NCT00984191

Brief Summary

The purpose of this trial is to see if the 99mTechnetium-MIBI SPECT-CT can be a tool for preoperative evaluation of cervical node metastasis in papillary thyroid cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

1.6 years

First QC Date

September 24, 2009

Last Update Submit

June 23, 2011

Conditions

Papillary Thyroid Cancer

Keywords

Papillary thyroid cancer99mTechnetium MIBI SPECT CTpreoperativecervical lymphadenopathycervical metastasis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Tool Statistic (PPV , NPV , Sensitivity , Specificity , Accuracy )

    18 months

Study Arms (3)

99mTc positive

EXPERIMENTAL

99mTechnetium-MIBI SPECT-CT positive compare : Scan - Pathologic report

Radiation: 99mTc-MIBI SPECT-CT

99mTc Negative_Neck dissection

EXPERIMENTAL

99mTc Negative but have neck dissection indication compare : 99mTc - Pathologic report

Radiation: 99mTc-MIBI SPECT-CT

99mTc Negative_No neck dissection

EXPERIMENTAL

99mTc Negative and No other indication for neck dissection compare : 99mTc - 7. 131I (post-treatment) whole body scan

Radiation: 99mTc-MIBI SPECT-CT

Interventions

99mTc-MIBI SPECT-CTRADIATION

99mTc-MIBI SPECT-CT for abnormal cervical lymph node

99mTc Negative_Neck dissection99mTc Negative_No neck dissection99mTc positive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • papillary thyroid cancer

You may not qualify if:

  • pregnancy
  • Bleeding abnormality
  • Prior history of head and neck cancer
  • can not perform 99mTechnetium-MIBI SPECT-CT
  • can not perform 131I remnant Ablation
  • Prior any head and neck surgery within 3 months
  • Prior deep neck infection within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Hospital

Pathumwan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Napadon Tangjaturonrasme, Otolaryngologist

    Department of Otolaryngology , Faculty of Medicine , Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 24, 2009

First Posted

September 25, 2009

Study Start

March 1, 2010

Primary Completion

October 1, 2011

Study Completion

November 1, 2011

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

TH(1)