Post-RAI Therapy Dosimetry and Quality Assessment of Target Tissue Dosing (Varian)

The goal of this clinical trial study is to(1) determine the tissue specific dose of I-131 taken up by residing thyroid issue in the thyroid bed post-RAI along with any other sites in the neck and mediastinum as well as (2) correlate the dose delivered to residual tissues in the neck with patient follow-up based clinical outcomes, biochemical and imaging data following RAI therapy in patients with well-differentiated thyroid cancer (DTC). The main question[s] it aims to answer are:

• [question 1] How can obtained whole body and planar images more adequately depict residual iodine-avid disease in the thyroid bed, neck or mediastinum?
• [question 2] How can we obtain information on the dose taken up by the tumor remnant to know how much radionuclide actually went to the residual disease/tissue? Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items].

Study Overview

• Status: Enrolling by invitation
• Conditions: Thyroid Disease
• Intervention / Treatment: Radiation: SPECT

Detailed Description

In our current clinical practice, patients with well-differentiated thyroid cancer (DTC) who receive oral administration of radioiodine 1-131 (RAI) have whole body and planar images obtained 4-5 days post-treatment. These images often do not adequately depict residual iodine-avid disease in the thyroid bed, neck or mediastinum. Further, no information about what dose taken up by the tumor remnant is obtained and thus we are unable to know how much radionuclide actually went to the residual disease/tissue.

Using single photon emission computed tomography (SPECT)/CT we will be able to better localize and evaluate disease/tissue remnant or distant iodine-avid metastatic disease. In addition, using Varian Velocity Theranostics Dosimetry suite of software applications, we will be able to do dosimetry on post-RAI therapy patients and be able to better correlate clinical outcomes with tumor absorbed dose in addition to provide quality improvement for the radioiodine ablation.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Thyroid Disease

Description

Inclusion Criteria:

• All minorities
• 18 years of age and older
• Ability to give consent
• Male or female
• Differentiated thyroid cancer (DTC)
• Previous total thyroidectomy

• Has either:

  • local lymph node metastases
  • distant mediastinal/cervical metastases
  • lung or osseous metastases as seen on prior imaging studies

Exclusion Criteria:

• Non-iodine avid disease
• Under 18 years of age
• Unable to give consent
• Pregnant women, Non-viable neonates or neonates of uncertain viability.
• Non-English-speaking patients

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radioiodine I-131 (RAI); oral administration of radioiodine I-131 (RAI) to patients with well-differentiated thyroid cancer	Radiation: SPECT; SPECT of thyroid traced with I-131

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staging Accuracy and Improved Clinical Patient Care	In addition to providing a thorough evaluation for any iodine-avid disease in the thyroid bed, neck soft tissues and mediastinum, a SPECT/CT with a high-energy collimator will help better assess the clinical stage of disease at the time of RAI treatment. Thus, better staging accuracy will be obtained and this will improve clinical patient management	24 months

Collaborators and Investigators

• Sponsor: State University of New York - Upstate Medical University
• Investigators: Principal Investigator: David Lubin, MD, PhD, State University of New York - Upstate Medical University

Publications and helpful links

General Publications

• Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
• Willowson KP, Eslick EM, Bailey DL. Individualised dosimetry and safety of SIRT for intrahepatic cholangiocarcinoma. EJNMMI Phys. 2021 Sep 14;8(1):65. doi: 10.1186/s40658-021-00406-2.
• Lubin DJ, Tsetse C, Khorasani MS, Allahyari M, McGrath M. Clinical predictors of I-131 therapy failure in differentiated thyroid cancer by machine learning: A single-center experience. World J Nucl Med. 2021 Mar 15;20(3):253-259. doi: 10.4103/wjnm.WJNM_104_20. eCollection 2021 Jul-Sep.
• Lassmann M, Reiners C, Luster M. Dosimetry and thyroid cancer: the individual dosage of radioiodine. Endocr Relat Cancer. 2010 Jun 3;17(3):R161-72. doi: 10.1677/ERC-10-0071. Print 2010 Sep.
• Ferris HA, Williams G, Parker JA, Garber JR. Therapeutic implications of diffuse hepatic uptake following I-131 therapy for differentiated thyroid cancer. Endocr Pract. 2013 Mar-Apr;19(2):263-7. doi: 10.4158/EP12077.OR.
• Alan Selcuk N, Toklu T, Beykan S, Karaaslan SI. Evaluation of the dosimetry approaches in ablation treatment of thyroid cancer. J Appl Clin Med Phys. 2018 Jul;19(4):134-140. doi: 10.1002/acm2.12350. Epub 2018 Jun 1.
• de Koster EJ, Sulaiman T, Hamming JF, Schepers A, Snel M, van Velden FHP, de Geus-Oei LF, Vriens D. Radioiodine in Differentiated Thyroid Carcinoma: Do We Need Diagnostic Pre-Ablation Iodine-123 Scintigraphy to Optimize Treatment? Diagnostics (Basel). 2021 Mar 19;11(3):553. doi: 10.3390/diagnostics11030553.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Estimated): November 8, 2024
• Study Completion (Estimated): June 8, 2025

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: I-131
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: SUNYUMU 1642552

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data will be the only information available for sharing purposes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes