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Trial record 8 of 96 for:    avid

Flortaucipir 18F PET Imaging in BIOCARD Study

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Avid Radiopharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT03052972
First received: February 10, 2017
Last updated: April 13, 2017
Last verified: April 2017
  Purpose
This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals (BIOCARD) study at Johns Hopkins University.

Condition Intervention Phase
Cognitive Decline Drug: 18F-AV-1451 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Flortaucipir (18F) PET Imaging in the BIOCARD Study

Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Evaluate Flortaucipir uptake as measured by SUVr by amyloid status from subjects in BIOCARD [ Time Frame: 75 minutes post dose administration ]
    All 18F-AV-1451 PET images obtained after 75 minutes of injection will be analyzed.


Estimated Enrollment: 100
Actual Study Start Date: March 23, 2017
Estimated Study Completion Date: January 31, 2018
Estimated Primary Completion Date: January 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amyloid Positive
Clinically normal amyloid positive subjects from BIOCARD study will receive 370 MBq (10 mCi) 18F-AV-1451
Drug: 18F-AV-1451
Subjects will receive single IV administration of 370 megabecquerel (MBq)(10 millicurie [mCi]) of 18FAV- 1451.
Other Names:
  • Flortaucipir F18
  • [F-18]T807
Experimental: Amyloid Negative
Clinically normal amyloid negative subjects from BIOCARD study will receive 370 MBq (10 mCi) 18F-AV-1451
Drug: 18F-AV-1451
Subjects will receive single IV administration of 370 megabecquerel (MBq)(10 millicurie [mCi]) of 18FAV- 1451.
Other Names:
  • Flortaucipir F18
  • [F-18]T807

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or females that have provided consent and are currently enrolled in BIOCARD study
  • Ability to tolerate PET scan procedures
  • Ability to provide informed consent for study procedures

Exclusion Criteria:

  • Has condition(s) that could augment risk to participant or compromise ability to tolerate experimental procedures or interfere with analysis of the study data as determined by the investigator
  • Has a history of risk factors for Torsades de Pointes or taking medications known to cause QT prolongation.
  • Has ECG acquired prior to initial 18F-AV-1451 scan that clinically contradicts subject's participation in the study as determined by the investigator. Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females).
  • Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods.
  • Has hypersensitivity to 18F-AV-1451.
  • Has a currently clinically significant infectious disease, endocrine/metabolic disease, pulmonary/renal/hepatic impairment, or cancer that could impact study participation or scan results in the opinion of the investigator.
  • Has a non-study related radiopharmaceutical imaging/treatment procedure within seven days prior to 18F-AV-1451 imaging visit.
  • Is unsuitable for a study of this type in the opinion of the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03052972

Contacts
Contact: Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact    410-955-1911      
Principal Investigator: Marilyn Albert, PhD         
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
  More Information

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT03052972     History of Changes
Other Study ID Numbers: 18F-AV-1451-A20
Study First Received: February 10, 2017
Last Updated: April 13, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on June 27, 2017