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FDG-PET/CT in Evaluation of Cytological Indeterminate Thyroid Nodules to Prevent Unnecessary Surgery (EfFECTS)

NCT02208544 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2022-05-04

No results posted yet for this study

Summary

The purpose of this study is to determine whether the use of molecular imaging using FDG-PET/CT could prevent unnecessary diagnostic thyroid surgery in case of indeterminate cytology during fine-needle aspiration biopsy.

Conditions

  • Thyroid Nodule
  • Thyroid Neoplasms

Interventions

PROCEDURE

Diagnostic Thyroid Surgery

Diagnostic Thyroid Surgery

DEVICE

Ultrasound of the head and neck

Confirmatory Neck Ultrasonography in FDG-PET/CT negative patient in the experimental arm

RADIATION

FDG-PET/CT

Head and Neck FDG-PET/CT

Sponsors & Collaborators

  • Dutch Cancer Society

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Lioe-Fee de Geus-Oei, MD, PhD · Leiden University Medical Center, Leiden, the Netherlands

  • Dennis Vriens, MD, PhD · Leiden University Medical Center, Leiden, the Netherlands

  • Lisanne de Koster, MD · Radboud University Medical Centre, Nijmegen, the Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-16
Primary Completion
2020-01-01
Completion
2022-02-15

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02208544 on ClinicalTrials.gov