgery safer and more precise.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

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

First Submitted

Initial submission to the registry

May 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

May 25, 2022

Last Update Submit

November 30, 2023

Conditions

NeurosurgeryNeuro-OncologyBrain Tumor

Outcome Measures

Primary Outcomes (1)

  • Correlation of qFHSI data with histological analysis of the corresponding biopsied pathological tissue

    To correlate ex vivo and in vivo qFHSI data with histological analysis of the corresponding biopsied glioma tissue

    6-12 months

Secondary Outcomes (4)

  • Safety of qFHSI in surgery

    24-36 months

  • Tissue diagnosis

    24 months

  • Accuracy of biophotonics algorithm

    24-36 months

  • Qualitative assessment

    24-36 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing glioma surgery

You may qualify if:

  • Adult patients aged 18 years and over
  • Patients with a diagnosis of a probable glioma (any grade), who are scheduled for elective surgery
  • Patients able to provide written informed consent

You may not qualify if:

  • Patients under 18 years of age
  • Patients who have previously had brain surgery
  • Patients unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

September 1, 2022

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

December 7, 2023

Record last verified: 2023-11

Locations

GB(1)