Clinical trial · Interventional
Personalized Treatment in Thyroid Disorders
Personalized Treatment Planning for Radio-iodine Therapy of Thyroid Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graves Disease | — | UNRESOLVED | — |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervical Collar Therapy Indicator (COTI) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pilot Project
- description
- It is a Pilot study of 10 persons
- interventionNames
- Device: Cervical Collar Therapy Indicator (COTI)
Primary outcomes (1)
- measure
- Evaluation of the Variability in radioiodine kinetics for patients with thyroid cancer and graves disease
- timeFrame
- 6-9 months
- description
- 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
Secondary outcomes (1)
- measure
- Validation of the device as an enhancement of quantitative measurements in patients with Graves disease and thyroid cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDLadenson 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
- RESULTBrinks 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
- DERIVEDSanthanam 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