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

NCT06443866 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-06-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Disease status detection

RAI dose determination

DIAGNOSTIC_TEST

Theranostic dosimetry

Theranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer

DRUG

I-124 PET/CT imaging

Theranostic dosimetry for optimization of RAI therapy for Thyroid Cancer

Sponsors & Collaborators

  • Miami Cancer Research Center, Inc.

    lead OTHER

Principal Investigators

  • Seza Gulec, MD · CEO, MCRC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2029-01-31
Completion
2029-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06443866 on ClinicalTrials.gov