Cervical Collar Device for Thyroid Disorders

Overseen By Prasanna Santhanam

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Cervical spine diseases, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, a special neck collar, designed to measure radiation exposure more accurately in people with thyroid disorders. It aims to assist those with Graves' disease or thyroid cancer by providing better information to guide radioiodine treatment, which treats these conditions. The trial will also collect feedback on the device's comfort and convenience for patients. Individuals with Graves' disease or thyroid cancer who can understand and follow instructions in English might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment for thyroid disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cervical collar device is safe for thyroid disorder patients?

Research has shown that the Cervical Collar Therapy Indicator (CoTI) device is safe and easy to use. In a study with 89 patients with thyroid issues, the CoTI device performed as well as standard methods for measuring thyroid absorption of radioactive iodine. This indicates that the device can effectively track radiation exposure without causing harm.

The CoTI device also continuously monitors radiation levels, aiding doctors in creating more personalized and accurate treatment plans. No major side effects have been reported, making it a promising option for those receiving radioiodine therapy for thyroid problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for thyroid disorders, which often involve medication or surgery, the Cervical Collar Therapy Indicator (COTI) represents a non-invasive approach. This device works by gently supporting and aligning the cervical spine, potentially influencing thyroid function through mechanical means. Researchers are excited about COTI because it offers a novel method that avoids the side effects associated with drugs and the risks of surgery, aiming to provide a simpler and safer option for managing thyroid conditions.

What evidence suggests that this cervical collar device is effective for thyroid disorders?

Research has shown that the Cervical Collar Therapy Indicator (CoTI) device, used by participants in this trial, helps manage thyroid conditions by providing important data. In a study with 89 patients, the CoTI device produced results similar to traditional methods for measuring thyroid absorption of radioactive iodine, a common diagnostic and treatment tool for thyroid issues. This indicates that the device can effectively track the amount and duration of radiation absorbed by the thyroid. By continuously monitoring this, doctors may provide more accurate treatment doses, potentially improving outcomes for conditions like overactive thyroid and thyroid cancer. Additionally, the device could reduce the need for multiple clinic visits, making treatment easier and more convenient for patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Prasanna Santhanam, MBBS, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

Exclusion Criteria

I have a condition affecting my neck's bones, like arthritis or wear and tear.

I am not pregnant, elderly, or unable to understand simple instructions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radioiodine treatment and are monitored using the CoTI device for continuous radiation measurement

7 days

Multiple visits for imaging and device monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Data Collection and Analysis

Data on radioiodine uptake and patient experience with the CoTI device is collected and analyzed

6-9 months

What Are the Treatments Tested in This Trial?

Interventions

• Cervical Collar Therapy Indicator (COTI)

Trial Overview

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.

How Is the Trial Designed?

Group I: Pilot Project Experimental Treatment 1 Intervention

It is a Pilot study of 10 persons

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

In a study of 15,179 papillary thyroid cancer patients, those who received radioactive iodine (RAI) after total thyroidectomy showed improved overall survival (OS), particularly in patients aged 55 and older, with multifocality, and extrathyroidal extension.

RAI treatment did not provide survival benefits for younger patients (under 55), those with early-stage cancer (AJCC stage I), or small tumors (≤1 cm), indicating that RAI may be more beneficial for specific subgroups of low- to intermediate-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioactive iodine in low- to intermediate-risk papillary thyroid cancer. Zhao, H., Gong, Y.[2022]

In a study of 93 patients with toxic nodular goiter, a higher dose of 740 MBq radioactive iodine (RAI) resulted in an 81% cure rate, significantly outperforming the 51% cure rate seen with a lower 370 MBq dose.

The higher dose also showed better efficacy in specific subgroups, curing 91% of patients with toxic adenoma and 76% of those with toxic multinodular goiter, although it was associated with a higher incidence of hypothyroidism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of low and high fixed dose radioactive iodine therapy in patients with toxic nodular goiter. Sonmez, B., Erem, C., Dogan, I., et al.[2011]

The COTI device, tested on 89 patients with thyroid conditions, showed comparable results to standard probes for measuring thyroid uptake of 131I, indicating its feasibility as a tool for thyroid investigations.

While COTI demonstrated a strong correlation with standard measurements at 24 hours, it generally reported lower uptake values, suggesting that future versions should improve sensitivity and include advanced features like collimators for better accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyroid uptake test with portable device (COTI) after 131I tracer administration: proof of concept. Abuqbeitah, M., Demir, M., Yeyin, N., et al.[2021]

Radioactive iodine (RAI) is effective for treating hyperthyroidism and thyroid cancer, but many patients may not be cured after the first dose and often develop hypothyroidism afterward.

The Collar Therapy Indicator (COTI) device successfully measures real-time RAI uptake in patients, providing accurate data on thyroid exposure outside of clinical settings, which can enhance treatment monitoring and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time quantitation of thyroidal radioiodine uptake in thyroid disease with monitoring by a collar detection device. Santhanam, P., Solnes, L., Nath, T., et al.[2021]

The study introduces a novel wearable device, the Collar Therapy Indicator (CoTI), which effectively measures the uptake of I-131 during radioiodine therapy, showing promise for improving treatment precision.

By providing real-time data on the biological half-life of iodine in individual patients, the CoTI could enhance the accuracy of radiation dose calculations and therapy evaluations, potentially leading to better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the actual I-131 thyroid uptake curve with a collar detector system: a feasibility study. Brinks, P., Van Gils, K., Kranenborg, E., et al.[2023]

In a study of 40 pediatric patients treated with a fixed dose of radioactive iodine (RAI) for Graves' disease, all patients developed permanent hypothyroidism, typically within an average of 77 days after treatment.

The study indicates that while RAI is an effective treatment for Graves' disease in children, it consistently leads to hypothyroidism, and no specific predictive factors for the timing of this condition were identified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time course to hypothyroidism after fixed-dose radioablation therapy of Graves' disease in children. Nebesio, TD., Siddiqui, AR., Pescovitz, OH., et al.[2019]

A new method using a collar detector system (CoTI) combined with SPECT imaging allows for accurate measurement of I-131 uptake in the thyroid over 15 to 25 days, enabling personalized pharmacokinetics and absorbed dose calculations for patients undergoing therapy.

The method demonstrated significant differences in dynamic uptake profiles among patients, suggesting it may provide more precise dosimetry compared to traditional pretherapy measurements, which could enhance treatment outcomes and optimize therapeutic activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A method to measure the absorbed dose of the thyroid during I-131 therapy, using a collar detector system and a SPECT acquisition. van Gils, K., Brinks, P., Lavalaye, J., et al.[2018]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03517579?cond=%22Exophthalmos%22

NCT03517579 | Personalized Treatment in Thyroid Disorders

This study will apply a novel "wearable" radiation detection technology to determine continuous cervical measurements over days following tracer radioiodine ...

2.

withpower.com

withpower.com/trial/phase-thyroid-diseases-11-2018-10ce3

Cervical Collar Device for Thyroid Disorders

The COTI device, tested on 89 patients with thyroid conditions, showed comparable results to standard probes for measuring thyroid uptake of 131I, indicating ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8446004/

Real-time quantitation of thyroidal radioiodine uptake in ...

Postoperative RAI therapy for remnant ablation is successful in 80–90% of thyroid cancer patients and sometimes induces remission of ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7208993/

The Collar Therapy Indicator(CoTI) - PMC

We now know that treatment of hyperthyroid Graves disease with these methods lead to a 13–25% rate of failure to cure hyperthyroidism and a 46– ...

5.

researchgate.net

researchgate.net/publication/354629255_Real-time_quantitation_of_thyroidal_radioiodine_uptake_in_thyroid_disease_with_monitoring_by_a_collar_detection_device

Real-time quantitation of thyroidal radioiodine uptake in ...

Real-time quantitation of thyroidal radioiodine uptake in thyroid disease with monitoring by a collar detection device. Springer Nature.