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

NCT ID: NCT04159376

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-25
• Study Completion Date: 2021-12-25

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.

Conditions

Bone Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Bone Metastases Patients

Group Type: EXPERIMENTAL

PET/MR

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TASMC-19-ES-0574-CTIL

Identifier Type: -

Identifier Source: org_study_id