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

NCT06854107 | Completed DMC

• 2 other identifiers: [2024]KYLL(SO4)no. 2025HBCHHHRC006
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pathologic Complete Response

Keywords

Oral squamous cell carcinoma; Radiomics; Intratumoral and peritumoral; Habitat imaging; Pathologic complete response

Outcome Measures

Primary Outcomes (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.

  From 2024 to 2025

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study comprehensively reviewed the clinical information of OSCC patients who underwent NACI at two institutions from March 2020 to December 2023.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zilong Yuan: lead
• Hubei Cancer Hospital: collaborator

Study Sites (1)

Hubei Cancer Hospitla

Wuhan, Hubei, 430000, China

Location

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MeSH Terms

Conditions

Pathologic Complete Response; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: December 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

CN (1)