NCT03517579

Personalized Treatment in Thyroid Disorders

StatusSuspended

PhaseNot applicable

SponsorJohns Hopkins University

Primary completionOct 15, 2027 (estimated)

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Record History

All 16 versions: 13 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

Stopped Oct 19, 2026 Recruitment suspended Sponsor's reason: Funding issues Show 5 more changesShow less
- Eligibility criteria expanded, about 7 words
- Secondary endpoints: details revised at 1 of 1 entry
- Study description expanded, about 26 words
- Site details revised
- Publications: details revised at 3 of 3 entries
Notable Oct 13, 2025 Primary completion date: Oct 15, 2026 to Oct 15, 2027
- Study completion date: Dec 15, 2026 to Dec 15, 2027
v15
Notable Oct 2, 2024 Primary completion date: Oct 15, 2024 to Oct 15, 2026
- Study completion date: Dec 15, 2024 to Dec 15, 2026
v14
Notable Oct 6, 2021 Primary completion date: Oct 15, 2021 to Oct 15, 2024
- Study completion date: Dec 15, 2021 to Dec 15, 2024
v11
Notable Oct 13, 2020 Primary completion date: Oct 15, 2020 to Oct 15, 2021
- Study completion date: Dec 15, 2020 to Dec 15, 2021
v10

Show 7 earlier versionsHide 7 earlier versions

Minor Dec 10, 2018 Start date changed from estimate of Dec 15, 2018 to Dec 11, 2018v8
Minor Dec 3, 2018 Start date: Nov 21, 2018 to Dec 15, 2018v7
Notable Nov 21, 2018 Trial status: Not Yet Recruiting to Recruiting
- Study sites: 0 to 1
- Start date: Nov 1, 2018 to Nov 21, 2018
v6
Notable Oct 3, 2018 Primary completion date: Oct 15, 2018 to Oct 15, 2020
- Start date: Sep 1, 2018 to Nov 1, 2018
- Study completion date: Dec 15, 2018 to Dec 15, 2020
v5
Notable Aug 16, 2018 Start date: Aug 1, 2018 to Sep 1, 2018v4
Notable Jun 20, 2018 Start date: May 15, 2018 to Aug 1, 2018v3
Minor May 7, 2018 Study description shortened, about 722 wordsv2

Apr 23, 2018 Study First Submitted

Stopped: terminated, suspended or withdrawn
Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Evaluation of the Variability in radioiodine kinetics for patients with thyroid cancer and graves disease

Timeframe: 6-9 months

Secondary (1)

Validation of the device as an enhancement of quantitative measurements in patients with Graves disease and thyroid cancer

Arms and interventions

Pilot ProjectExperimental

It is a Pilot study of 10 persons

Devices: Cervical Collar Therapy Indicator (COTI)

Sites

1 site in 1 country

Johns Hopkins HospitalBaltimore, Maryland, United States

About this trial

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.

Trial details

Enrollment: 10 participants (estimated)
Started: Dec 11, 2018
Study completion: Dec 15, 2027 (estimated)
Eligibility: 21 to 65, all sexes, no healthy volunteers
Design: Interventional, open label, diagnostic
Oversight: No data monitoring committee
Conditions: Graves Disease, Thyroid Neoplasms, Thyroid Cancer
Official title: Personalized Treatment Planning for Radio-iodine Therapy of Thyroid Disease
First posted: May 7, 2018
Registry updated: Oct 22, 2026
Last verified: Oct 2026

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