I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer

NCT ID: NCT06443866

Last Updated: 2024-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thyroid Cancer RAI-Refractory Thyroid Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Thyroid Cancer patients, RAI-naive or refractory

Disease status detection

Intervention Type DIAGNOSTIC_TEST

RAI dose determination

Theranostic dosimetry

Intervention Type DIAGNOSTIC_TEST

Theranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer

I-124 PET/CT imaging

Intervention Type DRUG

Theranostic dosimetry for optimization of RAI therapy for Thyroid Cancer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Disease status detection

RAI dose determination

Intervention Type DIAGNOSTIC_TEST

Theranostic dosimetry

Theranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer

Intervention Type DIAGNOSTIC_TEST

I-124 PET/CT imaging

Theranostic dosimetry for optimization of RAI therapy for Thyroid Cancer

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Cancers metastatic to thyroid
* Age \< 18
* Inability or unwillingness to give a written consent
* Life expectancy \< 3 months
* ECOG performance status ≥ 3
* Pregnant and nursing women.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Miami Cancer Research Center, Inc.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Seza Gulec, MD

Role: PRINCIPAL_INVESTIGATOR

CEO, MCRC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Miami Cancer Research Center

North Miami, Florida, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Seza Gulec, MD

Role: CONTACT

786-693-0821

Keila Rios

Role: CONTACT

786-487-3230

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Seza Gulec, MD

Role: primary

786-693-0821

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MBK funding

Identifier Type: OTHER

Identifier Source: secondary_id

MTOCP03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PET-TC in Thyroid Evaluation
NCT06852144 ENROLLING_BY_INVITATION