Clinical trial NCT06443866: I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer
Official title: CLINICAL UTILITY AND FEASIBILITY OF I-124 PET/CT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Cancer
RAI-Refractory Thyroid Cancer
Keywords: Thyroid Cancer
RAI-Refractory Thyroid Cancer
Redifferentiation Therapy
Lead sponsor: Miami Cancer Research Center, Inc.
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (18 and older) with thyroid cancer

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Identification and characterization of RAI uptake pattern and kinetics
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: North Miami
country: United States
facility: Miami Cancer Research Center
state: Florida
Study officials:
affiliation: CEO, MCRC
name: Seza Gulec, MD
role: PRINCIPAL_INVESTIGATOR
References: