Trial Outcomes & Findings for Evaluation of cCeLL-Ex Vivo Confocal Microscopy for Real-time Brain Tumor Diagnosis (NCT NCT06098248)
NCT ID: NCT06098248
Last Updated: 2025-12-15
Results Overview
The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 283 tumor specimens are presented below.
TERMINATED
NA
285 participants
From neurosurgical resection to permanent pathology (≈ 4 weeks)
2025-12-15
Participant Flow
Recruitment Status: Completed / Enrolled: 285 patients, 358 specimens, drop-out 36 speciments Study Start: Jan 1, 2023 , Primary y Completion: Nov 27, 2024 First enrollment: Korea: Jan 1, 2023 Canada: Jul 5, 2024 Enrollment ended: Korea: Nov 27, 2024 / Canada: Oct 18, 2024 Analyzed: 322 specimens Study Completion Date (database lock and QC): 31 Dec 2024
This was a single-group, assessor-blinded study with no randomization or run-in period. Adults (≥19) with suspected brain tumors who consented were enrolled. A total of 285 Patient at four sites (three in Korea, one in Canada) joined; Each could yield up to three specimens, resulting in 322 analyzable samples. No comparator was used, so all proceeded to cCeLL - Ex vivo. No extra screening or washout was performed.
Unit of analysis: specimens
Participant milestones
| Measure |
Participants
"All participants underwent the same imaging intervention (cCeLL - Ex vivo); Participant Flow counts are reported for both participants and the tissue-specimen units analyzed."
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|---|---|
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Overall Study
STARTED
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285 358
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Overall Study
COMPLETED
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271 322
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Overall Study
NOT COMPLETED
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14 36
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of cCeLL-Ex Vivo Confocal Microscopy for Real-time Brain Tumor Diagnosis
Baseline characteristics by cohort
| Measure |
CeLL - Ex Vivo Imaging
n=322 Specimens
All resected brain-tumor specimens were imaged in the operating room with cCeLL - Ex vivo, a confocal laser fluorescence endomicroscope that captures real-time, sub-cellular resolution images. Blinded expert pathologists interpreted the images on a secure workstation.
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|---|---|
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Age, Continuous
|
55.6 years
STANDARD_DEVIATION 14.6 • n=271 Participants
|
|
Sex: Female, Male
Female
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154 Participants
n=271 Participants
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Sex: Female, Male
Male
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117 Participants
n=271 Participants
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Baseline Number of Tissue Specimens Collected for cCeLL - Ex vivo Imaging
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322 Specimens
n=271 Participants
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PRIMARY outcome
Timeframe: From neurosurgical resection to permanent pathology (≈ 4 weeks)Population: Both tumor and non-tumor specimens were collected from 19 participants.
The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 283 tumor specimens are presented below.
Outcome measures
| Measure |
cCeLL - Ex vivo and Frozen Section
n=283 specimens
Sensitivity: 256 participants(283 tumor specimens)
|
|---|---|
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Clinical Sensitivity for Tumor Detection (Specimen-level)
cCeLL - Ex vivo
|
96.05 Percentage of tumor specimens (%)
Interval 92.8 to 98.3
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Clinical Sensitivity for Tumor Detection (Specimen-level)
Frozen section
|
94.81 Percentage of tumor specimens (%)
Interval 92.18 to 96.76
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PRIMARY outcome
Timeframe: From neurosurgical resection to permanent pathology (≈ 4 weeks)Population: Both tumor and non-tumor specimens were collected from 19 participants.
The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 39 normal specimens are as follows
Outcome measures
| Measure |
cCeLL - Ex vivo and Frozen Section
n=39 specimens
Sensitivity: 256 participants(283 tumor specimens)
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|---|---|
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Clinical Specificity for Tumor Detection (Specimen-level)
Frozen Section
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67.86 Percentage of normal specimens (%)
Interval 54.2 to 79.1
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Clinical Specificity for Tumor Detection (Specimen-level)
cCeLL - Ex vivo
|
78.57 Percentage of normal specimens (%)
Interval 65.0 to 89.9
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Adverse Events
Single Group: cCeLL - Ex vivo and Frozen Section
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place