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Completed

NCT Number: NCT02390011

Pilot Study of Coil Arrays 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.

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Key information

Conditions

Neoplams

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MRI

Procedure

Primary outcomes

  1. Spatial Resolution

    Time frame: Day 1

    Adjust the coil array to optimize spatial resolution in healthy volunteers

  2. Scan coverage

    Time frame: Day 1

    Adjust the coil array to optimize scan coverage of the liver in healthy volunteers

  3. Mean contrast-to-noise ratio

    Time frame: Day 1

    Detectable using the coil array

Secondary outcomes

  1. Minimum size of detectable metastatic lesion

    Time frame: Day 1

    Detected by MRI scan

  2. Degree signal

    Time frame: Day 1

    Detected by gandolinium contrast in MRI scan within liver metastases

  3. Time-to-peak signal

    Time frame: Day 1

    Detected by gandolinium contrast in MRI scan within liver metastases

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2015
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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