Personalized Treatment in Thyroid Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorJohns Hopkins University

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Pregnant Women, elderly and persons unable to understand simple instructions

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Pilot ProjectExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Radioactive iodine uptake at different time points will be taken over a 24 hour period (7 days for thyroid cancer) and then the Area Under the Curve (AUC) will be Plotted.The AUC would then be correlated with the 24 hour uptake in Graves and day 7 uptake for thyroid cancer.We will use non-parametric tests to measure the correlation

Time frame
6-9 months

Secondary outcomes

1

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

Using SPECT-CT (the best current method for quantitative measurements of the thyroid uptake) ,we will compute the uptake of I-131 at different time points (as mentioned in the protocol) and correlate it with the AUC (computed by the COTI device) and see the degree of congruity. In the case of graves disease patients, the 6 hour and 24 hour uptake (standard of care) would be measured against the COTI AUC

Time frame
9-12 months

Other outcomes

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