Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06740097

Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery

Led by Kuopio University Hospital · Updated on 2024-12-18

50

Participants Needed

3

Research Sites

204 weeks

Total Duration

On this page

Sponsors

K

Kuopio University Hospital

Lead Sponsor

T

Tampere University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Gliomas are tumors that occur in all ages; they include the most common malign primary central nervous system tumors in developed countries. Gliomas are often aggressive, and their recommended treatment is surgical resection and chemoradiation. Complete tumor removal is challenging because of diffuse cell growth and the proximity of functionally critical tissues. Surgeons use 5-aminolevulinic acid (5-ALA) drug-induced fluorescence to visually detect tumor cells, which improves resection rates and delays tumor progression. Tumor cells are often left unnoticed because of visual obstacles or weak fluorescence, which may lead to local recurrence and reoperations. Surgical suction devices are used to remove cancerous tissues, but so far the suction aspirate tissues have not been routinely used in tissue detection. This multicenter controlled clinical trial investigates the clinical performance and outcomes of a new method for detecting tumor from the suction aspirates in near-real time based on 5-ALA induced fluorescence. The feedback from the aspirate tissue monitor (ATM) is expected to improve the identification of tumors, leading to fewer reoperations and better treatment outcomes.

CONDITIONS

Official Title

Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient admitted to neurosurgery department for surgical resection of a suspected high-grade glioma
  • Patients aged 18 years old or older
  • Informed consent obtained
Not Eligible

You will not qualify if you...

  • Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Actively Recruiting

2

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Actively Recruiting

3

Oslo University Hospital

Oslo, Norway

Not Yet Recruiting

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Research Team

S

Sami Puustinen, PhD

CONTACT

A

Antti-Pekka Elomaa, Docent

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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