- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07857317
Non-Contrast Versus Contrast-Enhanced MRI in Colorectal Liver Metastases
Comparative Evaluation of a Non-Contrast Abbreviated MRI Protocol and a Contrast-Enhanced MRI Protocol in Colorectal Liver Metastases
This prospective study aims to compare the diagnostic performance of a non-contrast abbreviated MRI protocol with a contrast-enhanced MRI protocol for the detection and follow-up assessment of colorectal liver metastases.
연구 개요
상세 설명
Accurate detection and follow-up of colorectal liver metastases are essential for staging and treatment planning. This observational study will include patients with histologically confirmed colorectal adenocarcinoma and suspected hepatic metastases.
Each participant will undergo a non-contrast abbreviated MRI protocol followed by a contrast-enhanced MRI protocol using Gadodiamide during the same examination. Contrast-enhanced MSCT of the abdomen will serve as the reference standard. Treatment response will be assessed according to RECIST 1.1 on follow-up MRI.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Mina M William, Resident
- 전화번호: 01273242181
- 이메일: mina.18313293@med.aun.edu.eg
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients with histologically confirmed colorectal adenocarcinoma and suspected hepatic metastases referred to the Diagnostic and Interventional Radiology Department at Assiut University Hospitals.
설명
Inclusion Criteria:
- - Histologically confirmed colorectal adenocarcinoma
- One or more hepatic focal lesions known or suspected to represent colorectal liver metastases
- Adequate image quality allowing reliable assessment of hepatic lesions
- Patients scheduled to receive chemotherapy allowing assessment of treatment response
- Patients referred for initial staging, restaging, or evaluation of treatment response
- Written informed consent
Exclusion Criteria:
- - Contraindications to gadolinium-based contrast administration
- Incomplete MRI examinations
- Inadequate image quality preventing reliable assessment
- Contraindications to MRI examination
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
|
Single cohort: Patients with Colorectal Liver Metastases
Patients with confirmed colorectal adenocarcinoma and suspected hepatic metastases who will undergo both non-contrast and contrast-enhanced MRI protocols during the same examination. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Sensitivity of non-contrast MRI for detection of hepatic metastases
기간: Baseline
|
Sensitivity of the non-contrast abbreviated MRI protocol for detection of hepatic metastases, using contrast-enhanced MSCT as the reference standard. |
Baseline
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Sensitivity of contrast-enhanced MRI for detection of hepatic metastases
기간: Baseline
|
Sensitivity of the contrast-enhanced MRI protocol for detection of hepatic metastases, using contrast-enhanced MSCT as the reference standard. |
Baseline
|
|
Specificity of non-contrast MRI
기간: Baseline
|
Specificity of the non-contrast abbreviated MRI protocol for detection of hepatic metastases. |
Baseline
|
|
Specificity of contrast-enhanced MRI
기간: Baseline
|
Specificity of the contrast-enhanced MRI protocol for detection of hepatic metastases. |
Baseline
|
|
Number of hepatic lesions detected by non-contrast MRI
기간: Baseline
|
Mean number of hepatic metastatic lesions detected by the non-contrast MRI protocol. |
Baseline
|
|
Number of hepatic lesions detected by contrast-enhanced MRI
기간: Baseline
|
Mean number of hepatic metastatic lesions detected by the contrast-enhanced MRI protocol. |
Baseline
|
|
Proportion of patients with partial response according to RECIST 1.1
기간: At 3 months
|
Proportion of patients classified as partial response according to RECIST 1.1 on follow-up MRI. |
At 3 months
|
공동 작업자 및 조사자
수사관
- 연구 의자: Amr F Mourad, prof, Diagnostic and Interventional Radiology Department, Assiut University Hospitals
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .