search
Back to results

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
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectal Cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    October 29, 2019
    Last Updated
    November 4, 2019
    Sponsor
    Tel-Aviv Sourasky Medical Center
    search

    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

    Learn more about this trial

    Applying PET/MR in Rectal Cancer.

    We'll reach out to this number within 24 hrs