Clinical trial for Thyroid Cancer
Official title The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer
ClinicalTrials.gov ID: NCT03841617
What this study is testing
What is Thyrogen?
an investigational injectable medicine being studied for high‑risk differentiated thyroid cancer is designed to stimulate TSH receptors, raising thyroid cells’ ability to take up radioactive iodine
Also referred to as recombinant human TSH (rhTSH).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares 124‑I PET/CT dosimetry during two types of thyroid‑stimulating hormone (TSH) preparation, using a drug (rhTSH) and by stopping thyroid hormone (THW). It also looks at whether the PET/CT results predict how well the cancer responds to treatment.
- Who it's for
- Adults with high‑risk differentiated thyroid cancer that has spread to other parts of the body or nearby lymph nodes.
- What's involved
- Participants will have two 124‑I PET/CT scans, one after rhTSH injection and one after stopping thyroid hormone. The scans will help calculate the safest and most effective dose of radioactive iodine (131‑I) for their treatment. They will then receive the calculated dose and be monitored over time.
- Time commitment
- The study lasts about five years, with follow‑up visits every 12 ± 3 months after treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- underwent total thyroidectomy plus or minus neck lymph node dissection as clinically indicated,
- are presenting with known per structural imaging (US neck, CT or MRI neck/chest/abdomen/pelvis) persistent/recurrent disease either locally advanced...
- are presenting with suspected persistent/recurrent locoregional or distant metastases based on the high risk features such as advanced tumor per...
- are either RAI -naive or requiring repeated RAI therapy for locally advanced disease or distant metastases or underwent therapy with BRAF inhibitor...
- Underwent imaging with either a CT or MRI of the brain and spine with gadolinium contrast to screen for the brain/spine metastases.
You likely can't join if
- -Patients with RAI-non avid disease documented by negative post-therapy whole body scans performed after previous RAI treatments and not subjected to...
- Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active...
- Patients with spinal or brain metastases as they are at risk of TSH-stimulation induced swelling of metastatic lesions leading to potentially...
- Pregnant or lactating women per self report.
- Adults who are incapable of providing informed consent.
See the full eligibility criteria
- underwent total thyroidectomy plus or minus neck lymph node dissection as clinically indicated,
- are presenting with known per structural imaging (US neck, CT or MRI neck/chest/abdomen/pelvis) persistent/recurrent disease either locally advanced or presenting with distant metastases; or
- are presenting with suspected persistent/recurrent locoregional or distant metastases based on the high risk features such as advanced tumor per pathology report (tumor size \>4 cm, exrathyroidal extension, higher risk...
- are either RAI -naive or requiring repeated RAI therapy for locally advanced disease or distant metastases or underwent therapy with BRAF inhibitor (dabrafenib or vemurafenib\ ) or selumetinib\ \ for at least 4 weeks...
- Underwent imaging with either a CT or MRI of the brain and spine with gadolinium contrast to screen for the brain/spine metastases.
- Age greater than or equal to 18 years of age.
- 24 hour urine iodine excretion of less than or equal to 150 micro grams/24 hour.
- BRAF inhibitors are recommended by 2021 NCCN guidelines as one of the management options for BRAF mutant tumors(13,14)
- Selumetinib has an FDA orphan drug designation for adjuvant treatment of metastatic thyroid cancer to re-induce RAI uptake
- -Patients with RAI-non avid disease documented by negative post-therapy whole body scans performed after previous RAI treatments and not subjected to re-differentiation therapy.
- Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma, severe depression which might be...
- Patients with spinal or brain metastases as they are at risk of TSH-stimulation induced swelling of metastatic lesions leading to potentially detrimental side effects.
- Pregnant or lactating women per self report.
- Adults who are incapable of providing informed consent.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.