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Assessment of the Accuracy of PET/MR in Detection and Monitoring Response of Bone Metastases

Primary Purpose

Bone Metastases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET/MR
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bone Metastases

Eligibility Criteria

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

Inclusion Criteria:

150 patients having metastatic skeletal involvement on baseline PET/CT prior to treatment

Exclusion Criteria:

  1. Age <18.
  2. Pregnant or breast feeding patients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Bone Metastases Patients

    Arm Description

    Outcomes

    Primary Outcome Measures

    The investigators will report about the number of patients who preformed PET/MR for assessment of skeletal involvement as well as activity after treatment,
    and also preformed in routine PET/CT and to optimize the algorithm of MR-based attenuated PET images.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 29, 2019
    Last Updated
    November 7, 2019
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04159376
    Brief Title
    Assessment of the Accuracy of PET/MR in Detection and Monitoring Response of Bone Metastases
    Official Title
    Assessment of the Accuracy of PET/MR in Detection and Monitoring Response of Bone Metastases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 25, 2019 (Anticipated)
    Primary Completion Date
    February 25, 2020 (Anticipated)
    Study Completion Date
    December 25, 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 great promise of PET/MR for assessment of skeletal metastatic involvement is derived from the extensive experience with stand- alone MR, but initial data on the use of PET/MR for assessment of bone pathology indicate that PET/MR introduces unique issues that should be addressed when determining its role in this clinical scenario. In this study cohort includes 150 patients 18 years or older, having metastatic skeletal involvement on baseline PET/CT prior to treatment. Baseline studies and follow up studies of the patients referred post treatment, will be reviewed. The main goal of the study is to asses the accuracy of PET/MR in detection and monitoring response of bone metastases.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Metastases

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bone Metastases Patients
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    PET/MR
    Intervention Description
    All patients will have a PET/CT and PET/MR study performed at the same clinical setting using a single dose of tracer administration. The study cohort includes 150 patients 18 years or older, having metastatic skeletal involvement on baseline PET/CT prior to treatment. Baseline studies and follow up studies of the patients referred post treatment, will be reviewed. The tracers will be FDG, labelled PSMA labelled Somatostatin and F-DOPA in order to assess skeletal lesions detection of all tumor types. Skeletal lesions will be divided into marrow-based lesions, lytic, blastic and scleroric lesions. Tracer uptake will be measured at baseline and after treatment. Metabolic PET parameters, CT appearance and MR parameters will be assessed. The best MR-based attenuation algorithm for detection of lesions and monitoring response will be derived.
    Primary Outcome Measure Information:
    Title
    The investigators will report about the number of patients who preformed PET/MR for assessment of skeletal involvement as well as activity after treatment,
    Description
    and also preformed in routine PET/CT and to optimize the algorithm of MR-based attenuated PET images.
    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: 150 patients having metastatic skeletal involvement on baseline PET/CT prior to treatment Exclusion Criteria: Age <18. Pregnant or breast feeding patients.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Assessment of the Accuracy of PET/MR in Detection and Monitoring Response of Bone Metastases

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