Clinical trial · Interventional
Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT
NCT04685798CI-TRIAL-00080601terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
The investigators propose a longitudinal study evaluating post-treatment changes in patients with squamous cell carcinoma (SCC) of the neck using an innovative optimized diffusion-weighted imaging (DWI) pulse sequence to identify more accurately recurrent tumors as well as early non-responders to therapy.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diffusion-weighted imaging magnetic resonance imaging | Device | — | UNRESOLVED |
| FDG PET/CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DWI MRI + Standard of care FDG PET/CT
- description
- -The patients will undergo an optimized research neck DWI MRI, up to 3 weeks post-treatment and then a standard-of-care 3-month post-treatment FDG PET/CT examination.
- interventionNames
- Device: Diffusion-weighted imaging magnetic resonance imaging
- Device: FDG PET/CT
Primary outcomes (2)
- measure
- Apparent Diffusion Coefficient Mean (ADCmean)
- timeFrame
- 2-3 weeks post-standard of care treatment
- description
- * ADC=measure of the magnitude of diffusion (of water molecules) within tissue * The primary tumor, suspicious lesion, and/or area of post-treatment change will be identified in anatomical images \& then outlined in the ADC sequence, excluding areas of cystic change and necrosis. If there are multiple lesions, only the dominant lesion with the lowest ADC will be used for analysis * A histogram analysis method will examine the distribution of ADC values within each region of interest (ROI) * ADCmean will describe distribution of ADC measurements in tumor/non-tumor tissues \& independent sample t-test will compare ADC measurements between the 2 groups
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-proven newly diagnosis or recurrence as indicated by tissue diagnosis of T3 or T4 squamous cell carcinoma of the head and neck * Must have had or be scheduled for standard-of-care surgical resection, radiation, and/or chemo-radiation of the diagnosed squamous cell carcinoma of the head and neck * At least 18 years of age * Patient must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: * Contraindications to MRI, including: * MRI-incompatible implantable devices * severe claustrophobia; and * Pregnant and/or breastfeeding, with women of childbearing potential having a negative urine or serum pregnancy test
References
Publications (0)
Data not yet available
No reference posted for this study.