Personalized Treatment in Thyroid Disorders

NCT03517579 | Recruiting

• 1 other identifier: IRB00157150
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  6-9 months

Secondary Outcomes (1)

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

  9-12 months

Study Arms (1)

Pilot Project

EXPERIMENTAL

It is a Pilot study of 10 persons

Device: Cervical Collar Therapy Indicator (COTI)

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.

Pilot Project

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with diseases involving cervical spine, such as spondylosis and severe degenerative joint disease.
• Pregnant Women, elderly and persons unable to understand simple instructions

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21247, United States

RECRUITING

Related Publications (3)

• Ladenson PW. Precision Medicine Comes to Thyroidology. J Clin Endocrinol Metab. 2016 Mar;101(3):799-803. doi: 10.1210/jc.2015-3695. Epub 2016 Feb 23.

  PMID: 26908108 BACKGROUND

• Brinks P, Van Gils K, Kranenborg E, Lavalaye J, Dieckens D, Habraken JBA. Measuring the actual I-131 thyroid uptake curve with a collar detector system: a feasibility study. Eur J Nucl Med Mol Imaging. 2017 Jun;44(6):935-940. doi: 10.1007/s00259-016-3595-y. Epub 2016 Dec 17.

  PMID: 27988801 RESULT

• Santhanam P, Solnes L, Nath T, Roussin JP, Gray D, Frey E, Sgouros G, Ladenson PW. Real-time quantitation of thyroidal radioiodine uptake in thyroid disease with monitoring by a collar detection device. Sci Rep. 2021 Sep 16;11(1):18479. doi: 10.1038/s41598-021-97408-y.

  PMID: 34531443 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms; Graves Disease

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Prasanna Santhanam, MBBS, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prasanna Santhanam, MBBS, MD

CONTACT

410-550-6023; psantha1@jhmi.edu

Paul Ladenson, MD

CONTACT

410-955-3663; ladenson@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot experimental study

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: May 7, 2018
• Study Start: December 11, 2018
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)