NCT03401814

Brief Summary

Patients will be imaged with MRE at the time of the RT planning MRI, prior to the induction of RT and immunotherapy. Research imaging will be in addition to standard imaging studies performed at time points consistent with the standard of care (at the time of the RT planning MRI and the first clinical follow-up). An additional MRE exam will be performed at the end of treatment outside the standard of care imaging.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

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

First Submitted

Initial submission to the registry

January 10, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

August 2, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
Last Updated

July 9, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

January 10, 2018

Last Update Submit

July 8, 2021

Conditions

Liver Metastases

Outcome Measures

Primary Outcomes (1)

  • Quantify tissue mechanical properties of the liver and liver tumor using MRE in patients receiving radiation therapy + immunotherapy at baseline, mid-treatment and time of followup imaging determined by standard of care to assess response to therapy

    1 year

Interventions

Magnetic Resonance ElastographyOTHER

rapidly developing technology for quantitatively assessing the mechanical properties of tissue, using externally applied mechanical waves

Also known as: MRE

Eligibility Criteria

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

Radiation patients with liver metastases

You may qualify if:

  • Age ≥ 18 years
  • Diagnosis of solid cancers with the presence of one or more liver metastases
  • Minimum metastasis diameter ≥ 2 cm
  • Planning to receive radiation therapy with immunotherapy
  • Willingness to participate in mandatory imaging studies at Mayo Clinic Rochester

You may not qualify if:

  • Contraindications for MRI including claustrophobia, pace maker, metal implants, aneurism clips
  • Patients who are not able to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Sean Park, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncology Consultant

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 17, 2018

Study Start

August 2, 2018

Primary Completion

December 12, 2019

Study Completion

December 12, 2019

Last Updated

July 9, 2021

Record last verified: 2021-07

Locations

US(1)