Clinical trial · Observational
Fluorescence, Light-microscopy, Ultrasound Integrated / Intraoperative Diagnosis to MAXimise Resection
NCT05330559CI-TRIAL-00057856FLUID-MAXunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present study aims to evaluate and compare with the histopathological analysis the various margin-assessment systems, including ultrasound, florescence, brightfield vision, new optical filters and microscope image post-processing systems, for the treatment of High Grade Gliomas (HGGs)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With Radiological, Clinical and Anamnestic Picture Compatible With a New Diagnosis of Glioblastoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluid MAX group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary Outcome
- timeFrame
- year 2
- description
- Evaluation of Sensitivity and Specificity of individual techniques (bright field observation, 5-ALA FGS and ioUS) in detecting tumor infiltration quantified by histopathological examination.
Secondary outcomes (1)
- measure
- Secondary Outcome
- timeFrame
- year 2
- description
- Conduct a feasibility study on the use of the above techniques in sequence described;
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: Patients with radiological, clinical and anamnestic picture compatible with a new diagnosis of Glioblastoma for whom there is an indication for cytoreductive surgery at the Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. Exclusion Criteria: * Patients aged less than 18 years at the time of radiological diagnosis * Patients who have received radiation therapy in the same area as the neoplasm of interest * Patients contraindicated to 5-ALA administration * Patients whose neoplasm is in close proximity to functionally eloquent areas (Primary Motor, Broca's, Wernicke's areas) * Patients who have not given their consent to take part in the research
References
Publications (8)
- BACKGROUNDChaichana KL, Jusue-Torres I, Navarro-Ramirez R, Raza SM, Pascual-Gallego M, Ibrahim A, Hernandez-Hermann M, Gomez L, Ye X, Weingart JD, Olivi A, Blakeley J, Gallia GL, Lim M, Brem H, Quinones-Hinojosa A. Establishing percent resection and residual volume thresholds affecting survival and recurrence for patients with newly diagnosed intracranial glioblastoma. Neuro Oncol. 2014 Jan;16(1):113-22. doi: 10.1093/neuonc/not137. Epub 2013 Nov 26. PMID 24285550
- BACKGROUNDPino MA, Imperato A, Musca I, Maugeri R, Giammalva GR, Costantino G, Graziano F, Meli F, Francaviglia N, Iacopino DG, Villa A. New Hope in Brain Glioma Surgery: The Role of Intraoperative Ultrasound. A Review. Brain Sci. 2018 Nov 19;8(11):202. doi: 10.3390/brainsci8110202. PMID 30463249
- BACKGROUNDMahboob S, McPhillips R, Qiu Z, Jiang Y, Meggs C, Schiavone G, Button T, Desmulliez M, Demore C, Cochran S, Eljamel S. Intraoperative Ultrasound-Guided Resection of Gliomas: A Meta-Analysis and Review of the Literature. World Neurosurg. 2016 Aug;92:255-263. doi: 10.1016/j.wneu.2016.05.007. Epub 2016 May 10. PMID 27178235
- BACKGROUNDStepp H, Stummer W. 5-ALA in the management of malignant glioma. Lasers Surg Med. 2018 Jul;50(5):399-419. doi: 10.1002/lsm.22933. Epub 2018 May 8. PMID 29737540
- BACKGROUNDKiesel B, Mischkulnig M, Woehrer A, Martinez-Moreno M, Millesi M, Mallouhi A, Czech T, Preusser M, Hainfellner JA, Wolfsberger S, Knosp E, Widhalm G. Systematic histopathological analysis of different 5-aminolevulinic acid-induced fluorescence levels in newly diagnosed glioblastomas. J Neurosurg. 2018 Aug;129(2):341-353. doi: 10.3171/2017.4.JNS162991. Epub 2017 Oct 27. PMID 29076783
- BACKGROUNDDel Bene M, Perin A, Casali C, Legnani F, Saladino A, Mattei L, Vetrano IG, Saini M, DiMeco F, Prada F. Advanced Ultrasound Imaging in Glioma Surgery: Beyond Gray-Scale B-mode. Front Oncol. 2018 Dec 3;8:576. doi: 10.3389/fonc.2018.00576. eCollection 2018.