MRI-based radiomics to predict pathology response after neoadjuvant therapy in head and neck cancer
Official title: Application of MRI Radiomics Features in Neoadjuvant Therapy of Head and Neck Squamous Cell Carcinoma
Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT06755567 · Data updated 2026-11-12
This study tests whether MRI-derived radiomics features can predict which patients with head and neck squamous cell carcinoma will achieve a complete pathological response after neoadjuvant chemotherapy and PD-1–inhibitor therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 750 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | December 25, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2028 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT06755567 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with biopsy-proven head and neck squamous cell carcinoma, planned for two to three cycles of neoadjuvant chemoimmunotherapy, with an MRI within 30 days before therapy and planned radical surgery afterward.
✕Probably not a fit
Patients with distant metastases, prior head and neck treatment, significant MRI artifacts, or concurrent malignancies may not benefit from this predictive approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will analyze MRI radiomics combined with clinical data to identify patterns associated with pathological complete response (pCR) after neoadjuvant treatment in locally advanced head and neck squamous cell carcinoma. Participants have two to three cycles of neoadjuvant therapy (chemotherapy plus a PD-1 inhibitor) and undergo MRI within 30 days before starting therapy, followed by radical surgery. The aim is to develop a model that predicts pCR to guide individualized treatment decisions. Data will include MR imaging and complete clinical information and will focus on correlating imaging features with surgical pathology outcomes. The study is conducted at Sun Yat-Sen Memorial Hospital in Guangzhou, China.
Why it matters
Potential benefit: If successful, the model could help tailor neoadjuvant strategies and improve individualized treatment planning for head and neck cancer patients.
How similar studies have gone: Previous work in radiomics has shown promise for predicting treatment response in oncology, but this specific MRI radiomics–neoadjuvant setting for head and neck cancer is relatively novel and validation is ongoing.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * (a) patients pathologically diagnosed as head and neck squamous cell carcinoma; * (b) patients receiving two or three courses of neoadjuvant therapy (traditional chemotherapy plus PD-1 inhibitor); * (c) MR scan within 30 days before the first course of neoadjuvant therapy; * (d) patients undergoing radical surgical dissection following neoadjuvant therapy; * (e) complete clinical data available. Exclusion Criteria: * (a) previous head and neck treatment history; * (b) obvious motion or metal artifacts on the MRI image; * (c) distant metastasis; * (d) concurrent malignancies.
Where it's running
-
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Lin
- Email: linpliang3@mail.sysu.edu.cn
- Phone: 0086-020-34071439
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.