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Radioactive Isotope

I-124 PET/CT Dosimetry for Thyroid Cancer

Phase 2

Recruiting

Led By Joanna Klubo-Gwiezdzinska, M.D.

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

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

Must have

Age greater than or equal to 18 years of age

Patients with established thyroid cancer diagnosis based on the pathology report reviewed at the National Institutes of Health, who underwent total thyroidectomy +/- neck lymph node dissection as clinically indicated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 weeks

Awards & highlights

Study Summary

This trial is comparing the two methods of TSH stimulation (endogenous by thyroid hormone withdrawal leading to hypothyroidism and exogenous by injection of human recombinant TSH) in order to find the appropriate 131-I activity.

Who is the study for?

This trial is for adults over 18 with high-risk differentiated thyroid cancer, who've had a total thyroidectomy and may have distant metastases. They should not be pregnant or lactating, must be able to consent, and cannot have serious conditions like renal failure or non-thyroid cancers. Brain/spine metastasis patients are excluded due to risks from TSH-stimulation.Check my eligibility

What is being tested?

The study tests how well I-124 PET/CT dosimetry can predict the effective dose of I-131 therapy in thyroid cancer under two types of TSH stimulation: Thyrogen injections and hormone withdrawal. It's a phase 2 pilot comparing these methods within each patient over five years.See study design

What are the potential side effects?

Potential side effects include reactions related to iodine-based therapies such as nausea, sore throat, swelling at injection sites for Thyrogen, hypothyroid symptoms during hormone withdrawal, and general discomfort from imaging procedures.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have thyroid cancer, confirmed by NIH, and had my thyroid completely removed.

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I've had a CT or MRI with contrast of my brain and spine to check for cancer spread.

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My scans show my cancer has returned or spread.

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My cancer may have returned or spread, indicated by advanced tumor features or changes in my thyroglobulin levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 weeks

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

Treatment Details

Study Objectives

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

Primary outcome measures

Comparison of the whole body and lesional 124I uptake within each patient prepared for imaging with human recombinant TSH (rhTSH) and thyroid hormone withdrawal (THW)

Trial Design

2Treatment groups

Active Control

Group I: 124I PET/CT scan after thyroid hormone withdrawalActive Control3 Interventions

124I PET/CT scan after preparation with thyroid hormone withdrawal

Group II: 124I PET/CT scan after rhTSHActive Control3 Interventions

124I PET/CT scan after preparation with human recombinant TSH

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor

2,359 Previous Clinical Trials

4,315,473 Total Patients Enrolled

Joanna Klubo-Gwiezdzinska, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

5 Previous Clinical Trials

5,650 Total Patients Enrolled

Media Library

I-131 (Radioactive Isotope) Clinical Trial Eligibility Overview. Trial Name: NCT03841617 — Phase 2

Thyroid Cancer Research Study Groups: 124I PET/CT scan after thyroid hormone withdrawal, 124I PET/CT scan after rhTSH

Thyroid Cancer Clinical Trial 2023: I-131 Highlights & Side Effects. Trial Name: NCT03841617 — Phase 2

I-131 (Radioactive Isotope) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03841617 — Phase 2

Frequently Asked Questions

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

Are researchers still looking for participants in this trial?

"The study is currently looking for 30 patients from 1 location, as stated on clinicaltrials.gov. This information was originally posted on 29 July 2019 and updated 8 November 20202."

Answered by AI

Why do many people undergoing 124I PET/CT scans also stop taking thyroid medication?

"124I PET/CT scan can be used to monitor patients who have undergone radioiodine ablation of thyroid tissue, thyroidectomy, and thyroglobulin therapy after discontinuing use of thyroid hormone."

Answered by AI

Are there similar cases to mine involving 124I PET/CT scan after thyroid hormone withdrawal?

"There are currently 6 clinical trials underway for 124I PET/CT scan after thyroid hormone withdrawal. 2 of these trials have reached Phase 3. The remaining 4 are in earlier stages of research. Most studies for 124I PET/CT scan after thyroid hormone withdrawal originate from Beijing, but there are active trials in 6 different locations."

Answered by AI

Is the 124I PET/CT scan a reliable method to determine if thyroid hormone withdrawal is working?

"According to our team's evaluation, 124I PET/CT scan after thyroid hormone withdrawal falls at a 2 on the 1-3 scale. This is due to the fact that this is only a Phase 2 trial, so while there is some safety data supporting its use, there is none yet for efficacy."

Answered by AI

What other similar clinical trials exist for this condition?

"The use of 124I PET/CT scans after thyroid hormone withdrawal has been an area of active research since 2014. The first trial, which was sponsored by Genentech Inc., occurred that year and involved 12 patients. After the successful completion of the study, the drug received N/A approval. Currently, there are 6 ongoing clinical trials for this medication taking place in 4 cities across 3 countries."

Answered by AI

Could you give me the total patient count for this research project?

"Yes, the information on clinicaltrials.gov indicates that this study is actively seeking patients. The study was initially posted on 7/29/2019 and was last updated on 11/8/2022. The clinical trial is looking for 30 patients at 1 sites"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer

2019. "The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03841617.

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