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Trial record 7 of 633 for:    Alexander Disease

A Study to Compare the Safety and Imaging Pattern of Cyclotron-produced Technetium (CTC) vs. Generator-produced Technetium (G-PERT) in People With Thyroid Disorders Who Need Surgery

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ClinicalTrials.gov Identifier: NCT02980679
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Alexander McEwan, University of Alberta

Brief Summary:

A 99mTc Pertechnetate (G-PERT) scan is a nuclear medicine test that can create an image of the thyroid gland and other organs. G-PERT is approved by Health Canada for the direct imaging and measurement of thyroid uptake.

Doctors and researchers at the University of Alberta have developed a new method of producing 99mTc Pertechnetate (called CTC). It is made in a cyclotron at the Medical Isotope and Cyclotron Facility (MICF) at the University of Alberta, Edmonton, Alberta. This new production method will provide another source of 99mTc Pertechnetate. The aim of this study is to confirm that CTC is safe and can be used interchangeably with G-PERT.


Condition or disease Intervention/treatment Phase
Thyroid Gland Diseases Drug: CTC Drug: G-PERT Phase 3

Detailed Description:
The clinical trial will be a Phase III, prospective, crossover, image interpretation blinded, single site study. All subjects will receive Tc-99m pertechnetate (one CTC and one G-PERT administration separated by at least 48 hours) and subsequently be imaged for thyroid uptake and whole body biodistribution. The order of the scans will be randomized. The thyroid image will be interpreted for uptake / no uptake in the thyroid, and the whole body biodistribution image will be interpreted for uptake / no uptake in selected anatomical sites. Interpretation of thyroid imaging results will be compared with other clinical findings (such as pre-surgical ultrasound, fine needle aspirate, and post-surgical pathology results, when available). All imaging assessments will be conducted by 1 blinded Nuclear Medicine physician. A safety evaluation will be conducted on all subjects receiving CTC, consisting of vital signs, haematology and SMA-12 serum biochemistry profile (pre-injection and post-imaging), and, for both CTC and G-PERT, an adverse event assessment (until the subject leaves the Nuclear Medicine department) after each administration.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pivotal Phase III Study of Cyclotron-produced Tc-99m Pertechnetate (CTC) Compared to Generator-produced Tc-99m Pertechnetate (G-PERT) in Subjects With Thyroid Disorders
Actual Study Start Date : March 3, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CTC and G-PERT Imaging
One experimental (CTC) and one standard (G-PERT) scan, at least 48 hours apart, before thyroid surgery. The order of the scans will be randomized.
Drug: CTC
After injection of CTC, a whole body and thyroid scan will be performed.
Other Name: Cyclotron-produced technetium
Drug: G-PERT
After injection of G-PERT, a whole body and thyroid scan will be performed.
Other Name: Generator-produced technetium



Primary Outcome Measures :
  1. Clinical Comparability of CTC with G-PERT [ Time Frame: up to 1 year ]

    The primary efficacy endpoint is the clinical comparability of CTC with G-PERT consisting of a combination of the following results:

    1. A thyroid image, assessed for uptake or no uptake in the thyroid.
    2. A whole body biodistribution study, assessed for uptake or no uptake in selected anatomical areas.


Secondary Outcome Measures :
  1. Change in vital signs after CTC injection [ Time Frame: Before CTC injection and after CTC scan (within ~30 min) ]
    Vital signs are measured before injection of CTC and after CTC scan and changes will be summarized.

  2. Changes in haematology / SMA-12 serum biochemistry after CTC injection [ Time Frame: Before CTC injection and after CTC scan (within ~30 min) ]
    A blood sample is drawn before injection of CTC and after CTC scan. The haematology and SMA-12 serum biochemistry parameters will be recorded and all changes will be summarized.

  3. Number of participants with adverse events [ Time Frame: up to 1 year ]
    Subjects will be monitored for adverse events after CTC and G-PERT scans while in the Nuclear Medicine Department. All adverse events observed or reported will be recorded and assessed.

  4. Correlation of CTC with other clinical findings [ Time Frame: up to 1 year ]
    Correlation of thyroid images with other clinical findings (such as pre-surgical ultrasound, FNA, and post-surgical pathology results, when available).

  5. CTC diagnostic outcomes and parameters [ Time Frame: up to 1 year ]
    Calculation of diagnostic outcomes (TP, TN, FP, FN) and the corresponding diagnostic parameters (sensitivity, specificity, accuracy).

  6. Overall clinical comparability of CTC with G-PERT [ Time Frame: up to 1 year ]
    The overall clinical comparability of CTC with G-PERT using diagnostic outcomes (True Positive, True Negative, False Positive, False Negative) to determine the corresponding diagnostic parameters (sensitivity, specificity, accuracy).



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥ 18 years of age and < 80 years of age.
  2. Have a proven or suspected thyroid pathology that requires surgery by standard clinical criteria.
  3. Able and willing to follow instructions and comply with the protocol.
  4. Provide written informed consent prior to participation in the study.

Exclusion Criteria:

1. Nursing or pregnant females.


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): NCT02980679


Contacts
Contact: Lai Schrader 780-432-8464 Lai.Schrader@ahs.ca
Contact: Marguerite Wieler, BScPT, PhD 780-391-7634 Marguerite.Wieler@ahs.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Sub-Investigator: Todd McMullen, MD, PhD, FRCSC, FACS         
Sub-Investigator: Marguerite Wieler, BScPT, PhD         
Sub-Investigator: Terence Riauka, PhD         
Sponsors and Collaborators
Alexander McEwan
Investigators
Principal Investigator: Alexander (Sandy) JB McEwan, MB, FRCPC Professor, Department of Oncology

Responsible Party: Alexander McEwan, Professor, Department of Oncology, University of Alberta
ClinicalTrials.gov Identifier: NCT02980679     History of Changes
Other Study ID Numbers: DX-CTC-003
HREBA.CC-16-0695 ( Other Identifier: Health Research Ethics Board of Alberta Cancer Committee )
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases
Sodium Pertechnetate Tc 99m
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action