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NCT03517579Suspended

Personalized Treatment in Thyroid Disorders

Personalized Treatment Planning for Radio-iodine Therapy of Thyroid Disease

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Reason given: Funding issues

Brief summary (registry, in English)

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.

Status (registry)
Suspended
Study type
Interventional
Enrollment
10 (estimated)
First submitted
3 Apr 2018
Start date
11 Dec 2018
Primary completion date
15 Oct 2027
Lead sponsor
Johns Hopkins University
NCT number
NCT03517579

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with diseases involving cervical spine, such as spondylosis and severe degenerative joint disease.

Other

  • Pregnant Women, elderly and persons unable to understand simple instructions

Who the study is looking for

  • 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.

Age in the registry: 21 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Johns Hopkins HospitalBaltimoreUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.