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MRI 'Fingerprint' may reveal which head and neck tumors vanish with Pre-Surgery therapy

NCT ID NCT06755567

Diagnosis Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This study tests whether a computer model that analyzes MRI images can predict which patients with head and neck cancer will have a complete response to neoadjuvant therapy, which combines chemotherapy and immunotherapy before surgery. Researchers will build the model using MRI scans and clinical data from 750 patients who receive two or three cycles of this therapy followed by surgery. The goal is to accurately identify patients who achieve a pathological complete response, meaning no cancer remains in the removed tissue, to help guide individualized treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MRI-based radiomics-clinical model
What this could lead to
If the model works, doctors could tailor neoadjuvant therapy for head and neck cancer, sparing non-responders from ineffective treatment and guiding them to surgery sooner.
What could go wrong
The model is experimental and may not predict accurately across all patients. MRI features can vary by scanner and technique, so results may not generalize widely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 750 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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) .

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma Pathologic Complete Response

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chemotherapy Head and neck cancer Immunotherapy Neoadjuvant therapy Pathologic complete response

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Sun Yat-sen Memorial Hospital

    RECRUITING

    Guangzhou, Guangdong, 510000, China

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