Evaluation of Thyroid Stunning From a Diagnostic Dose of I-123

NCT02278198 | Completed Phase 1 DMC

• 1 other identifier: 12-0300
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to find out if the small dose of radioiodine, that is used for the dosimetry study on patients with differentiated thyroid cancer, may stun the cancer cells and make the thyroid cancer treatment less effective.

Conditions

Differentiated Thyroid Cancer

Keywords

thyroid cancer

Outcome Measures

Primary Outcomes (1)

• Difference in uptake of I-123 in the thyroid remnant in the neck in the two imaging studies.

  Greater than a 20% decrease from the first to second study will indicate evidence of stunning.

  11 days

Study Arms (1)

Differentiated Thyroid Cancer

EXPERIMENTAL

All patients will receive one extra imaging scan with I-123 in addition to their routine care as described above. This research portion of their care will be similar to the scan that they undergo for the I-123 planning scan that is already a part of their routine care. The research study, which will be performed in the middle of the patient's normal standard of care treatment, will take 4 days. On days 1 and 2, all patients will receive a intramuscular injection of rhTSH (Thyrogen). On day 3, all patients will be given 3 mCi of I-123 in the form of a pill to take by mouth. On day 4, all patients will receive a I-123 Whole Body Imaging Scan and a thyroid camera scan of the neck and thigh.

Drug: rhTSH

Interventions

rhTSH DRUG

Intramuscular injections of rhTSH (Thyrogen) will be given on days 1 and 2.

Also known as: Thyrogen

Differentiated Thyroid Cancer

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be 21-years-old or greater.
• Patient must be status post near total thyroidectomy for differentiated thyroid cancer without known distant metastases and who are planning to undergo routine remnant thyroid tissue ablation with I-131.
• Patients must qualify for thyroid ablation with I-131.

You may not qualify if:

• Women who are pregnant or breastfeeding.
• Prior bovine TSH use.
• Known metastatic thyroid cancer.
• History of cardiovascular disease that may adversely affect patient participation at the discretion of the primary investigator.
• Patients on hemodialysis.
• Patients with acute serious illnesses at the discretion of the primary investigator.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Fawn N White

Denver, Colorado, 80211, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Thyrotropin Alfa

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Thyrotropin; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jennifer Kwak, MD

  Department of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 29, 2014
• Study Start: November 30, 2012
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: October 24, 2019

Record last verified: 2019-10

Locations

US (1)