Clinical trial · Observational
Lymph Node Assessment Using Simultaneous 18F-FDG-PET and MRI
NCT02180308CI-TRIAL-00038152completedClinicalTrials.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 overarching goal of this study is to develop PET/MR techniques to accurately detect nodal metastases for surgical planning and assessment of treatment 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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PET/MRI
- description
- Patient receives PET/MRI
- interventionNames
- Device: PET/MRI
Primary outcomes (1)
- measure
- Accuracy of simultaneous FDG-PET/MRI for detection of nodal metastases
- timeFrame
- 2 years after beginning of study (July 2014 - June 2016)
- description
- This study is to assess PET/MR techniques for detection of nodal metastases for surgical planning and assessment of treatment response. Our central hypothesis is glucose metabolic rate (GMR) measured using a simultaneous PET/MR scanner can more accurately detect nodal metastases than standardized uptake value (SUV) measures from PET alone. SUV depends on both tumor metabolic rate and tracer delivery, which makes the interpretation of SUV challenging. For instance, an inflammatory node can have high SUV due to increased vascularity and vascular permeability and cannot be easily differentiated from a metastatic node, based on SUV. However, we hypothesize that inflammatory nodes will have lower GMR than metastatic nodes that contain highly proliferating cancer cells, such that they can be differentiated from metastatic nodes more reliably. This study will also determine if simultaneously acquired MRI can reduce uncertainty in GMR measurement of PET.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients with head and neck cancer who are scheduled for node dissection surgeries at NYU Langone Medical Center or Bellevue hospital are eligible. Exclusion Criteria: Normal MRI exclusion criteria will apply, including those on the following list. A standard MRI safety form will be used to identify potential conditions warranting exclusion. * Electrical implants such as cardiac pacemakers or perfusion pumps * Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants * Ferromagnetic objects such as jewelry or metal clips in clothing * Claustrophobia * History of seizures * Diabetes In addition, patients with GFR \< 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.
References
Publications (0)
Data not yet available
No reference posted for this study.