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

May 29, 2024 updated by: Miami Cancer Research Center, Inc.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Keila Rios
  • Phone Number: 786-487-3230

Study Locations

  • United States
    • Florida
      • North Miami, Florida, United States, 33181
        • Recruiting
        • Miami Cancer Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (18 and older) with thyroid cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thyroid Cancer patients, RAI-naive or refractory
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification and characterization of RAI uptake pattern and kinetics
Time Frame: 5 years

Measurements:

  1. Administered activity
  2. Cumulated activity
  3. Standard uptake value

Calculations:

1. Radiation absorbed dose to the target

Correlations to be reported:

  1. Administered activity vs absorbed dose
  2. Absorbed dose vs response
  3. SUV at 48h vs response
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miami Cancer Research Center, Inc.

Investigators

  • Principal Investigator: Seza Gulec, MD, CEO, MCRC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTOCP03
  • MBK funding (Other Identifier: MiamiCancerRC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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