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DYNA EMBOLIZATION - Pilot Study of IV Dyna CT and CBV Imaging Techniques (DynaEmbo)

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ClinicalTrials.gov Identifier: NCT03528200
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Brain Lesions Other: Contrast Not Applicable

Detailed Description:

There are common intracranial lesions that have increased vascularity that makes surgical resection difficult. Embolization can improve the surgical procedure by easing the resection, decreasing blood loss during surgical resection, and improving visibility of the surgical bed during resection. Conventional intra-arterial (IA) angiography is the gold standard to evaluating pathologies for embolization candidates, however the invasiveness of the procedure (with associated risks), time requirements, and resource utilization of evaluating and possibly embolization of these patients are precluding its widespread use.

Devising a test methodology that is quick, with less risk, and can accurately detect arteries that are of value in embolizing these pathologies will improve the utilization as a screening tool and will result in improved resource utilization that focuses only on those patients that require embolization. Lastly, by correlating the Dyna CBV to surgical resection quality (ease of resection, blood loss from surgical site), a non-invasive, controlled method to evaluating embolization quality can be established to aid surgeons in pre-operative planning as well as serve as a method of evaluating embolization materials designed for the blood vessels associated with brain lesions.

The DynaCT technique is a fully FDA-approved application of the Siemens imaging system and software. DynaCT is often performed during our angiographic and interventional procedures. Neurointerventionists have begun to apply this technology within their practices, and the investigators have selectively applied DynaCT for various clinical applications. However, at this point the investigators have not incorporated the technology into clinical care for patients with intracranial lesions.

Although DynaCT is an approved technology, there have been recent improvements in the software performing the 3D reconstruction. These new features will be used in this study and thus the investigators consider them to be "research scans."

Study patients will provide informed consent for the scan and the patients will not be billed for the DynaCT portion of the procedure (only the standard of care conventional angiography). The investigators have specifically chosen to image patients already undergoing conventional angiography for surgical resection in order to have a direct comparison.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of IV Dyna CT and CBV Imaging Techniques in Preparation for Vascular Embolization Procedures - DYNA EMBOLIZATION
Study Start Date : July 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Dyna Embo
Contrast dye injected through the IV in their arm which helps to see the blood in the arteries using x-ray pictures
Other: Contrast

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.

Other Name: iodinated contrast




Primary Outcome Measures :
  1. CBV Comparison [ Time Frame: One week ]
    Compare a baseline IV Dyna CBV pre-embolization and immediate post embolization CBV to assess quality of vascular embolization.

  2. Correlation of CBV [ Time Frame: One week ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528200


Contacts
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Contact: Teena Wyatt 843-792-9226 wyattt@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Melza vanRoijen    843-792-1679    vanroije@musc.edu   
Principal Investigator: Raymond Turner, MD         
Sponsors and Collaborators
Medical University of South Carolina
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03528200    
Other Study ID Numbers: PRO00043620
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020