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

Status Enrolling by invitation

Clinical Trial Summary

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].

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06028282
Study type	Observational [Patient Registry]
Source	State University of New York - Upstate Medical University
Contact
Status	Enrolling by invitation
Phase
Start date	November 8, 2021
Completion date	June 8, 2025

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05836246` - The Development of Quantitative Ultrasound Imaging Software Platform
Active, not recruiting	`NCT05579782` - Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy	N/A
Completed	`NCT04124705` - A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants	Phase 2
Recruiting	`NCT05626010` - Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Thyroidectomy	N/A
Completed	`NCT01805856` - Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery	N/A
Completed	`NCT03640247` - Pain Medications Following Thyroidectomy and Parathyroidectomy	Phase 1
Recruiting	`NCT05117853` - Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Thyroidectomy	Phase 3
Completed	`NCT00592605` - Thyroid Disease Serum Repository	N/A
Completed	`NCT04344886` - Optimization and Individualization of Diagnostic Scintigraphy Protocol and Minimally Invasive Radio-guided Parathyroid Surgery	N/A
Completed	`NCT03012438` - NIRF for Parathyroid Visualization: a Pilot Study	N/A
Completed	`NCT00846755` - Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening	N/A
Completed	`NCT04635813` - The Impact of COVID-19 Pandemic on Thyroid Surgery in Italy: Results From a Nation-wide Multicentric Study
Not yet recruiting	`NCT05432050` - Bispectral Index and Patient State Index During General Anesthesia With Remimazolam
Recruiting	`NCT03191188` - A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients	N/A
Recruiting	`NCT06296420` - Dysphagia After Thyroidectomy
Completed	`NCT01539499` - Complications of Endocrine Surgery: Data From the United HealthSystem Consortium	N/A
Completed	`NCT02981095` - Effect of Bupivacaine Application on Postthyroidectomy Pain	N/A
Completed	`NCT05421559` - Transection of Sternothyroid Muscle Increases the Rate of Exposure of the External Laryngeal Nerve During Thyroidectomy	N/A
Completed	`NCT00054756` - Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients With Thyroid or Pituitary Abnormalities	Phase 2
Completed	`NCT02951000` - Platysma Trial - Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms