Applying PET/MR in Rectal Cancer.

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Diagnostic Test: PET/MR scan

• Registration Number: NCT04154124
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

The use of the novel recently introduced PET/MR scanner is believed to be promising in RC management, providing great anatomical details and detailed metabolic characterization. Preliminary data indicate it may become a strong imaging modality for staging of RC and has the potential to be used as a predictive tool guiding individualized therapy in patients receiving nT, but confirmation on prospective studies is mandatory. The use of radiomics as analysis approach may assist in achieving a better understanding of the obtained image data, and thus a more accurate disease assessment.

Objectives

1. To preliminary assess the potential diagnostic value of single PET/MR scan in RC staging and compare it to that of MRI alone, PET/CT alone, and combined MRI and PET/CT.

2. To preliminary assess the potential value of PET/MR in predicting pMR to nT.

3. To use radiomics analysis of PET/MR data to develop a quantification clinical tools that allow a more accurate and comprehensive assessment of RC patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-29
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-04
• Last Update Submitted: 2019-11-04
• Study First Posted: 2019-11-06
• Last Update Posted: 2019-11-06
• Study Start: 2019-11-23
• Primary Completion: 2020-12-23
• Study Completion: 2021-12-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Patients with newly diagnosed RC; histopathological confirmation of adenocarcinoma of colorectal origin.

Exclusion Criteria

1. Patients younger than 18 years;
2. pregnancy;
3. other known active malignancy;
4. previous chemotherapy or radiotherapy;
5. previous pelvic operation;
6. patient that no intent / not suited for neoadjuvant therapy (including metastatic disease at presentation); contraindication to intravenous contrast agents.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rectal Cancer Patients	PET/MR scan	-

Primary Outcome Measures

Name	Time	Method
Number of patient that shown the different between diagnostic value of single PET/MR scan in RC staging and compare it to that of MRI alone, PET/CT alone, and combined MRI and PET/CT	1 year