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

C

Centre Francois Baclesse

Status

Completed

Conditions

Thyroid Gland

Treatments

Device: Radiation : PET-CT with F18-choline examination

Study type

Interventional

Funder types

Other

Identifiers

NCT02784223
CHOCOLATE

Details and patient eligibility

About

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.

Enrollment

107 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

107 participants in 1 patient group

PET-CT with F18-choline
Experimental group
Description:
PET-CT with F18-choline examination will be performed before surgery
Treatment:
Device: Radiation : PET-CT with F18-choline examination

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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