Skip to main content
OpenTrials
Completed

NCT Number: NCT02784223

Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study

The purpose of the study is to investigate the contribution of PET-CT with F18-choline in the diagnosis of thyroid nodule with indeterminate cytology in order to guide the best indication of surgical resection.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thyroid Gland Endocrine System Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse

Caen, 14076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Patient with thyroid nodule ≥15 mm with an indeterminate cytology according to the Bethesda Classification 2008 (vesicular lesion of undetermined significance (Bethesda 3); follicular neoplasm or Hürthle cells (Bethesda 4); lesion suspicious for malignancy (Bethesda 5)), and to be operated on
  • Patient affiliated to a social security scheme
  • Informed consent and signed

Exclusion criteria

  • Thyroid nodules <15 mm
  • Coalescing nodules preventing proper individualization of targeted nodule;
  • Thyroid nodule with non-diagnostic cytology (Bethesda 1), benign cytology (Bethesda 2) or malignant cytology (Bethesda 6)
  • Hot thyroid nodule on the thyroid scan
  • Major subject to a measure of legal protection or unable to consent
  • Pregnant women / nursing
  • Refusal to participate

Treatment and study plan

Radiation : PET-CT with F18-choline examination

Device

PET-CT with F18-choline examination will be performed before surgery

Primary outcomes

  1. Sensitivity

    Time frame: Up to 4 months

    Sensitivity of 18F-choline PET to detect the cases of thyroid cancer among patients with thyroid nodule with an indeterminate cytology.

  2. Specificity

    Time frame: Up to 4 months

    Specificity of 18F-choline PET to detect the cases of thyroid cancer among patients with thyroid nodule with an indeterminate cytology.

Secondary outcomes

  1. Predictive diagnostic capabilities

    Time frame: Up to 4 months

    Diagnostic capabilities of 18F-Choline PET in predicting thyroid cancer

  2. Duration for acquisition

    Time frame: Up to 4 months

    Determination of the optimal duration for the PET acquisition.

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

  • Canceropôle Nord Ouest

Registry information

Acronym: CHOCOLATE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 27, 2016
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.