NCT03517579 Personalized Treatment in Thyroid Disorders
| NCT ID | NCT03517579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Thyroid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2018-12-11 |
| Primary Completion | 2027-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2018-12-11 with a primary completion date of 2027-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Prasanna Santhanam, MBBS, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT03517579 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03517579 currently recruiting?
Yes, NCT03517579 is actively recruiting participants. Contact the research team at psantha1@jhmi.edu for enrollment information.
Where is the NCT03517579 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT03517579 clinical trial?
NCT03517579 is sponsored by Johns Hopkins University. The principal investigator is Prasanna Santhanam, MBBS, MD at Johns Hopkins University. The trial plans to enroll 10 participants.
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