Clinical trial · Interventional
FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer
A Multicenter Trial of FDG-PET/CT Staging of Head and Neck Cancer and Its Impact on the N0 Neck Surgical Treatment in Head and Neck Cancer Patients
- 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)
RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET/CT scan, may help doctors find head and neck cancer and find out how far the disease has spread. It may also help doctors plan the best treatment. PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing the tumor and planning neck surgery in patients with newly diagnosed head and neck cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FDG PET/CT
- description
- Planning for Therapeutic conventional surgery of the N0 neck is documented prior to and immediately after review of the fludeoxyglucose F 18 (FDG)-PET/CT scan completed per protocol.
- interventionNames
- Procedure: therapeutic conventional surgery
- Radiation: fludeoxyglucose F 18
Primary outcomes (1)
- measure
- Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes
- timeFrame
- Within Two Weeks Before Surgery and after sampling of neck lymph nodes
- description
- True negative cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise.
Secondary outcomes (13)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed newly diagnosed squamous cell carcinoma (SCC) of the head and neck , including any of the following sites:
* Oral cavity
* Oropharynx, including base of tongue and tonsils
* Larynx
* Supraglottis
* Stage T2-T4, N0-N3 disease
* Unilateral or bilateral neck dissection planned
* No N2c disease (if bilateral disease is present)
* Has ≥ 1 clinically N0 neck side as defined by clinical exam (physical exam with CT scan and/or MRI)
* A N0 neck must be planned to be dissected for the patient to be eligible
* . The N0 neck can be either ipsilateral to the head and neck tumor or the contralateral N0 neck if a bilateral neck dissection is planned
* CT scan and/or MRI taken within the past 4 weeks to confirm SCC of the head and neck
* Simultaneous diagnostic CT with PET scan allowed; however, PET cannot be used as part of the criteria to define the N0 neck disease
* For CT scan and/or MR images from other institutions, ACRIN recommends a re-read by a local neuro-radiologist to ensure compliance
* No sinonasal cancer, salivary gland cancer, thyroid cancer, nasopharyngeal cancer, or advanced skin cancer
PATIENT CHARACTERISTICS:
* Not pregnant or nursing
* Negative pregnancy test
* Weight ≤ 350 lbs
* No poorly controlled diabetes (defined as fasting glucose level \> 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications (optimally, patients will have glucose \< 150 mg/dL)
* No underlying medical condition that would preclude surgery (neck dissection)
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (1)
- RESULTLowe VJ, Duan F, Subramaniam RM, Sicks JD, Romanoff J, Bartel T, Yu JQM, Nussenbaum B, Richmon J, Arnold CD, Cognetti D, Stack BC Jr. Multicenter Trial of [18F]fluorodeoxyglucose Positron Emission Tomography/Computed Tomography Staging of Head and Neck Cancer and Negative Predictive Value and Surgical Impact in the N0 Neck: Results From ACRIN 6685. J Clin Oncol. 2019 Jul 10;37(20):1704-1712. doi: 10.1200/JCO.18.01182. Epub 2019 Feb 15. PMID 30768363