Clinical trial · Observational
Detection of Cervical Lymph Node Metastases With a High-Resolution Positron Emission Tomography (PET) Imaging System
Feasibility Study for Detection of Cervical Lymph Node Metastases With a High-Resolution PET Imaging System in Patients With Known or Suspected Cancers of the Upper Aerodigestive Tract
- 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 goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for PET scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine PET/CT. Researchers will compare the images taken using the PEMFlex Solo II to the images taken during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s), magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of peripheral tumor lesions identified in standard PET/CT imaging also identifiable in PEM images.
- timeFrame
- 20 minutes for imaging using PEMFlex Solo II, within ± 30 days of standard PET/CT imaging
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. A signed informed consent. 2. Known or suspected primary cancer of the upper aerodigestive tract, which may be determined by biopsy, physical examination- including upper endoscopy or noninvasive imaging studies including CT, MR, ultrasound, or prior PET. 3. Known or suspected metastatic disease to cervical lymph nodes based on physical examination, imaging studies or biopsy. 4. Scheduled for routine clinical imaging at the ACB PET/CT facility. 5. Participant must be at least 18 years of age. Exclusion Criteria: 1. Prior treatment (chemotherapy, radiotherapy) for cancer of the upper aerodigestive tract. 2. Prior biopsy procedures, including resection of the primary cancer, will not exclude the patient from participation. 3. Uncontrolled blood glucose levels (\>200 mg/dl). 4. Patient is unable to comprehend the requirements of the study. 5. Patient is unable to undergo scanning of the neck with the PEM (PET) scanner (due to body habitus, inability to comply with positioning requirements, etc.).
References
Publications (0)
Data not yet available