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
About this trial
This is an interventional diagnostic trial for Bone Metastases
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.
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
NCT ID
NCT04159376
First Posted
October 29, 2019
Last Updated
November 7, 2019
Sponsor
Tel-Aviv Sourasky Medical Center
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
Learn more about this trial
Assessment of the Accuracy of PET/MR in Detection and Monitoring Response of Bone Metastases
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