Head and Neck Squamous Cell CarcinomaNCT05964595
Temporal Diffusion Spectroscopy MRI in Predicting the CPS of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy
An observational study of Head and Neck Squamous Cell Carcinoma and Magnetic Resonance Imaging, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The goal of this observational study is to explore the application of temporal diffusion spectroscopy MRI in head and neck squamous cell carcinoma (HNSCC). The main questions it aims to answer are: If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the comprehensive positive score (CPS)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Magnetic Resonance Imaging, Neoadjuvant Therapy
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients first diagnosed with HNSCC by pathological biopsy and proposed to receive preoperative neoadjuvant therapy at Sun Yat-sen Memorial Hospital
Who may be able to join
- Patients first diagnosed with head and neck squamous cell carcinoma (HNSCC) by pathological biopsy
- Patients proposed to receive 2-3 courses of neoadjuvant chemotherapy and immunotherapy
- Patients without contraindications for MRI, such as nonremovable ferromagnetic metal foreign body, claustrophobia, renal insufficiency, and previous history of gadolinium contrast allergy
Who cannot join
- Less than 10mm in the maximum diameter of the baseline primary tumor
- Poor MRI image quality with obvious metal or motion artifacts
- The failure to complete the course of neoadjuvant therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510000
Xiaohui Duan, Prof., 13512762365, duanxh5@mail.sysu.edu.cn
About this study
Official title: Temporal Diffusion Spectroscopy MRI in Predicting the Comprehensive Positive Score of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy in Head and Neck Squamous Cell Carcinoma
The goal of this observational study is to explore the application of temporal diffusion spectroscopy MRI in head and neck squamous cell carcinoma (HNSCC).
The main questions it aims to answer are:
Read more
- If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the comprehensive positive score (CPS) of pathological PD-L1 expression in HNSCC?
- If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the efficacy of neoadjuvant therapy in HNSCC? Participants will receive head and neck MRI, including T2WI, T1WI, diffusion-weighted imaging (DWI), oscillating gradient spin echo (OGSE) and pulsed gradient spin echo (PGSE) sequence before and after neoadjuvant therapy.
There is not a comparison group in our study.
- Keywords
- Head and neck squamous cell Carcinoma, Temporal diffusion spectroscopy imaging, Programmed death-ligand 1, Neoadjuvant therapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive positive score
Comprehensive positive score for PD-L1 expression
Measured: 1 week before neoadjuvant therapy
Pathological response
Postoperative pathological tumor residual status
Measured: 1 month after the last neoadjuvant therapy
Change from maximum transverse tumor diameter after neoadjuvant therapy
Maximum transverse tumor diameter before and after neoadjuvant therapy
Measured: 1 week before the first neoadjuvant therapy and 1 month after the last neoadjuvant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (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 Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 136 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964595
- Sponsor's protocol ID
- SYSKY-2023-498-01
- Status last verified
- Jul 2023
- First submitted
- 21 Jun 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Diffusion Spectroscopy MRI in Predicting the Comprehensive Positive Score of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy in Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05964595
- Acronym / sponsor ID
- SYSKY-2023-498-01
- Keywords
- Head and neck squamous cell Carcinoma, Temporal diffusion spectroscopy imaging, Programmed death-ligand 1, Neoadjuvant therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jul 2023 (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.
The goal of this observational study is to explore the application of temporal diffusion spectroscopy MRI in head and neck squamous cell carcinoma (HNSCC).
The main questions it aims to answer are:
- If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the comprehensive positive score (CPS) of pathological PD-L1 expression in HNSCC?
- If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the efficacy of neoadjuvant therapy in HNSCC? Participants will receive head and neck MRI, including T2WI, T1WI, diffusion-weighted imaging (DWI), oscillating gradient spin echo (OGSE) and pulsed gradient spin echo (PGSE) sequence before and after neoadjuvant therapy.
There is not a comparison group in our study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients first diagnosed with HNSCC by pathological biopsy and proposed to receive preoperative neoadjuvant therapy at Sun Yat-sen Memorial Hospital
Key inclusion criteria (3 listed)
- Patients first diagnosed with head and neck squamous cell carcinoma (HNSCC) by pathological biopsy
- Patients proposed to receive 2-3 courses of neoadjuvant chemotherapy and immunotherapy
- Patients without contraindications for MRI, such as nonremovable ferromagnetic metal foreign body, claustrophobia, renal insufficiency, and previous history of gadolinium contrast allergy
Key exclusion criteria (3 listed)
- Less than 10mm in the maximum diameter of the baseline primary tumor
- Poor MRI image quality with obvious metal or motion artifacts
- The failure to complete the course of neoadjuvant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comprehensive positive score
Time frame: 1 week before neoadjuvant therapy
Comprehensive positive score for PD-L1 expression
Pathological response
Time frame: 1 month after the last neoadjuvant therapy
Postoperative pathological tumor residual status
Change from maximum transverse tumor diameter after neoadjuvant therapy
Time frame: 1 week before the first neoadjuvant therapy and 1 month after the last neoadjuvant therapy
Maximum transverse tumor diameter before and after neoadjuvant therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Squamous Cell Carcinoma and Magnetic Resonance Imaging, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohui Duan, Prof. (13512762365, duanxh5@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive positive score (time frame: 1 week before neoadjuvant therapy). The study lists 3 primary outcomes in all. 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 28 Jul 2023.