RecruitingNot ApplicableNCT03517579

Personalized Treatment in Thyroid Disorders

Personalized Treatment Planning for Radio-iodine Therapy of Thyroid Disease


Sponsor

Johns Hopkins University

Enrollment

10 participants

Start Date

Dec 11, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria2

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

Interventions

DEVICECervical 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.


Locations(1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

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NCT03517579


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