Pilot Study of Coil Arrays in Patients With Advanced Solid Tumor Malignancies

A Pilot Study of Novel Magnetic Resonance Coil Arrays to Improve the Characterization of Liver Metastases in Patients With Advanced Solid Tumor Malignancies

This is a single center pilot study testing the use of novel coil arrays with MR liver imaging. In part A of the study, up to 30 healthy volunteers will be scanned, with iterative adjustment of coil array geometry and design to optimize imaging characterstics. In Part B of the study, 40 patients with advanced solid tumors and at least one liver metastasis measuring > 1.5 cm in diameter on standard anatomic scans will undergo MR liver imaging with the newly designed coil array, with the use of gadolinium contrast. Patients with liver tumors will have the option of undergoing a second MR liver scan during the course of subsequent systemic therapy.

Study Overview

• Status: Completed
• Conditions: Neoplams
• Intervention / Treatment: Procedure: MRI

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with Advanced Solid Tumor Malignancies

Description

Inclusion Criteria (Part B only - Patients with advanced solid tumor):

• Advanced solid tumor malignancy and the presence of at least one liver metastasis measuring > 1.5 cm in longest diameter in axial dimension on standard anatomic imaging

Exclusion Criteria (Part B only):

• Contra-indication to gadolinium contrast (e.g. chronic renal disease, prior allergic reaction) for patient studies

Exclusion Criteria (Part A [Healthy Volunteers] and Part B):

• Contra-indication to MRI (e.g. pacemaker, severe claustrophobia, suspected presence of MR-Unsafe surgical implants or shrapnel)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MRI; Day 1	Procedure: MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spatial Resolution	Adjust the coil array to optimize spatial resolution in healthy volunteers	Day 1
Scan coverage	Adjust the coil array to optimize scan coverage of the liver in healthy volunteers	Day 1
Mean contrast-to-noise ratio	Detectable using the coil array	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimum size of detectable metastatic lesion	Detected by MRI scan	Day 1
Degree signal	Detected by gandolinium contrast in MRI scan within liver metastases	Day 1
Time-to-peak signal	Detected by gandolinium contrast in MRI scan within liver metastases	Day 1

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2015
• Primary Completion (Actual): May 16, 2015
• Study Completion (Actual): May 16, 2015

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 10, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Advanced Solid Tumor
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 149516