NCT00416949

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
8.8 years until next milestone

Results Posted

Study results publicly available

July 18, 2018

Completed
Last Updated

July 18, 2018

Status Verified

June 1, 2018

Enrollment Period

3.5 years

First QC Date

December 27, 2006

Results QC Date

May 2, 2017

Last Update Submit

June 22, 2018

Conditions

Head and Neck Cancer

Keywords

anaplastic thyroid cancerinsular thyroid cancerthyroid gland medullary carcinomarecurrent thyroid cancerstage I follicular thyroid cancerstage I papillary thyroid cancerstage II follicular thyroid cancerstage II papillary thyroid cancerstage III follicular thyroid cancerstage III papillary thyroid cancerstage IVA follicular thyroid cancerstage IVB follicular thyroid cancerstage IVC follicular thyroid cancerstage IVA papillary thyroid cancerstage IVB papillary thyroid cancerstage IVC papillary thyroid cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor Absorbed Dose

    Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.

    up to 4 years

Study Arms (1)

Patient-specific 3D-RD Dosimetry

EXPERIMENTAL

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

Device: Patient-specific dosimetry

Interventions

Patient-specific dosimetryDEVICE

Patient-specific 3D-RD dosimetry was applied to the data collected

Patient-specific 3D-RD Dosimetry

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of thyroid cancer * Measurable disease by CT scan or nuclear medicine imaging * Eligible, by standard of care criteria, for iodine I 131 therapy PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective non-barrier method contraception (e.g., combined or progesterone-only oral contraceptive pill, intrauterine device, depot progesterone, or stable relationship with a partner who has had a vasectomy) * No other malignancy within the past 5 years except squamous cell or basal cell carcinoma of the skin * No nonthyroidal conditions known to affect iodine I 131 uptake (e.g., New York Heart Association class III or IV congestive heart failure or renal failure) * No alcoholism or drug abuse within the past 2 years * No severe emotional, behavioral, or psychiatric problems that would preclude study compliance (e.g., severe claustrophobia) PRIOR CONCURRENT THERAPY: * No intravenous water-soluble radiographic contrast within the past 4 weeks * No iodinated contrast agent within the past 3 months * No concurrent drugs that may affect thyroid or renal function (e.g., renal drugs, lithium, amiodarone, other iodine-containing medication, or corticosteroids) * No other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsThyroid Carcinoma, AnaplasticCarcinoma, MedullaryThyroid NeoplasmsAdenocarcinoma, FollicularThyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalAdenocarcinomaNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve TissueEndocrine Gland NeoplasmsEndocrine System DiseasesThyroid DiseasesAdenocarcinoma, Papillary

Limitations and Caveats

The protocol was designed for data collection with minimal impact on treatment. Data collection was terminated due to low accrual . No reportable results could be obtained.

Results Point of Contact

Title
George Sgouros
Organization
SKCCC
gsgouros@jhmi.edu
4106140116

Study Officials

  • George Sgouros, PhD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2006

First Posted

December 28, 2006

Study Start

April 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

July 18, 2018

Results First Posted

July 18, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)