Applying PET/MR in Rectal Cancer.

NCT ID: NCT04154124

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-23
• Study Completion Date: 2021-12-23

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Rectal Cancer Patients

Group Type: EXPERIMENTAL

PET/MR scan

Intervention Type: DIAGNOSTIC_TEST

whole-body PET/CT scan and pelvic PET/MR scan (MR protocol will include three plane fast spin echo T2 weighted, DWI and dynamic contrast enhanced imaging). The ad interim assessment will use a pelvic PET/MR scan only (without PET/CT), to avoid the radiation associated with whole body CT. In the staging and post-nT assessment, the addition of PET/MR to the standard use of PET/CT adds no radiation exposure.

Interventions

PET/MR scan

whole-body PET/CT scan and pelvic PET/MR scan (MR protocol will include three plane fast spin echo T2 weighted, DWI and dynamic contrast enhanced imaging). The ad interim assessment will use a pelvic PET/MR scan only (without PET/CT), to avoid the radiation associated with whole body CT. In the staging and post-nT assessment, the addition of PET/MR to the standard use of PET/CT adds no radiation exposure.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TASMC-19-ES-0448-CTIL

Identifier Type: -

Identifier Source: org_study_id