Applying PET/MR in Rectal Cancer.
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET/MR scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Rectal Cancer
Eligibility Criteria
Inclusion Criteria:
1.Patients with newly diagnosed RC; histopathological confirmation of adenocarcinoma of colorectal origin.
Exclusion Criteria:
- Patients younger than 18 years;
- pregnancy;
- other known active malignancy;
- previous chemotherapy or radiotherapy;
- previous pelvic operation;
- patient that no intent / not suited for neoadjuvant therapy (including metastatic disease at presentation); contraindication to intravenous contrast agents.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rectal Cancer Patients
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04154124
First Posted
October 29, 2019
Last Updated
November 4, 2019
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04154124
Brief Title
Applying PET/MR in Rectal Cancer.
Official Title
Applying PET/MR in Rectal Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 23, 2019 (Anticipated)
Primary Completion Date
December 23, 2020 (Anticipated)
Study Completion Date
December 23, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
To preliminary assess the potential value of PET/MR in predicting pMR to nT.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rectal Cancer Patients
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/MR scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Patients with newly diagnosed RC; histopathological confirmation of adenocarcinoma of colorectal origin.
Exclusion Criteria:
Patients younger than 18 years;
pregnancy;
other known active malignancy;
previous chemotherapy or radiotherapy;
previous pelvic operation;
patient that no intent / not suited for neoadjuvant therapy (including metastatic disease at presentation); contraindication to intravenous contrast agents.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Applying PET/MR in Rectal Cancer.
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