Assessment of the Accuracy of PET/MR in Detection and Monitoring Response of Bone Metastases
1 other identifier
interventional
150
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
November 12, 2019
CompletedStudy Start
First participant enrolled
December 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2021
CompletedNovember 12, 2019
November 1, 2019
2 months
October 29, 2019
November 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 year
Study Arms (1)
Bone Metastases Patients
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- patients having metastatic skeletal involvement on baseline PET/CT prior to treatment
You may not qualify if:
- Age \<18.
- Pregnant or breast feeding patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2019
First Posted
November 12, 2019
Study Start
December 25, 2019
Primary Completion
February 25, 2020
Study Completion
December 25, 2021
Last Updated
November 12, 2019
Record last verified: 2019-11