- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06854107
MRI의 종양 내 및 복막 서식지 방사선 MRI는 경구 편평 세포 암종에서 신 보조 화학 면역 요법에 대한 병리학 적 완전한 반응을 예측합니다.
배경 : Neoadjuvant Chemoimmunotherapy (NACI)는 구강 편평 세포 암종 (OSCC)에서 약속을 보여 주지만 병리학 적 완전 반응 (PCR)을 예측하기위한 신뢰할 수있는 비 침습적 바이오 마커는 희소합니다. 다중 시퀀스 MRI에 걸친 종양 내 및 복막 이질성을 통합하는 방사선은 치료 반응 평가에 대한 새로운 통찰력을 제공 할 수 있습니다.
방법 : NACI 후 OSCC를 가진 212 명의 환자의 데이터를 후 향적으로 수집하고 분석 하였다. 이 환자들 중에서, 56 명 (26.4%)은 NACI 후 PCR을 달성했다. T1- 가중 이미징 (T1WI), 지방 억제 (T2WI)를 사용한 축 방향 T2 가중 이미징 및 대조 강화 T1- 가중 이미징 (T1C)에 적용되는 K-Leans 클러스터링 알고리즘을 사용하여 종양 내 및 복막 및 복막 서식지 영상화 (HI)를 달성 하였다. 또한, 종양 내 및 복막 HI 모델을 수신기 작동 특성 (ROC) 곡선을 사용하여 구성하고 비교 하였다. 모델과 착용감을 완화하기 위해 5 배 교차 검증을 수행 하였다.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Hubei
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Wuhan, Hubei, 중국, 430000
- Hubei Cancer Hospitla
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
포함 기준 : (a) 초기 진단에서 조직 병리학 적으로 확인 된 OSCC; (b) 첫 번째 MRI 검사 전에받은 치료 없음; (c) NACI의 수령; (d) NACI 후 MRI 검사를 받았다; (e) 외과 적 개입이 발생했습니다.
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배제 기준 :- (a) 임상 데이터의 부재 및 수술 후 병리학 적 결과; (b) MRI 이미지 아티팩트는 이미지 품질에 크게 영향을 미칩니다.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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MRI의 종양 내 및 복막 서식지 방사성 방사선 MRI의 방사선은 경구 편평 세포 암종에서 신 보조 화학 면역 요법에 대한 병리학 적 완전한 반응을 예측합니다.
기간: 2024 년부터 2025 년까지
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다중 시퀀스 MRI로부터 유래 된 통합 된 종양 내 및 복막 HI는 OSCC 환자에서 NACI에 따라 PCR에 대한 높은 예측 능력을 제공한다.
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2024 년부터 2025 년까지
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
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연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- [2024]KYLL(SO4)
- no. 2025HBCHHHRC006 (기타 보조금/기금 번호: Yuan Wu)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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