Clinical trial · Observational
Can DW MRI Predict Outcome During Radiotherapy for Head and Neck Cancer?
Study of Diffusion Weighted MRI as a Predictive Biomarker of Response During Radiotherapy for High and Intermediate Risk Squamous Cell Cancer of the Oropharynx (MeRInO Study)
- 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)
Around 50% of patients with locally advanced H\&N cancer fail to achieve loco-regional control. Currently it cannot be predicted, during treatment, who will fall into this group of non-responders. This study is designed to assess the value of DW MRI as a predictive biomarker of response to radiotherapy in intermediate and high risk OPSCC.
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 |
|---|---|---|---|
| Diffuse Weighted MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- change in composite ADC
- timeFrame
- 3 weeks
- description
- Apparent Diffusion Coefficient measured at each MRI for each target lesion and the % change in each target lesion will be recorded at MRI2, in comparison with MRI1
- measure
- Relapse status
- timeFrame
- 18 months
- description
- Relapse status (control or failure), for each target lesion, will be recorded at the 18 month time point and compared with baseline. Control is defined as absence of any new mass, serial reduction in size or unchanged size of residual mass. Failure is defined as biopsy proven recurrence, new mass or serial increase in size of residual mass.
Secondary outcomes (1)
- measure
- Time to Relapse
- timeFrame
- Up to 22 Months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed HPV negative SCC oropharynx or patients with HPV positive SCC oropharynx and a significant smoking history * Stage III or Iva or IVb disease * Scheduled to undergo radical radiotherapy or chemo radiotherapy as primary treatment * 18 years of age or older * Able to give written informed consent * Patients willing and able to comply with the protocol for the duration of the study HPV status: As defined by the Scottish HPV reference laboratory, multiplex assay on Luminex technology Significant smoking history definition: greater than 10 pack years Exclusion Criteria: * Head and neck cancers from sub sites other than oropharynx * HPV+OPSCC in patients with no significant smoking history (low risk OPSCC) * Patients receiving cetuximab-radiotherapy * Confirmed distal metastatic disease (stage IVc) * Patients who have undergone primary surgery for SCC H\&N, neck dissection alone permitted * Patients who have received induction chemotherapy prior to definitive treatment * Patients with contra-indications to MRI scanning Contra-indications to MRI: As per standard diagnostic imaging protocol - cardiac pacemaker, surgery within 8 weeks, aneurysm clipped/treated, metal fragments in eye, previous cranial surgery, any metal in the body.
References
Publications (0)
Data not yet available