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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Mina M William, Resident
- 電話番号：01273242181
- メール：mina.18313293@med.aun.edu.eg
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients with histologically confirmed colorectal adenocarcinoma and suspected hepatic metastases referred to the Diagnostic and Interventional Radiology Department at Assiut University Hospitals.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_ONLY
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sensitivity of non-contrast MRI for detection of hepatic metastases
時間枠：Baseline
|
Sensitivity of the non-contrast abbreviated MRI protocol for detection of hepatic metastases, using contrast-enhanced MSCT as the reference standard. |
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sensitivity of contrast-enhanced MRI for detection of hepatic metastases
時間枠：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
時間枠：Baseline
|
Specificity of the non-contrast abbreviated MRI protocol for detection of hepatic metastases. |
Baseline
|
|
Specificity of contrast-enhanced MRI
時間枠：Baseline
|
Specificity of the contrast-enhanced MRI protocol for detection of hepatic metastases. |
Baseline
|
|
Number of hepatic lesions detected by non-contrast MRI
時間枠：Baseline
|
Mean number of hepatic metastatic lesions detected by the non-contrast MRI protocol. |
Baseline
|
|
Number of hepatic lesions detected by contrast-enhanced MRI
時間枠：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
時間枠：At 3 months
|
Proportion of patients classified as partial response according to RECIST 1.1 on follow-up MRI. |
At 3 months
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Amr F Mourad, prof、Diagnostic and Interventional Radiology Department, Assiut University Hospitals
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。