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The Biodistribution of 1-L-(2 Deoxy-2,- 18 Fluoroarabinofuranosyl) Cytosine ([18F]L-FAC) in Healthy Subjects and Patients With Cancer, Autoimmune and Inflammatory Diseases

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ClinicalTrials.gov Identifier: NCT01180868
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : July 31, 2012
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date August 11, 2010
First Posted Date August 12, 2010
Last Update Posted Date July 31, 2012
Study Start Date May 2008
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01180868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Biodistribution of 1-L-(2 Deoxy-2,- 18 Fluoroarabinofuranosyl) Cytosine ([18F]L-FAC) in Healthy Subjects and Patients With Cancer, Autoimmune and Inflammatory Diseases
Official Title The Biodistribution of 1-L-(2 Deoxy-2,- 18 Fluoroarabinofuranosyl) Cytosine ([18F]L-FAC) in Healthy Subjects and Patients With Cancer, Autoimmune and Inflammatory Diseases
Brief Summary The purpose of this study is to determine the biodistribution of a new agent 1-L-(2 deoxy-2,-18fluoroarabinofuranosyl) cytosine non-invasively in healthy humans and to evaluate whether it can be used to image cancer, autoimmune disease, and inflammation
Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with cancer, patients with autoimmune dosorders, and healthy subjects.
Condition
  • Autoimmune Diseases
  • Cancer
Intervention Not Provided
Study Groups/Cohorts
  • patients with cancer
    patients with hematological malignancies and solid tumors
  • patients with autoimmune dosorders
    patients with Rheumatoid arthritis, Crohns's disease, systemic lupus erythematosus.
  • healthy subjects
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 14, 2012)
1
Original Estimated Enrollment
 (submitted: August 11, 2010)
30
Study Completion Date Not Provided
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • greater than 18 years of age
  • women of childbearing potential will undergo a pregnancy test free of charge
  • patients with hematological malignancies, solid tumors or autoimmune disorders
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01180868
Other Study ID Numbers 08-02-049
DE-PS02-08ER08-01 ( Other Grant/Funding Number: Department of Energy )
CIRM No. RT1-01126-1 ( Other Grant/Funding Number: California Institute for Regenerative Medicine )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor Jonsson Comprehensive Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Christiaan Schiepers, M.D. Ph.D University of California, Los Angeles
PRS Account Jonsson Comprehensive Cancer Center
Verification Date July 2012