Clinical trial · Interventional
A Study of [F-18]HX4 (PET Imaging)Evaluated in Head and Neck Cancer Patients
A Phase I/II, Open Label, Nonrandomized, Multi-Center Study of [F-18]HX4 Positron Emission Tomography (PET) in Head and Neck Cancer Patients
NCT01506427CI-TRIAL-00008680withdrawnPhase 1 / Phase 2ClinicalTrials.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 purpose of this trial is to determine what will be the optimal imaging protocol for Head and Neck Cancer patients after \[F-18\] HX4 injection. This study will provide guidance for future studies involving \[F-18\]HX4 in cancer patients.
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 |
|---|---|---|---|
| [F-18] HX4 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [F-18] HX4
- interventionNames
- Radiation: [F-18] HX4
Primary outcomes (1)
- measure
- Serial measures of T/B Ratios and other imaging parameters
- timeFrame
- Approximately 1 month after patient imaging; comprehensive analysis will be concluded within 1 month after Last Patient Out
- description
- Serial measures of T/B ratios and other imaging parameters derived from the course imaging data of head and neck cancer pateitns in order to determine time of optimal imaging.
Secondary outcomes (3)
- measure
- Correlations between T/B ratios of [F-18]HX4 uptake from pre-surgery PET imaging and immunohistochemistry measurements
- timeFrame
- Estimated analysis to occur 1 month after patient surgery
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patient is \>18 years and male or female of any race / ethnicity. * Patient or patient's legally acceptable representative provides written inform consent Patient is willing and able to comply with protocol procedures. * Patient has newly diagnosed histologically confirmed squamous cell carcinoma of the head and/or neck whose primary origin is from the oral cavity, oropharynx, hypopharynx, larynx or nasopharynx. * Patient is scheduled to have or already has had a clinical \[F-18\]FDG PET/CT scan prior (recommended to be within 14 days prior) to the \[F-18\]HX4 PET/CT scan. * Patient has a primary tumor ≥ 2.0 cm in longest axis measured by CT or MR; or lymph node ≥ 2.0 cm in shortest axis measured by CT or MR if primary tumor \< 2 cm on CT or MR; CT may be part of required \[F-18\]FDG PET/CT scan or a separate pre-surgery CT scan. * Patient is scheduled to undergo complete tumor resection within 7 days for his/her cancer care after the \[F-18\]HX4 PET/CT scan is performed. * Patient has not had nor will have neoadjuvant treatment, including radiation and chemotherapy, prior to patient's planned tumor resection. Exclusion Criteria: * Female patient is pregnant or nursing. * Patient is not capable of remaining still for duration of imaging procedure (\~ 4 hours). * Patient has undergone an investigative, radioactive research procedure within 7 days prior to study participation, or is scheduled to undergo such a procedure during the study participation period. * Patient has chronic renal function failure or is on renal dialysis * Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data.
References
Publications (0)
Data not yet available
No reference posted for this study.