Clinical trial · Interventional
PET/CT: Role in Detecting Unknown Primary Head and Neck Cancer
The Clinical Utility of PET-CT in the Management of Squamous Cell Carcinoma of Neck Nodes With an Unknown Primary Malignancy.
- 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)
Historically metastatic squamous cell carcinoma in a cervical lymph node from an occult primary malignancy of the head and neck was evaluated with panendoscopy and biopsies of high risk areas, such as the base of tongue, nasopharynx, and tonsils. This diagnostic protocol identifies the primary malignancy in about 50% of cases. In recent years, the availability of CT has slightly increased the detection rate to 65% when used as an adjunct to the traditional work-up. Studies using PET as an adjunct are conflicting with detection rates ranging up to 75%. Currently, no prospective study has analyzed the role of the PET-CT fusion in the work-up of an occult primary malignancy of the head and neck. This study will compare the detection rate of the traditional work-up to a new protocol involving a pre-operative diagnostic PET-CT.
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/CT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- All patients have PET/CT and biopsies with the surgeon blinded to the result of PET/CT. Additional biopsies are performed (or not) after the surgeon has the PET/CT results revealed.
- interventionNames
- Other: PET/CT
Primary outcomes (1)
- measure
- proportion of patients where PET/CT resulted in a change in diagnosis
- timeFrame
- 2 weeks after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years old * Biopsy proven SCC in a cervical lymph node * Unknown primary cancer after: History, Physical exam, and office endoscopy by otolaryngologist * Negative Chest X-Ray for malignancy * Patient consent signed to undergo investigative protocol Exclusion Criteria: * Un-fit for general anesthesia * Unable to lie flat for 45 minutes * Unable to fast for \> 6 hours * Unable to perform PET-CT (Obesity \> 150kg) * Pregnant * Prior Head and Neck cancer * Any invasive cancer (Non-Head and Neck) within the last 2 years
References
Publications (0)
Data not yet available