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A Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron in Patients With Thyroid Scan Indication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307175
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Tracking Information
First Submitted Date September 24, 2014
First Posted Date December 4, 2014
Last Update Posted Date December 4, 2017
Actual Study Start Date September 1, 2014
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 1, 2014)
Biodistribution of Tc99m produced by high-energy cyclotron (CycloTec) [ Time Frame: 6 months ]
Equivalence of biodistribution of Tc99m produced by high-energy cyclotron (CycloTec) will be compared to the biodistribution of the conventional Tc99m pertechnetated (Case match: 1 CycloTec patient vs. 2 conventional Tc99m-pertechnetate patients)
Original Primary Outcome Measures Same as current
Change History
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 A Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron in Patients With Thyroid Scan Indication
Official Title A Phase I Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron (CYCLOTEC) in Patients With Thyroid Scan Indication
Brief Summary Prospective, open label single site study to demonstrate the safety and efficacy of Tc-99m pertechnetate produced by high energy cyclotron at CHUS.
Detailed Description The proposed clinical trial will be a prospective, case-controlled Phase I, open label, single site study. The first 10 consecutively enrolled patients will receive CYCLOTEC standard procedure thyroid imagery and an additional whole-body scans, and 20 subsequent case-matched controls, will receive GPERT and will also have additionnal whole body scan.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients between 18 and 80 years of age with thyroid scan indication
Condition
  • Autoimmune Thyroid Disease
  • Congenital Hypothyroidism
Intervention Not Provided
Study Groups/Cohorts
  • Cyclotec
    The first 10 consecutively enrolled patients will have thyroid and whole body scan with CycloTec
  • generator produced Tc99m-pertechnetate
    20 subsequent case-matched controls will have thyroid and whole body scan with conventional Tc99m-pertechnetate
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: December 1, 2014)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date October 31, 2016
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Prescribed thyroid scan
  • Provided written informed consent prior to participation
  • Biochemical parameters within 5 times of the normal limits for age
  • WBC count > 3.0/μL
  • ANC count 1.5/μL
  • Platelets > 75,000/μL
  • Haemoglobin > 10 g/dL
  • Karnofsky Performance Scale score > 50

Exclusion Criteria:

  • Nursing or pregnant females
  • Biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the scan
  • WBC < 3.0/μL
  • ANC < 1.5/μL
  • Platelets < 75,000/μL
  • Haemoglobin < 10 g/dL
  • Unable and unwilling to follow instructions and comply with the protocol
  • Unable or unwilling to provide written informed consent prior to participation in the study
  • Karnofsky Performance Scale score < 50
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02307175
Other Study ID Numbers CIMS-2014-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Study Sponsor Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborators Not Provided
Investigators
Principal Investigator: Eric Turcotte, MD Centre de recherche du Centre hospitalier universitaire de Sherbrooke
PRS Account Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Verification Date November 2017