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

Neoplams Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390011
• Other study ID #: 149516
• Status: Completed
• Start date: January 8, 2015
• Est. completion date: May 16, 2015

Study information

• Verified date: March 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 16, 2015
• Est. primary completion date: May 16, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neoplams
• Neoplasms

Intervention

Procedure:
• MRI

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spatial Resolution	Adjust the coil array to optimize spatial resolution in healthy volunteers	Day 1
Primary	Scan coverage	Adjust the coil array to optimize scan coverage of the liver in healthy volunteers	Day 1
Primary	Mean contrast-to-noise ratio	Detectable using the coil array	Day 1
Secondary	Minimum size of detectable metastatic lesion	Detected by MRI scan	Day 1
Secondary	Degree signal	Detected by gandolinium contrast in MRI scan within liver metastases	Day 1
Secondary	Time-to-peak signal	Detected by gandolinium contrast in MRI scan within liver metastases	Day 1