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NCT03517579 · ClinicalTrials.gov registry record · NA
Personalized Treatment in Thyroid Disorders
A NA study of Thyroid Cancer and Graves Disease, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03517579: Recruiting NA study of Thyroid Cancer and Graves Disease, sponsored by Johns Hopkins University.
NCT03517579 is a NA study of Thyroid Cancer and Graves Disease that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 10 participants, below the 282-participant average among 46 other Thyroid Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03517579, a NA study of Thyroid Cancer and Graves Disease, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Cervical Collar Therapy Indicator (COTI)
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-12-11 |
| Est. Completion | 2027-12-15 |
| Phase | NA |
What NCT03517579 shows while recruiting
NCT03517579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 282-participant average among 46 other Thyroid Cancer trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Thyroid Cancer appearing as the primary indexed condition, and to 1 intervention - of which Cervical Collar Therapy Indicator (COTI) is the first listed.
NCT03517579 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03517579 about?
NCT03517579 is a clinical study titled "Personalized Treatment in Thyroid Disorders". 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 conventio...
What is the current status of trial NCT03517579?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2018-12-11. Estimated completion is 2027-12-15.
What conditions does trial NCT03517579 study?
This clinical trial studies the following conditions: Thyroid Cancer, Graves Disease.
What interventions are being tested in trial NCT03517579?
The interventions under investigation include: Cervical Collar Therapy Indicator (COTI) (DEVICE).
Who is sponsoring clinical trial NCT03517579?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03517579 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03517579's enrollment target sits among peer trials
10 44th of 46 higher than 2 of 46 other Thyroid Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Thyroid Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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