NCT02390011

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2015

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

March 4, 2015

Last Update Submit

March 7, 2022

Conditions

Neoplams

Keywords

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Minimum size of detectable metastatic lesion

    Day 1

  • Degree signal

    Day 1

  • Time-to-peak signal

    Day 1

Study Arms (1)

MRI

Day 1

Procedure: MRI

Interventions

MRIPROCEDURE
MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Advanced Solid Tumor Malignancies

You may qualify if:

  • 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

You may not qualify if:

  • Contra-indication to gadolinium contrast (e.g. chronic renal disease, prior allergic reaction) for patient studies
  • Contra-indication to MRI (e.g. pacemaker, severe claustrophobia, suspected presence of MR-Unsafe surgical implants or shrapnel)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Study Officials

  • Rahul Aggarwal, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 17, 2015

Study Start

January 8, 2015

Primary Completion

May 16, 2015

Study Completion

May 16, 2015

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

US(1)