AzTrials
AzTrials

Pathologic Complete ResponseNCT06854107

Intratumoral and Peritumoral Habitat Radiomics of MRI Predict Pathologic Complete Response to Neoadjuvant Chemoimmunotherapy in Oral Squamous Cell Carcinoma

An observational study of Pathologic Complete Response, run by Zilong Yuan at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background：Neoadjuvant chemoimmunotherapy (NACI) shows promise in oral squamous cell carcinoma (OSCC), but reliable noninvasive biomarkers for predicting pathologic complete response (pCR) remain scarce. Read more about this study

Who is it for?
Any age
Conditions the study is for
Pathologic Complete Response
How many people
225 participants
Where
1 siteChina
Study dates
1 Dec 2023to 1 Dec 2023
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: This study comprehensively reviewed the clinical information of OSCC patients who underwent NACI at two institutions from March 2020 to December 2023.

Who may be able to join

  • Histopathologically confirmed OSCC at the initial diagnosis;
  • No treatment received prior to the first MRI examination;
  • Receipt of NACI;
  • Underwent MRI examination after NACI;
  • Underwent surgical intervention.

Who cannot join

  • Absence of clinical data and postoperative pathological results;
  • MRI image artifacts significantly affecting image quality.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hubei Cancer Hospitla

    Wuhan, Hubei, 430000

Other trials in China

About this study

Background：Neoadjuvant chemoimmunotherapy (NACI) shows promise in oral squamous cell carcinoma (OSCC), but reliable noninvasive biomarkers for predicting pathologic complete response (pCR) remain scarce. Radiomics integrating intratumoral and peritumoral heterogeneity across multi-sequence MRI may offer novel insights into treatment response evaluation.

Methods: The data of 212 patients with OSCC after NACI were retrospectively collected and analyzed. Among these patients, 56 (26.4%) achieved pCR after NACI. Intratumoral and peritumoral habitat imaging (HI) was achieved using the K-means clustering algorithm applied to T1-weighted imaging (T1WI), axial T2-weighted imaging with fat suppression (T2WI), and contrast-enhanced T1-weighted imaging with fat suppression (T1C). Moreover, intratumoral and peritumoral HI models were constructed and compared using the receiver operating characteristic (ROC) curve. Five-fold cross-validation was performed to mitigate model overfitting.

Keywords
Oral squamous cell carcinoma, Radiomics, Intratumoral and peritumoral, Habitat imaging, Pathologic complete response
Medical subject headings
Pathologic Complete Response, Squamous Cell Carcinoma of Head and Neck

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intratumoral and Peritumoral Habitat Radiomics of MRI predicts pathologic complete response to neoadjuvant chemoimmunotherapy in oral squamous cell carcinoma

    Integrated intratumoral and peritumoral HI derived from multi-sequence MRI offers a high predictive capacity for pCR following NACI in OSCC patients.

    Measured: From 2024 to 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2025
  2. Study start1 Dec 2023
  3. Primary completion1 Dec 2023
  4. Study completion1 Dec 2023

Resources

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
Other
Time perspective
Retrospective
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06854107
Sponsor's protocol ID
[2024]KYLL(SO4)
Other IDs
no. 2025HBCHHHRC006
Status last verified
Mar 2025
First submitted
25 Feb 2025
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Vaidya P, Bera K, Patil PD, Gupta A, Jain P, Alilou M, Khorrami M, Velcheti V, Madabhushi A. Novel, non-invasive imaging approach to identify patients with advanced non-small cell lung cancer at risk of hyperprogressive disease with immune checkpoint blockade. J Immunother Cancer. 2020 Oct;8(2):e001343. doi: 10.1136/jitc-2020-001343.

    PubMed 33051342

  • Tunali I, Hall LO, Napel S, Cherezov D, Guvenis A, Gillies RJ, Schabath MB. Stability and reproducibility of computed tomography radiomic features extracted from peritumoral regions of lung cancer lesions. Med Phys. 2019 Nov;46(11):5075-5085. doi: 10.1002/mp.13808. Epub 2019 Sep 23.

    PubMed 31494946

  • Wang CY, Ginat DT. Preliminary Computed Tomography Radiomics Model for Predicting Pretreatment CD8+ T-Cell Infiltration Status for Primary Head and Neck Squamous Cell Carcinoma. J Comput Assist Tomogr. 2021 Jul-Aug 01;45(4):629-636. doi: 10.1097/RCT.0000000000001149.

    PubMed 34519454

  • Wang C, Wu F, Wang F, Chong HH, Sun H, Huang P, Xiao Y, Yang C, Zeng M. The Association Between Tumor Radiomic Analysis and Peritumor Habitat-Derived Radiomic Analysis on Gadoxetate Disodium-Enhanced MRI With Microvascular Invasion in Hepatocellular Carcinoma. J Magn Reson Imaging. 2025 Mar;61(3):1428-1439. doi: 10.1002/jmri.29523. Epub 2024 Jul 12.

    PubMed 38997242

  • Shang Y, Chen W, Li G, Huang Y, Wang Y, Kui X, Li M, Zheng H, Zhao W, Liu J. Computed Tomography-derived intratumoral and peritumoral radiomics in predicting EGFR mutation in lung adenocarcinoma. Radiol Med. 2023 Dec;128(12):1483-1496. doi: 10.1007/s11547-023-01722-6. Epub 2023 Sep 25.

    PubMed 37749461

  • Shang Y, Zeng Y, Luo S, Wang Y, Yao J, Li M, Li X, Kui X, Wu H, Fan K, Li ZC, Zheng H, Li G, Liu J, Zhao W. Habitat Imaging With Tumoral and Peritumoral Radiomics for Prediction of Lung Adenocarcinoma Invasiveness on Preoperative Chest CT: A Multicenter Study. AJR Am J Roentgenol. 2024 Oct;223(4):e2431675. doi: 10.2214/AJR.24.31675. Epub 2024 Aug 14.

    PubMed 39140631

  • Jiang Y, Wang H, Wu J, Chen C, Yuan Q, Huang W, Li T, Xi S, Hu Y, Zhou Z, Xu Y, Li G, Li R. Noninvasive imaging evaluation of tumor immune microenvironment to predict outcomes in gastric cancer. Ann Oncol. 2020 Jun;31(6):760-768. doi: 10.1016/j.annonc.2020.03.295. Epub 2020 Mar 30.

    PubMed 32240794

  • Braman N, Prasanna P, Whitney J, Singh S, Beig N, Etesami M, Bates DDB, Gallagher K, Bloch BN, Vulchi M, Turk P, Bera K, Abraham J, Sikov WM, Somlo G, Harris LN, Gilmore H, Plecha D, Varadan V, Madabhushi A. Association of Peritumoral Radiomics With Tumor Biology and Pathologic Response to Preoperative Targeted Therapy for HER2 (ERBB2)-Positive Breast Cancer. JAMA Netw Open. 2019 Apr 5;2(4):e192561. doi: 10.1001/jamanetworkopen.2019.2561.

    PubMed 31002322

  • Wu J, Cao G, Sun X, Lee J, Rubin DL, Napel S, Kurian AW, Daniel BL, Li R. Intratumoral Spatial Heterogeneity at Perfusion MR Imaging Predicts Recurrence-free Survival in Locally Advanced Breast Cancer Treated with Neoadjuvant Chemotherapy. Radiology. 2018 Jul;288(1):26-35. doi: 10.1148/radiol.2018172462. Epub 2018 May 1.

    PubMed 29714680

  • Xie C, Yang P, Zhang X, Xu L, Wang X, Li X, Zhang L, Xie R, Yang L, Jing Z, Zhang H, Ding L, Kuang Y, Niu T, Wu S. Sub-region based radiomics analysis for survival prediction in oesophageal tumours treated by definitive concurrent chemoradiotherapy. EBioMedicine. 2019 Jun;44:289-297. doi: 10.1016/j.ebiom.2019.05.023. Epub 2019 May 23.

    PubMed 31129097

  • Wu J, Gensheimer MF, Zhang N, Guo M, Liang R, Zhang C, Fischbein N, Pollom EL, Beadle B, Le QT, Li R. Tumor Subregion Evolution-Based Imaging Features to Assess Early Response and Predict Prognosis in Oropharyngeal Cancer. J Nucl Med. 2020 Mar;61(3):327-336. doi: 10.2967/jnumed.119.230037. Epub 2019 Aug 16.

    PubMed 31420498

  • Kim M, Park JE, Yoon SK, Kim N, Kim YH, Kim JH, Kim HS. Vessel size and perfusion-derived vascular habitat refines prediction of treatment failure to bevacizumab in recurrent glioblastomas: validation in a prospective cohort. Eur Radiol. 2023 Jun;33(6):4475-4485. doi: 10.1007/s00330-022-09164-w. Epub 2022 Oct 15.

    PubMed 36242633

  • Lee DH, Park JE, Kim N, Park SY, Kim YH, Cho YH, Kim JH, Kim HS. Tumor Habitat Analysis Using Longitudinal Physiological MRI to Predict Tumor Recurrence After Stereotactic Radiosurgery for Brain Metastasis. Korean J Radiol. 2023 Mar;24(3):235-246. doi: 10.3348/kjr.2022.0492. Epub 2023 Feb 6.

    PubMed 36788768

  • Ling X, Alexander GS, Molitoris J, Choi J, Schumaker L, Mehra R, Gaykalova DA, Ren L. Identification of CT-based non-invasive radiomic biomarkers for overall survival prediction in oral cavity squamous cell carcinoma. Sci Rep. 2023 Dec 8;13(1):21774. doi: 10.1038/s41598-023-48048-x.

    PubMed 38066047

  • Ozturk EMA, Unsal G, Erisir F, Orhan K. Prediction of bone invasion of oral squamous cell carcinoma using a magnetic resonance imaging-based machine learning model. Eur Arch Otorhinolaryngol. 2024 Dec;281(12):6585-6597. doi: 10.1007/s00405-024-08862-z. Epub 2024 Jul 31.

    PubMed 39083062

Questions about this trial

What is this clinical trial studying?

An observational study of Pathologic Complete Response, run by Zilong Yuan 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 2 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: finished, as of the sponsor's last update on 6 Mar 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intratumoral and Peritumoral Habitat Radiomics of MRI predicts pathologic complete response to neoadjuvant chemoimmunotherapy in oral squamous cell carcinoma (time frame: From 2024 to 2025). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06854107, which also lists 35 linked publications.

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 6 Mar 2025.

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