Iodine I 131 in Treating Patients With Thyroid Cancer

Not Applicable

Terminated

• Conditions: Head and Neck Cancer
• Interventions: Device: Patient-specific dosimetry

• Registration Number: NCT00416949
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

RATIONALE: Radioactive iodine kills thyroid cancer cells by giving off radiation.

PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I 131 works in treating patients with thyroid cancer.

Detailed Description

OBJECTIVES:

* Determine the relationship between estimated absorbed dose of iodine I 131 and tumor response or normal organ toxicity for different dosimetric measures, using data derived from clinical radionuclide therapy studies in patients with thyroid cancer.

OUTLINE: Patients receive oral dosimetric iodine I 131 (\^131I) on day 2 and then undergo nuclear medicine imaging at 0.5-4 hours, 24, 48, and 72 hours after dosimetric \^131I. Single-photon emission computed tomography (SPECT)/CT scans are performed at 0.5-4 hours and 24 or 48 hours over the head and neck region, including the salivary glands. Subsequent SPECT/CT scans are performed over the candidate tumor sites. Patients undergo \^131I therapy on day 11.

Saliva is collected on days 1 and 2, weeks 2 and 4, and months 3 and 6 to measure saliva flow rate. Blood is collected at baseline and periodically during study to measure FLT3 ligand levels.

PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-12-27
• Study First Submitted QC: 2006-12-27
• Study First Posted: 2006-12-28
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2017-05-02
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-22
• Last Update Submitted: 2018-06-22
• Results First Posted: 2018-07-18
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient-specific 3D-RD Dosimetry	Patient-specific dosimetry	Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.

Primary Outcome Measures

Name	Time	Method
Tumor Absorbed Dose	up to 4 years	Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States