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18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes

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ClinicalTrials.gov Identifier: NCT03095313
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel S. Berman, Cedars-Sinai Medical Center

Brief Summary:

This is a pilot study in which we will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters.

Additionally, the data will serve as preliminary data to plan a larger study to investigate study objectives.


Condition or disease Intervention/treatment Phase
Aortic Stenosis Other: 18F-NaF Phase 2

Detailed Description:

This five-year pilot study will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters. Techniques that can identify specific increases in calcification activity are therefore likely to provide important insights into predicting the longevity of TAVR valves and guidance towards subsequent interventions.

Twenty patients whom have undergone either TAVR or surgical bioprosthetic aortic valve replacement will be invited to participate in an 18F-NaF PET scan (baseline) and CT scan imaging (baseline and Year 2). Baseline, Year 1 and 2 will also include clinical assessment, labs and echocardiograms. Telephone contact at Years 3, 4, and 5 will provide follow up for major cardiovascular adverse events.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: 18-F Sodium Fluoride (18F-NaF) Positron Emission Tomography (PET) for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
Actual Study Start Date : May 23, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Experimental: 18F-NaF PET and CT scanning
18F-NaF PET-CT scan (at Baseline visit only) Contrast-enhanced CT Scan (at Baseline and Year 2 only) with possible beta-blocker and nitroglycerin, if medically safe.
Other: 18F-NaF

At baseline a target dose of 125 MBq 18F-NaF will be administered intravenously to all subjects who will then undergo dual cardiac and respiratory-gated PET-CT imaging of the heart and aortic valve. 125ml of iodine-based contrast agent (iohexol [Omnipaque™]) will be given for the CT. Nitroglycerin will be given to increase the size of the coronary arteries and a possible dose of metoprolol may be given to control target heart rate.

Repeat contrast-enhanced CT of the heart and aortic valve will be conducted at Year 2 to investigate to investigate whether 18F-NaF activity predicts progression of calcification in prosthetic valves.

Other Names:
  • 18F Sodium Flouride
  • sodium flouride PET




Primary Outcome Measures :
  1. Presence of calcification activity within the replacement valve by 18F-NaF PET-CT [ Time Frame: Baseline ]
    Presence of calcification activity will be determined by presence of uptake of the radiotracer, 18F-NaF, on 18F-NaF PET-CT images.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged ≥60 years
  • Patients between 1 month and 5 years following transcatheter aortic valve replacement (TAVR) or surgical bioprosthetic aortic valve replacement

Exclusion Criteria:

  • Inability to provide informed consent
  • Creatinine >1.5 mg/dL
  • History of severe allergy to iodine contrast agents
  • Active atrial fibrillation
  • Paget's disease
  • Metastatic malignancy

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): NCT03095313


Contacts
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Contact: Daniel S. Berman, MD 310 423-4223 bermand@cshs.org
Contact: Rhona Littman 310 423-4387 littmanr@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Daniel S Berman, MD    310-423-4223    bermand@cshs.org   
Principal Investigator: Daniel S Berman, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Daniel S. Berman, MD Cedars-Sinai Medical Center

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Responsible Party: Daniel S. Berman, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03095313     History of Changes
Other Study ID Numbers: 46429
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Daniel S. Berman, Cedars-Sinai Medical Center:
Transcatheter Aortic Valve Replacement (TAVR).
Surgical bioprosthetic aortic valve replacement

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents