Clinical trial · Observational
Repeatability and Reproducibility of the ADC Map in Head and Neck Cancer. Prospective Multicenter Study
NCT06749301CI-TRIAL-00113809ADC/SCC osscompletedClinicalTrials.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)
Evaluation of the repeatability and reproducibility of ADC maps in both primary and non-primary lesions lymph nodes in patients with head and neck cancer, using an acquisition protocol Standardized DWI
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 Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients with primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity c
- description
- Patients over 18 years of age with primary squamous cell carcinoma of the head and neck (hypopharynx, oropharynx or oral cavity, confirmed by histology) will be prospectively enrolled and, according to standard procedures, will have to undergo an MRI examination for diagnostic purposes.
Primary outcomes (1)
- measure
- Evaluation of the short-term repeatability of ADC maps in both primary and nodal lesions in patients with squamous cell carcinomas (SCC) of the head and neck
- timeFrame
- 18 months
- description
- A standardized and shared DWI acquisition protocol will be used at a multicenter level. DWI imaging consists of a spin-echo echo-planar (SE-EPI) sequence that will be acquired with 1.5 T or 3 T tomographs, setting the acquisition parameters, after the administration of the contrast medium (if any) (in order to ensure that the second DWI acquisition is performed under the same conditions as the first). The MRI study must include at least one T2-weighted axial sequence, whose images will be used to support the delineation of the lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age over 18 years; * primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity; confirmed by histology; * a lesion visible on at least three consecutive DWI images, with a minimum diameter of 2 cm; * specific written informed consent; Exclusion Criteria: * incomplete acquisition of DWI images; * presence of artifacts that do not allow quantitative analysis of DWI images; * performance status 2 or more according to Zubrod.
References
Publications (0)
Data not yet available
No reference posted for this study.