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NCT04159376 Clinical Trial

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

Bone Metastases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04159376
Other study ID # TASMC-19-ES-0574-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 25, 2019
Est. completion date December 25, 2021

Study information
Verified date November 2019
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date December 25, 2021
Est. primary completion date February 25, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• PET/MR
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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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