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

NCT ID: NCT06028282

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-08

Study Completion Date

2025-06-08

Brief Summary

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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 \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\].

Detailed Description

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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.

Conditions

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Thyroid Disease

Keywords

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I-131

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Radioiodine I-131 (RAI)

oral administration of radioiodine I-131 (RAI) to patients with well-differentiated thyroid cancer

SPECT

Intervention Type RADIATION

SPECT of thyroid traced with I-131

Interventions

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SPECT

SPECT of thyroid traced with I-131

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York - Upstate Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Lubin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

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SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26462967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34519900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34703393 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20448022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23529347 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29858536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33808843 (View on PubMed)

Other Identifiers

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SUNYUMU 1642552

Identifier Type: -

Identifier Source: org_study_id