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Personalized Treatment in Thyroid Disorders

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ClinicalTrials.gov Identifier: NCT03517579
Recruitment Status : Recruiting
First Posted : May 7, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
The Collar Therapy Indicator (CoTI) (A device that is placed in collar around the neck resembling a turtle neck sweater collar with a wire and recording box) has been shown in a single small previously published experience to provide data regarding radioiodine exposure that correlates with conventional methods of measuring I-123 and I-131 uptakes after diagnostic dose administration and/or therapy for thyroid disorders. We hypothesize that the device's continuous measurement capability will permit more accurate estimates of radiation exposure to thyroid tissue than conventionally employed methods assessing fractional uptake at one or a few time points. It may also provide information about the extent of variability in the absorbed radiation dose among patients with thyroid cancer and hyperthyroidism. By providing more complete information about individual patient's exposures, it will facilitate more accurate estimation of the administered I-131 dose requirements for control of hyperthyroidism and thyroid remnant ablation while reducing the need for repeated visits to the clinic for dosimetry measurements. The aims of our project include the following: (1)To compare quantitative imaging-derived thyroid time activity curve to that obtained using the CoTI and to determine the extent to which there is variability in radiation dose predicted using conventional methods to that predicted from measurement of the full Time-Activity Curve (TAC).(2) Evaluate the uptake and clearance kinetics across the 5 patients in each category as proof of principle for a potential larger trial to investigate use of this device in optimizing the administered doses of radioactive iodine to achieve therapeutic goals while minimizing risks of comorbidities, such a post-radioiodine hypothyroidism in patients with Graves' disease.(3)Evaluate patient experience, convenience, and discomfort in using the CoTI device with a survey instrument.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Graves Disease Device: Cervical Collar Therapy Indicator (COTI) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a pilot experimental study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Personalized Treatment Planning for Radio-iodine Therapy of Thyroid Disease
Actual Study Start Date : December 11, 2018
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arm Intervention/treatment
Experimental: Pilot Project
It is a Pilot study of 10 persons
Device: Cervical Collar Therapy Indicator (COTI)

Study Device; The CoTI has 3 components;

  • A collar unit: a gamma detector wrapped around a body part-neck in this case and contains a scintillating crystal and a silicon photomultiplier. The photon pulse signal is then converted to digital signals (measuring the counts per second). Usually two detectors are placed in specified positions.
  • A cable that connects the collar unit to the Control Unit
  • A control unit that collects the signals and transmits it wirelessly to a hand-held computer tablet.

Two types of collar devices will be used: the lower activity and the medium activity

  1. Lower activity collar for patients with Graves' disease as well as diagnostic I-123 scan in thyroid cancer patients. These patients typically receive 0.2-1.2 m Ci of I-123/I-131.
  2. Medium activity collar for Patients with thyroid cancer after 131-I ablation, for which patients typically receive 30-100 mci of I-131.




Primary Outcome Measures :
  1. Evaluation of the Variability in radioiodine kinetics for patients with thyroid cancer and graves disease [ Time Frame: 6-9 months ]
    Radioactive iodine uptake at different time points will be taken over a 24 hour period (7 days for thyroid cancer) and then the Area Under the Curve (AUC) will be Plotted.The AUC would then be correlated with the 24 hour uptake in Graves and day 7 uptake for thyroid cancer.We will use non-parametric tests to measure the correlation


Secondary Outcome Measures :
  1. Validation of the device as an enhancement of quantitative measurements in patients with Graves disease and thyroid cancer [ Time Frame: 9-12 months ]
    Using SPECT-CT (the best current method for quantitative measurements of the thyroid uptake) ,we will compute the uptake of I-131 at different time points (as mentioned in the protocol) and correlate it with the AUC (computed by the COTI device) and see the degree of congruity. In the case of graves disease patients, the 6 hour and 24 hour uptake (standard of care) would be measured against the COTI AUC



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Group I

    • Patients with Graves' disease confirmed by laboratory testing.
    • Patients able to understand English and able to follow instructions. Group II
    • Patients with intermediate and high risk differentiated thyroid cancer requiring radioiodine remnant ablation or moderately high dose I-131 for treatment of residual cervical disease.
    • Persons able to understand simple English and able to follow instructions.

Exclusion Criteria:

  • Patients with diseases involving cervical spine, such as spondylosis and severe degenerative joint disease.
  • Pregnant Women, elderly and persons unable to understand simple instructions

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): NCT03517579


Contacts
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Contact: Prasanna Santhanam, MBBS, MD 410-550-6023 psantha1@jhmi.edu
Contact: Paul Ladenson, MD 410-955-3663 ladenson@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21247
Contact: Prasanna Santhanam         
Sponsors and Collaborators
Johns Hopkins University

Publications of Results:
Other Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03517579     History of Changes
Other Study ID Numbers: IRB00157150
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Other than the study researchers, the data will not be shared with anyone else

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Graves Disease
Thyroid Diseases
Endocrine System Diseases
Orbital Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Exophthalmos
Goiter
Hyperthyroidism