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Cervical Collar Device for Thyroid Disorders

N/A

Recruiting

Led By Prasanna Santhanam, MBBS, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Group I: Patients with Graves' disease confirmed by laboratory testing. Patients able to understand English and able to follow instructions.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9-12 months

Awards & highlights

Study Summary

This trial is testing a device that is worn around the neck and measures radioiodine exposure to help estimate the amount of iodine-131 that a person needs for treatment of thyroid disorders while minimizing risks of comorbidities.

Who is the study for?

This trial is for English-speaking individuals with Graves' disease confirmed by lab tests or those with intermediate/high-risk thyroid cancer needing radioiodine treatment. It's not suitable for pregnant women, the elderly, or anyone with certain cervical spine diseases.Check my eligibility

What is being tested?

The study is testing a neck collar device called CoTI that measures radiation exposure from radioiodine treatments in real-time. This could lead to more accurate doses of radioactive iodine and reduce clinic visits compared to current methods.See study design

What are the potential side effects?

While specific side effects are not listed, participants may experience discomfort wearing the CoTI device around their necks. The survey will assess patient experiences including any inconvenience or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a certain type of thyroid cancer needing specific treatment and can understand and follow instructions in English.

Select...

I have Graves' disease confirmed by tests and I understand and can follow instructions in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pilot ProjectExperimental Treatment1 Intervention

It is a Pilot study of 10 persons

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,260 Previous Clinical Trials

14,820,665 Total Patients Enrolled

Prasanna Santhanam, MBBS, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Pilot Project Clinical Trial Eligibility Overview. Trial Name: NCT03517579 — N/A

Thyroid Cancer Research Study Groups: Pilot Project

Thyroid Cancer Clinical Trial 2023: Pilot Project Highlights & Side Effects. Trial Name: NCT03517579 — N/A

Pilot Project 2023 Treatment Timeline for Medical Study. Trial Name: NCT03517579 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still recruiting participants for this experiment?

"Affirmative. The data available on clinicaltrials.gov attests that this investigation is currently seeking applicants, having initially been published on December 11th 2018 and revised most recently as of October 5th 2022. This experiment necessitates 10 participants from a single site for enrolment."

Answered by AI

Does the protocol for this trial encompass elderly individuals?

"This medical trial includes a lower limit of 21 years old and an upper bound at 65. Consequently, all participants must fall within this age bracket to be eligible for inclusion in the study."

Answered by AI

What criteria must a participant meet in order to qualify for this research?

"Individuals between 21 and 65 years old with a diagnosis of Graves disease are eligible to apply for this study, which is limited to 10 participants."

Answered by AI

What is the current size of the participant pool for this clinical investigation?

"Affirmative. As per the clinicaltrials.gov records, this clinical trial is still enrolling individuals and was first launched on December 11th 2018 with its most recent update occurring October 5th 2022. A total of 10 people are expected to join from one select medical centre."

Answered by AI

Recent research and studies

The Journal of Clinical Endocrinology & MetabolismJournal

Precision Medicine Comes to Thyroidology

Ladenson, Paul W.. 2016. “Precision Medicine Comes to Thyroidology”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2015-3695.

European Journal of Nuclear Medicine and Molecular ImagingJournal

Measuring the Actual I-131 Thyroid Uptake Curve with a Collar Detector System: A Feasibility Study

Brinks, Peter, Koen Van Gils, Ellen Kranenborg, Jules Lavalaye, Dennis B. M. Dickerscheid, and Jan B. A. Habraken. 2016. “Measuring the Actual I-131 Thyroid Uptake Curve with a Collar Detector System: A Feasibility Study”. European Journal of Nuclear Medicine and Molecular Imaging. Springer Science and Business Media LLC. doi:10.1007/s00259-016-3595-y.

Scientific ReportsJournal

Real-time Quantitation of Thyroidal Radioiodine Uptake in Thyroid Disease with Monitoring by a Collar Detection Device

Santhanam, Prasanna, Lilja Solnes, Tanmay Nath, Jean-Paul Roussin, David Gray, Eric Frey, George Sgouros, and Paul W. Ladenson. 2021. “Real-time Quantitation of Thyroidal Radioiodine Uptake in Thyroid Disease with Monitoring by a Collar Detection Device”. Scientific Reports. Springer Science and Business Media LLC. doi:10.1038/s41598-021-97408-y.

clinicaltrials.govStudy