Clinical trial · Interventional
Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region
Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region Using the Lara Device
NCT04266470CI-TRIAL-00057393withdrawnN/AClinicalTrials.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): Study is no longer feasible at our site.
Summary
Brief summary (as posted)
This study will investigate the ability of Lucerno Dynamics Lara sensor when placed on the palpable carotid artery (or femoral artery) to monitor blood flow following the injection of 18-FDG and to distinguish peak flow in tumor versus tissue uptake. Investigators will then assess if differences in tumor versus tissue correlates with tumor response.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lara Scan | Device | — | UNRESOLVED |
| PET/CT Scan - Pre-treatment and Post-treatment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lara Device Scan
- description
- This imaging study will be obtained strictly for the research purposes of mid-treatment assessment of blood flow and uptake kinetics analysis
- interventionNames
- Device: Lara Scan
- Diagnostic Test: PET/CT Scan - Pre-treatment and Post-treatment
Primary outcomes (1)
- measure
- Percentage of Tests That Input Function (IF) Could Be Calculated
- timeFrame
- At baseline
- description
- If input function can be calculated on five (5) or more (out of 10) patients, then investigators will consider this a feasible procedure. Input function is calculated using time-activity curves (TAC) from the arterial blood flow detector and integrating the signal over time. Peak and minimum values of each of the four (4) Lara detector time-activity curves (TAC) will be recorded to determine a range of expected values and if they are different.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Squamous cell carcinoma of the nasopharynx, oral cavity, oropharynx or hypopharynx with palpable adenopathy in the neck. Biopsy proven within the last 90 days. * Squamous cell carcinoma of the larynx regardless of lymph node status. Biopsy proven within the last 90 days. * Age 18 or greater. * Receiving definitive radiation therapy at Wake Forest University with or without concurrent systematic therapy. * Participants must be able to provide study specific informed consent prior to study entry. * Presence of metastatic disease is not an exclusion criteria provided subject will be receiving definitive doses of radiation to the local and regional disease. Exclusion Criteria * Cancers of the head and neck other than those stated above. This would include squamous cell carcinoma of unknown primary. * No measurable disease in the head and neck (ie planned adjuvant radiation therapy for allowable cancers with high risk pathology following definitive surgery). * Persons receiving less than curative doses of radiation. * Age under 18 * Unable or unwilling to tolerate PET/CT scan * Unable or unwilling to receive definitive treatment of their cancer at Wake Forest University * Pregnant women * Participants who present having already undergone a PET/CT will not be eligible for this study-because an important element of this trial is the assessment of 18-FDG uptake changes in response to treatment
References
Publications (0)
Data not yet available
No reference posted for this study.