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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Miami Cancer Research Center
RECRUITING
North Miami
Contact Information
Primary
Seza Gulec, MD
sezagulec@gmail.com
786-693-0821
Backup
Keila Rios
786-487-3230
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2029-12
Participants
Target number of participants: 50
Treatments
Thyroid Cancer patients, RAI-naive or refractory
Related Therapeutic Areas
Sponsors
Leads: Miami Cancer Research Center, Inc.

This content was sourced from clinicaltrials.gov