Recruiting

I-124 PET/CT Imaging

Sponsor:

Miami Cancer Research Center, Inc.

Code:

NCT06443866

Conditions

Thyroid Cancer

RAI-Refractory Thyroid Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Disease status detection

Theranostic dosimetry

I-124 PET/CT imaging

Study Details

Brief 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

Thyroid Cancer

RAI-Refractory Thyroid Cancer

Study ID

NCT06443866

Start date

Feb 1, 2022

Status verified date

May, 2024

Completion date

Dec, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Thyroid Cancer patients, RAI-naive or refractory

Interventions

Disease status detection

RAI dose determination

Theranostic dosimetry

Theranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer

I-124 PET/CT imaging

Theranostic dosimetry for optimization of RAI therapy for Thyroid Cancer

Primary outcome measure

  • Identification and characterization of RAI uptake pattern and kinetics [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

Miami Cancer Research Center

Recruiting

North Miami, Florida, United States, 33181

Contacts

More Information

Sponsor

Miami Cancer Research Center, Inc.

Last update posted

Jun 5, 2024

Last verified

May, 2024

Keywords

  • Thyroid Cancer
  • RAI-Refractory Thyroid Cancer
  • Redifferentiation Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Miami Cancer Research Center, Inc. on 2024-06-05.