Clinical trial · Interventional
Quantitative Margin Assessment Using High-resolution Positron Emission Tomography - Computed Tomograhy
NCT06726512CI-TRIAL-00083556qMAPnot 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)
The primary endpoint is the assessment of the clinical value of a novel high-resolution mobile PET-CT scanner for intraoperative margin assessment in oral squamous cell carcinoma, soft tissue sarcoma and osteosarcoma surgery. The predicted margin status will be correlated with the margin status determined with histopathology.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Squamous Cell Carcinoma (OSCC) | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.85 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| XEOS AURA 10 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 2 MBq 18F-FDG
- description
- Subjects are intravenously administered with 2.0 MBq/kg 18F-FDG, standard tracer used to diagnose and stage the malignancy. After standard of care excision of the primary tumor, a high-resolution PET-CT imaging of the fresh surgical specimen will be performed.
- interventionNames
- Device: XEOS AURA 10
Primary outcomes (1)
- measure
- The primary endpoint is to determine the margin detection rates of a novel high-resolution mobile PET-CT for intraoperative margin assessment in OSCC, STS, and OS surgery.
- timeFrame
- Postoperatively i.e. 7-10 working days
- description
- Tumor positive and negative margin detection rates of the novel high-resolution mobile PET-CT scanner compared to standard of care pathology.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years. * Patient is confirmed with oral squamous cell carcinoma, soft tissue sarcoma or osteosarcoma. * Patient is indicated to undergo curative surgery of the primary tumor. * Patient is estimated compliant for study participation by the investigator. * Written informed consent. Exclusion Criteria: * Medical or psychiatric conditions that compromise the patient's ability to give informed consent; * Patient has previously received radiotherapy of the primary tumor region; * Patient has participated in other clinical studies with radiation exposure of more than 1 mSv in the past 12 months; * A blood glucose level over 200 mg/dL on the day of surgery. * Pregnancy or lactation.
References
Publications (0)
Data not yet available
No reference posted for this study.