NCT04870645

Brief Summary

This clinical trial studies the different types of investigational imaging techniques called sequences during magnetic resonance imaging (MRI) of the head before and after radiation therapy in patients with cancer that has spread to the brain (intracranial metastases). This clinical trial also compares these new techniques with standard MRI imaging to see if sequences provide better images. Diagnostic procedures, such as MRI, may help find and diagnose solid organ cancer and find out how far the disease has spread.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

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

March 30, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 22, 2024

Completed
Last Updated

November 6, 2024

Status Verified

September 1, 2024

Enrollment Period

2.4 years

First QC Date

April 26, 2021

Results QC Date

August 30, 2024

Last Update Submit

October 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Contrast to Noise Ratio

    Contrast enhancement compared to baseline and normalized to background noise

    Participants enrolled in the study were followed for variable amounts of times (up to 2 years and 4 months) from the date of their enrollment and baseline imaging

Study Arms (1)

Diagnostic (advanced MRI)

EXPERIMENTAL

Patients undergo conventional and advanced MRI over 60 minutes within 14 days before the start of scheduled brain radiation treatment. Patients then undergo 7 additional MRI over 60 minutes each between 4-16 weeks apart. Patients may receive gadolinium and/or iopamidol during MRI scans.

Procedure: Advanced Magnetic Resonance ImagingProcedure: Conventional Magnetic Resonance ImagingDrug: Gadolinium-ChelateDrug: Iopamidol

Interventions

Undergo advanced MRI

Also known as: AMRI
Diagnostic (advanced MRI)

Undergo conventional MRI

Also known as: Conventional MRI
Diagnostic (advanced MRI)

Contrast agent

Also known as: Gadolinium Coordination Complex, Gadolinium-based Contrast Agent, Gadolinium-Chelant Complex
Diagnostic (advanced MRI)

Contrast agent

Also known as: Isovue, Niopam, Solutrast
Diagnostic (advanced MRI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An adult patient with pathology-proven solid organ cancer
  • MRI of the brain with contrast, positive for at least one intra-axial metastatic lesion greater than 5 mm
  • Planned treatment with stereotactic radiation

You may not qualify if:

  • Contraindication to MR imaging
  • Known allergy to gadolinium-based contrast agents
  • Renal failure as defined by a glomerular filtration rate (GFR) less than 30 or the use of hemodialysis
  • Pregnant
  • Patients less than 18 years of age will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Iopamidol

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Jason Johnson, MD
Organization
M D Anderson Cancer Center

Study Officials

  • Jason M Johnson

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 3, 2021

Study Start

March 30, 2021

Primary Completion

August 29, 2023

Study Completion

August 29, 2023

Last Updated

November 6, 2024

Results First Posted

October 22, 2024

Record last verified: 2024-09

Locations