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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02390011
Other study ID # 149516
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
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