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NCT03401814 Clinical Trial

Imaging Response to Immunotherapy and Radiation Therapy in Patients With Liver Metastases

Liver Metastases Clinical Trial

Official title:
Imaging Response to Immunotherapy and Radiation Therapy in Patients With Liver Metastases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03401814
Other study ID # 17-009021
Secondary ID ROR1721
Status Completed
Phase
First received
Last updated
Start date August 2, 2018
Est. completion date December 12, 2019

Study information
Verified date July 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date December 12, 2019
Est. primary completion date December 12, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Contraindications for MRI including claustrophobia, pace maker, metal implants, aneurism clips - Patients who are not able to consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Magnetic Resonance Elastography
rapidly developing technology for quantitatively assessing the mechanical properties of tissue, using externally applied mechanical waves

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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