Personalized Treatment in Thyroid Disorders

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03517579
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cervical Collar Therapy Indicator (COTI) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 11, 2018
Status verified
Oct 2025
Primary completion
Oct 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Pilot Project
    It is a Pilot study of 10 persons

Primary Outcome Measure

Evaluation of the Variability in radioiodine kinetics for patients with thyroid cancer and graves disease [ Time Frame: 6-9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21247
Prasanna Santhanam

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By research site
Johns Hopkins Hospital· Baltimore, MD

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