Recruiting

Thyroid Disorders

Sponsor:

Johns Hopkins University

Code:

NCT03517579

Conditions

Thyroid Cancer

Graves Disease

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Cervical Collar Therapy Indicator (COTI)

Study Details

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.

Conditions

Thyroid Cancer

Graves Disease

Study ID

NCT03517579

Start date

Dec 11, 2018

Status verified date

Oct, 2025

Completion date

Dec 15, 2027

Anticipated

Primary completion date

Oct 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Pilot Project

It is a Pilot study of 10 persons

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Prasanna Santhanam, MBBS, MD

410-550-6023psantha1@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21247

More Information

Sponsor

Johns Hopkins University

Last update posted

Oct 15, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.