Head and Neck CancerNCT06755567
Application of MRI Radiomics Features in Neoadjuvant Therapy of Head and Neck Squamous Cell Carcinoma
An observational study of Head and Neck Cancer and Neoadjuvant Therapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Neoadjuvant therapy, including neoadjuvant chemotherapy and immunotherapy, is recommended for patients with locally advanced head and neck cancer. The response to neoadjuvant therapy varies among the patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer, Neoadjuvant Therapy, Immunotherapy
- What is being tested?
- MRI-based radiomics-clinical model
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with head and neck squamous cell carcinoma, who were treated in Sun Yat-sen Memorial Hospital between January 2020 and October 2023, were included and randomly allocated into a training set (n = 300) and an internal validation set (n = 150). Patients treated in Sun Yat-Sen University Cancer Centre, Shenshan Medical Centre, Memorial Hospital of Sun Yat-sen University and Huizhou First Hospital between January 2020 and April 2024, were assigned as an external validation set (n = 150) . Patients treated in Sun Yat-sen Memorial Hospital, Sun Yat-Sen University Cancer Centre, Shenshan Medical Centre, Memorial Hospital of Sun Yat-sen University and Huizhou First Hospital between October 2024 and June 2025, were assigned as an prospective validation set (n = 150) .
Who may be able to join
- (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.
Who cannot join
- (a) previous head and neck treatment history;
- (b) obvious motion or metal artifacts on the MRI image;
- (c) distant metastasis;
- (d) concurrent malignancies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510000
Lin, 008602034071439, linpliang3@mail.sysu.edu.cn
About this study
Head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Neoadjuvant therapy, including neoadjuvant chemotherapy and immunotherapy, is recommended for patients with locally advanced head and neck cancer. The response to neoadjuvant therapy varies among the patients. It is reported that about 37% of the patients achieve pathological complete response after receiving neoadjuvant therapy, who would achieve a better prognosis compared with the patients with non-pathological complete response. It is significant to predict and assess response to neoadjuvant therapy for the patients with head and neck cancer accurately, which could assist in formulating individualized therapeutic regimens. MRI has good soft tissue resolution and is a common preoperative examination method. However, this method lacks the ability to accurately predict the probability of patients achieving pathological remission after neoadjuvant therapy. At present, it is a novel and effective method to construct a model to predict the efficacy of neoadjuvant therapy based on MRI image omics analysis, and certain achievements have been made in breast cancer and rectal cancer. In this study, multi-sequence MRI was combined with clinical risk factors to construct an imaging omics model to predict the probability of pathological complete remission of patients with head and neck squamous cell carcinoma after neoadjuvant therapy, and to accurately identify diagnostic imaging remission, so as to better assist clinical decision-making.
- Conditions
- Head and Neck Cancer, Neoadjuvant Therapy, Immunotherapy, Chemotherapy, Pathologic Complete Response
- Being tested
- MRI-based radiomics-clinical model
- Medical subject headings
- Head and Neck Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-based radiomics-clinical modelDiagnostic test
Response to NACI was predicted using MRI-based radiomics-clinical model.
| Study group | Role | What they receive |
|---|---|---|
| HNSCC with NACI | HNSCC with neoadjuvant chemoimmunotherapy, following by radical sugery. Receives: Diagnostic Test: MRI-based radiomics-clinical model |
What is being measured
The primary outcome is the main question the study is designed to answer.
the area under the receiver operating characteristic (AUROC) curves
Measured: 2021.1-2023.2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start25 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755567
- Sponsor's protocol ID
- SYSKY-2023-1175-02
- Status last verified
- May 2026
- First submitted
- 24 Dec 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of MRI Radiomics Features in Neoadjuvant Therapy of Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06755567
- Acronym / sponsor ID
- SYSKY-2023-1175-02
- Conditions
- Head and Neck Cancer, Neoadjuvant Therapy, Immunotherapy, Chemotherapy, Pathologic Complete Response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Neoadjuvant therapy, including neoadjuvant chemotherapy and immunotherapy, is recommended for patients with locally advanced head and neck cancer. The response to neoadjuvant therapy varies among the patients. It is reported that about 37% of the patients achieve pathological complete response after receiving neoadjuvant therapy, who would achieve a better prognosis compared with the patients with non-pathological complete response. It is significant to predict and assess response to neoadjuvant therapy for the patients with head and neck cancer accurately, which could assist in formulating individualized therapeutic regimens. MRI has good soft tissue resolution and is a common preoperative examination method. However, this method lacks the ability to accurately predict the probability of patients achieving pathological remission after neoadjuvant therapy. At present, it is a novel and effective method to construct a model to predict the efficacy of neoadjuvant therapy based on MRI image omics analysis, and certain achievements have been made in breast cancer and rectal cancer. In this study, multi-sequence MRI was combined with clinical risk factors to construct an imaging omics model to predict the probability of pathological complete remission of patients with head and neck squamous cell carcinoma after neoadjuvant therapy, and to accurately identify diagnostic imaging remission, so as to better assist clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HNSCC with NACI | – | Diagnostic Test: MRI-based radiomics-clinical modelHNSCC with neoadjuvant chemoimmunotherapy, following by radical sugery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with head and neck squamous cell carcinoma, who were treated in Sun Yat-sen Memorial Hospital between January 2020 and October 2023, were included and randomly allocated into a training set (n = 300) and an internal validation set (n = 150). Patients treated in Sun Yat-Sen University Cancer Centre, Shenshan Medical Centre, Memorial Hospital of Sun Yat-sen University and Huizhou First Hospital between January 2020 and April 2024, were assigned as an external validation set (n = 150) . Patients treated in Sun Yat-sen Memorial Hospital, Sun Yat-Sen University Cancer Centre, Shenshan Medical Centre, Memorial Hospital of Sun Yat-sen University and Huizhou First Hospital between October 2024 and June 2025, were assigned as an prospective validation set (n = 150) .
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (4 listed)
- (a) previous head and neck treatment history;
- (b) obvious motion or metal artifacts on the MRI image;
- (c) distant metastasis;
- (d) concurrent malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI-based radiomics-clinical modelResponse to NACI was predicted using MRI-based radiomics-clinical model. | Diagnostic test | HNSCC with NACI |
Primary outcome
the area under the receiver operating characteristic (AUROC) curves
Time frame: 2021.1-2023.2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Neoadjuvant Therapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin (0086-020-34071439, linpliang3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the area under the receiver operating characteristic (AUROC) curves (time frame: 2021.1-2023.2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.