NCT03528200

Brief Summary

This is a prospective pilot study evaluating the efficacy of DynaCT in direct comparison to conventional catheter angiography in demonstrating the anatomic details of the vessels supplying brain lesions. Forty patients will be recruited for this pilot study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 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

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2015

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

5.6 years

First QC Date

October 1, 2015

Last Update Submit

January 29, 2021

Conditions

Brain Lesions

Outcome Measures

Primary Outcomes (2)

  • CBV Comparison

    Compare a baseline IV Dyna CBV pre-embolization and immediate post embolization CBV to assess quality of vascular embolization.

    One week

  • Correlation of CBV

    Correlate changes in CBV (post embolization to pre-embolization, and CBV in patients who did not get embolization) to improved surgical procedure (ease of resection, surgical blood loss).

    One week

Study Arms (1)

Dyna Embo

OTHER

Contrast dye injected through the IV in their arm which helps to see the blood in the arteries using x-ray pictures

Other: Contrast

Interventions

ContrastOTHER

The scan requires that the patient lie still on a hard surface for about 5-10 minutes. Before the scan, they will have a special fluid called contrast dye injected through the IV in their arm. This contrast dye helps to see the blood in the arteries using x-ray pictures. After the IV dyna CBV is completed, they will have their routine conventional angiography to evaluate the lesion for embolizable arteries as part of routine clinical care. If the patient undergoes embolization of the lesion (as part of the standard of care), a post embolization Dyna CBV will be performed.

Also known as: iodinated contrast
Dyna Embo

Eligibility Criteria

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

You may qualify if:

  • \. Patients scheduled to have an intracranial lesion evaluated for possible surgical resection.

You may not qualify if:

  • Patients with severe contrast allergies
  • Women who are pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

Contrast Media

Intervention Hierarchy (Ancestors)

Diagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Design

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

Study Record Dates

First Submitted

October 1, 2015

First Posted

May 17, 2018

Study Start

July 1, 2015

Primary Completion

January 22, 2021

Study Completion

January 22, 2021

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

US(1)