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NCT Number: NCT06443866

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

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.

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site RAI-Refractory Thyroid Cancer Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Miami Cancer Research Center

North Miami, Florida, 33181, United States

Location status: Recruiting

Location contact

Seza Gulec, MD

CONTACT

[email protected]

786-693-0821

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Disease status detection

Diagnostic Test

RAI dose determination

Theranostic dosimetry

Diagnostic Test

Theranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer

I-124 PET/CT imaging

Drug

Theranostic dosimetry for optimization of RAI therapy for Thyroid Cancer

Primary outcomes

  1. Identification and characterization of RAI uptake pattern and kinetics

    Time frame: 5 years

    Measurements:

    • Administered activity
    • Cumulated activity
    • Standard uptake value

    Calculations:

    • Radiation absorbed dose to the target

    Correlations to be reported:

    • Administered activity vs absorbed dose
    • Absorbed dose vs response
    • SUV at 48h vs response

Study contacts

Contact information is provided by the study sponsor or research team.

Keila Rios

CONTACT

786-487-3230

Seza Gulec, MD

CONTACT

[email protected]

786-693-0821

Sponsors and collaborators

Lead sponsor

Miami Cancer Research Center, Inc.

Other

Registry information

Official study title

CLINICAL UTILITY AND FEASIBILITY OF I-124 PET/CT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Jun 5, 2024
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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