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

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.

Study Overview

• Status: Unknown
• Conditions: Bone Metastases
• Intervention / Treatment: Diagnostic test: PET/MR

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bone Metastases Patients

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): December 25, 2019
• Primary Completion (Anticipated): February 25, 2020
• Study Completion (Anticipated): December 25, 2021

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Hematologic Diseases; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
• Other Study ID Numbers: TASMC-19-ES-0574-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No