Clinical trial · Interventional
Protoporphyrin Imaging in Multispectral Evaluation of Resections
NCT07021573CI-TRIAL-00094797PRIMERnot yet recruitingN/AClinicalTrials.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)
Observational non-interventional investigation to evaluate the potential of multispectral imaging in improving tumor visualization.
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 |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KINEVO 900 S with BLUE 400 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- GMB like or LGG like
- description
- There are 2 groups: group 1 (GBM-like) includes patients with high-grade gliomas and significant contrast enhancement on preoperative MRI. Group 2 (LGG-like) will include patients with suspected HGG and little to no contrast enhancement.
- interventionNames
- Device: KINEVO 900 S with BLUE 400
Primary outcomes (1)
- measure
- Primary objective
- timeFrame
- 12 months
- description
- Detection of Tumor cells and fluorescence in biopsied tissue
Secondary outcomes (1)
- measure
- Secondary objectives
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion criteria: * Age Requirement: Patients must be 18 years of age or older. * Diagnosis: Patients with a preoperative diagnosis of a suspected high-grade glioma based demographics and MRI imaging. * MRI Findings: Patients must meet one of the following criteria: * Group 1: Suspected high-grade glioma with contrast enhancement on MRI (GBM-like). * Group 2: Suspected high-grade glioma without contrast enhancement on MRI (LGG-like). * Surgical Resection: Patients scheduled to undergo surgical resection of the tumor as part of standard treatment. * 5-ALA Administration: Patients who will receive 5-aminolevulinic acid (5-ALA) for fluorescence guidance during surgery. * Post-op MRI: Patients who are able to undergo pre- and postoperative MRI (standard of care at the center). * Informed Consent: Patients who are able to understand and provide written informed consent prior to enrollment in the study. * Eligibility for Multispectral Imaging: Patients whose surgical procedures allow for the use of multispectral imaging technology for tumor visualization. * Performance Status: Patients with a Karnofsky Performance Status (KPS) of 60 or greater, indicating that they are capable of at least limited self-care. * No Prior Treatment: Patients who have not received prior treatment for the current brain tumor, including surgery, radiotherapy, or chemotherapy. Exclusion criteria: * Patients with a known allergy or contraindication to 5-aminolevulinic acid (5-ALA) or its components. * Use of all other fluorescent markers. * Patients with a history of porphyria or other disorders related to 5-ALA metabolism. * Patients with recurrent gliomas or those who have received prior treatment for their current brain tumor, including surgery, radiotherapy, or chemotherapy. * Pregnant or breastfeeding patients, due to potential risks associated with 5-ALA administration. * Patients with severe comorbidities or other medical conditions that, in the investigator's opinion, would pose an unacceptable risk or compromise the safety of participation in the study. * Patients with a Karnofsky Performance Status (KPS) below 60, indicating an inability to perform minimal self-care. * Patients with a history of severe hepatic or renal impairment that may impact the metabolism of 5-ALA. * Patients unable to undergo MRI imaging for any reason (e.g., presence of non-MRI-compatible implants). * Patients unable to provide written informed consent due to cognitive, language, or other barriers. * Patients with tumors located in regions where fluorescence imaging is not technically feasible or where the use of multispectral imaging could interfere with the standard surgical approach. * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.