Skip to content
GeoClinicalTrials
Back to search

NCT07021573Not yet recruiting

Protoporphyrin Imaging in Multispectral Evaluation of Resections

Official recordSimplified version

Summary

Observational non-interventional investigation to evaluate the potential of multispectral imaging in improving tumor visualization.

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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Not yet recruiting
Phase
No phase (N/A)
Study type
Interventional
Countries
Switzerland, Germany, Austria
Sponsor
Medical University Innsbruck(Other)
Protocol no.
PRIMER
Conditions
Glioma
Interventions
Device

Treatments studied

  • KINEVO 900 S with BLUE 400

Locations · 10

  • Bern, SwitzerlandInselspital Bern, Universitätsklinik für NeurochirurgieNot yet recruiting at this site
  • Geneva, SwitzerlandHôpitaux universitaires de Genève - NeuroCentreNot yet recruiting at this site
  • Berlin, GermanyCharité - Universitätsmedizin BerlinNot yet recruiting at this site
  • Freiburg im Breisgau, GermanyUniversitätsklinikum Freiburg - Klinik für Neurochirurgie im NeurozentrumNot yet recruiting at this site
  • Göttingen, GermanyUniversitätsklinikum Göttingen - Neurochirurgische KlinikNot yet recruiting at this site
  • München, GermanyKlinik und Poliklinik für Neurochirurgie, LMU Klinikum MünchenNot yet recruiting at this site
  • München, GermanyKlinikum rechts der Isar der Technischen Universität MünchenNot yet recruiting at this site
  • Münster, GermanyUniversitätsklinikum Münster - Klinik für NeurochirurgieNot yet recruiting at this site
  • Tübingen, GermanyUniversitätsklinikum Tübingen, Universitätsklinik für NeurochirurgieNot yet recruiting at this site
  • Innsbruck, AustriaUniversitätsklinik für Neurochirurgie der Medizinischen Universität InnsbruckNot yet recruiting at this site

In total, worldwide, all 10 sites listed in the registry are planned; recruitment has not opened yet.

Site status per the ClinicalTrials.gov registry (last update posted: September 9, 2025).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.