Clinical trial · Observational
Spectral Analysis Probe to Identify Glioblastoma Cells
Pilot Study Utilizing a Spectral Analysis Probe to Identify Glioblastoma Cells in Patients With Glioblastoma Undergoing Standard Surgical Resection
NCT03293888CI-TRIAL-00036754terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI Relocation
Summary
Brief summary (as posted)
This is a pilot, observational study to evaluate the intraoperative sensitivity of the Chaos Wand in detecting tumor tissue with glioblastoma disease.
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 |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Mean ratio of detecting glioblastoma cancer between the Chaos Wand spectral readings and histopathology as ground truth
- timeFrame
- 6 months
- description
- For participants newly diagnosed with glioblastoma multiforme or patients who are suspected of having glioblastoma on pre-operative imaging who consent to the use of the Chaos Wand during surgery, 15-20 spectral readings will be compared to histopathology as ground truth to measure the sensitivity of the Chaos Wand to detect glioblastoma. For example, if a patient has 15 spectral readings but only 13 are histologically consistent with cancer, then the sensitivity of the wand would be 13/15\*100 = 87%. A mean value with standard deviation will be reported across all participants in the study.
Secondary outcomes (3)
- measure
- Number of participants experiencing post-operative intracranial hemorrhage following surgical resection of glioblastoma with use of the Chaos Wand during surgery
- timeFrame
- Up to 1 month following surgery
- description
- For participants newly diagnosed with glioblastoma multiforme or are suspected of having glioblastoma based on pre-operative imaging who consent to the use of the Chaos Wand during surgery, the number of cases of intracranial hemorrhage during the post-operative hospital course will be measured.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or Female and over 18 years of age. 2. Patients with histologically proven GBM who are newly diagnosed and eligible to undergo surgical treatment or patients who are suspected of having glioblastoma on pre-operative imaging which is subsequently confirmed by histopathology following tumor resection. 3. Patients must be able to understand and willing to sign the informed consent document. Exclusion Criteria: 1. Patients with absence of glioblastoma. 2. Patients who are not undergoing tumor resection. 3. Patients who have prior brain radiotherapy 4. Patients who have prior systemic chemotherapy 5. Patients who are not willing to sign the informed consent and agree to participate. 6. Patients who are pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.