NCT06443866Recruiting
I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer
CLINICAL UTILITY AND FEASIBILITY OF I-124 PET/CT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER
Source: ClinicalTrials.gov · Last updated 5 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The objective of this study is to demonstrate the clinical utility of I-124 PET/CT imaging and dosimetry in patients with thyroid cancer including 1) Evaluation of extent (volume and pattern) of remnant tissue in post total thyroidectomy setting and distinction of nodal metastases vs remnant tissue for determination of indication for RAI ablation, 2) Evaluation of response to RAI remnant ablation, 3) Evaluation for suspected occult recurrent/metastatic disease, 4) Evaluation of extent of disease in patients with known metastatic disease and 5) Evaluation of RAI avidity of recurrent/metastatic thyroid cancer and response to treatment with thyroid kinase inhibitors (TKI). Patients who underwent total thyroidectomy for thyroid cancers are studied. Patients who are newly diagnosed, as well as those who have known or suspected to have recurrent or metastatic disease are eligible. Patients receiving TKI treatment are eligible for evaluation prior to and after the treatment. The patients who are considered for TKI/MAPK treatments undergo pre and post treatment with clinically determined oncoprotein/TKR therapeutic agent(s), including multi-TKI, selective BRAF, MEK, PI3K or ERK inhibitors or combination treatments.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 23 May 2024
- Start date
- 1 Feb 2022
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Miami Cancer Research Center, Inc.
- Diseases
- Thyroid cancer
- NCT number
- NCT06443866
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Feb 2022 to the primary completion date, 31 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cancers metastatic to thyroid
Age
- Age \< 18
Other
- Inability or unwillingness to give a written consent
- Life expectancy \< 3 months
- ECOG performance status ≥ 3
- Pregnant and nursing women.
Who the study is looking for
- Post-total thyroidectomy patients with diagnosis of thyroid cancer, any histology, subtype, any ATA risk category, for evaluation for residual disease, cervical or remote metastatic disease
- Patients with known or suspected recurrent/metastatic thyroid cancer, identified by ultrasound (US), CT/MR/FDG-PET\|CT or elevated thyroglobulin (Tg).
- Pretreatment and post-treatment evaluation of patients with thyroid cancer deemed RAI-indifferent/refractory who are considered for TKI
- Age ≥ 18
- Ability and willingness to give a written consent
- Life expectancy \> 3 months
- ECOG performance status ≤ 2
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Miami Cancer Research Center Coordinator of this site? Confirm its status | North Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.