완전히 통합된 PET/MRI를 사용한 GEJ 암에 대한 nCRT에 대한 반응 평가 (Escape)
완전히 통합된 PET/MRI를 이용한 식도 및 위식도 접합부 암(GEJ)에 대한 선행 화학-방사선 요법(nCRT)에 대한 반응 평가 예측
Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).
연구 개요
상세 설명
This is a prospective, observational single center study which plans to enroll patients with biopsy proven potentially resectable esophageal or junctional cancer scheduled to receive nCRT (CROSS regimen) prior to surgery.
The study aims to evaluate Routine pre-treatment work-up includes PET to stage the tumour extension.
- PET/MRI (Magnetic resonance imaging) will replace the PET component of CT(computed tomography)
- An additional intermediate 18-FDG (Fluorodeoxyglucose) PET/MRI will be performed during nCRT
- Post nCRT imaging, as required prior to surgery, will be PET/MRI six weeks after treatment completion.
- 8-12 weeks post nCRT completion surgery will be performed, based on each patient's performance status and response to nCRT
- Histopathological samples of the excised tumor and lymph nodes will be used for diagnosis, staging and description of qualitative and quantitative parameters Routine clinical and radiological follow-up for 24 months (for the scope of this study) will follow the standard clinical workflow assigned to this group of patients.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Milan, 이탈리아, 20132
- Deaprtment of Radiology, IRCCS Ospedale San Raffaele
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- biopsy-proven esophageal or junctional carcinomas (either adenocarcinoma (AC) or squamous cell carcinoma (SCC) for which an Ivor-Lewis transthoracic esophagectomy with supramesocolic and mediastinal lymphadenectomy is indicated;
- visible tumor on pre-treatment imaging;
- ≥ 18 years of age;
- signed informed consent.
Exclusion Criteria:
- - incomplete preoperative imaging assessment;
- contraindications to neoadjuvant treatment;
- contraindications to preoperative imaging (such as pacemaker, allergy to contrast agents);
- inability to complete imaging examinations (i.e. severe claustrophobia);
- contraindication to surgery (comorbidities, distant metastatic disease (imaging confirmed));
- pregnant or lactating women
- severe hypersensitivity to gadobutrol or fludeoxyglucose F18.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: Hybrid PET/MRI
For the purposes of the study, in addition to standard imaging (EUS and CT scan), a fully integrated hybrid PET/MRI (PET/MRI) study with FDG will replace the Standard PET (pre-surgical evaluation) used for evaluating distant metastases and will be considered as the add-on procedure at three time points. The additional evaluation for patients is that during nCRT treatment. |
An additional intermediate 18-FDG PET/MRI will be performed during neoadjuvant chemo-radiation therapy. Routine pre-treatment work-up PET/MRI will replace PET alone. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Response to neoadjuvant treatment -MRI
기간: 0-36 months
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MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints |
0-36 months
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Response to neoadjuvant treatment -PET
기간: 0-36 months
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PET component -quantitative evaluation and delta between timepoints |
0-36 months
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Response to neoadjuvant treatment - Histology
기간: 0-36 months
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Evaluate degree of tumor regression after neoadjuvant therapy according to the Mandard Tumour regression grade ; integrated Immunohistochemistry |
0-36 months
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Response to neoadjuvant treatment -Radiomics
기간: 0-36 months
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Radiomic features extracted from hybrid imaging |
0-36 months
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Imaging parameters as potential predictors of tumor response
기간: 0- 48 months
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Select imaging parameters that can be considered potential predictors of the responder/non-responder status assessment |
0- 48 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Early regression model (ERI)
기간: 0- 60 months
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Evaluate the ERI model as a predictor of histological response (TRG grade) based on MRI tumor volume assessment |
0- 60 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Francesco De Cobelli, MD, IRCCS Ospedale San Raffaele
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
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