Status:
COMPLETED
FDG-PET/CT in Evaluation of Cytological Indeterminate Thyroid Nodules to Prevent Unnecessary Surgery (EfFECTS)
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Thyroid Nodule
Thyroid Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-needl...
Detailed Description
Rationale: Only about ¼ of patients with thyroid nodules with indeterminate cytology are proven to suffer from a malignancy at diagnostic hemithyroidectomy. Therefore \~¾ is operated upon unbeneficial...
Eligibility Criteria
Inclusion
- Documented history of a solitary thyroid nodule or a dominant nodule within multinodular disease, with (US-guided) FNAC performed by a dedicated radiologist or experienced endocrinologist or pathologist, demonstrating an indeterminate cytological examination (i.e. Bethesda category III or IV) according to the local pathologist and confirmed after central review;
- Scheduled for surgical excision (preferably) within 2 months of the inclusion date;
- Age ≥ 18 years;
- Euthyroid state with a serum thyrotropin (TSH) or a free T4 level within the institutional upper and lower limits of normal, measured within 2 months of registration. In case of a suppressed TSH: a negative 123I, 131I or 99mTcO4- scintigraphy must be available ("cold nodule");
- In patients with multinodular disease and a dominant nodule, the nuclear medicine physician responsible for FDG-PET/CT scan interpretation must determine whether the nodule is likely to be discriminated on FDG-PET/CT imaging prior to enrolment;
- Willing to participate in all aspects of the study;
Exclusion
- High a priori probability of malignancy:
- FNAC Bethesda category V or VI during local reading or central review;
- Prior radiation exposure / radiotherapy to the thyroid;
- Prior neck surgery or radiation that in the opinion of the PI has disrupted tissue architecture of the thyroid;
- New unexplained hoarseness, change of voice, stridor or paralysis of a vocal cord;
- In case a benign reason has been found (e.g. vocal cord edema), the patient is eligible;
- Thyroid nodule discovered as a FDG-PET positive incidentaloma
- New cervical lymphadenopathy highly suspicious for malignancy;
- In case malignancy is excluded, patient is eligible;
- Previous treatment for thyroid carcinoma or current diagnosis of any other malignancy that is known to metastasize to the thyroid;
- Known metastases of thyroid carcinoma;
- Known genetic predisposition for thyroid carcinoma:
- Familiar Non-Medullary Thyroid Cancer (NMTC)
- Familiar Papillary Thyroid Cancer (FPTC)
- Familiar Adenomatoid Polyposis Coli syndrome (FAP, Gardner syndrome, APC-gene mutations on chromosome 5q21)
- Morbus Cowden (PTEN mutation on chromosome 10q23.3)
- PTC / nodular thyroid hyperplasia / papillary renal tumours. Linked to locus 1q21.
- Proven benign disease or insufficient material for a cytological diagnosis:
- FNAC Bethesda category I or II during local reading or central review
- Performance of non-routine additional diagnostic tests that alter the patients treatment policy (e.g. mutation analysis on cytology)
- Inability to undergo randomization:
- Any patient that will receive thyroid surgery for other reasons (e.g. mechanical or cosmetic complaints).
- Inability to undergo treatment:
- Inability to undergo surgery in the opinion of the surgeon / anaesthetist.
- Contra-indications for FDG-PET/CT:
- Patient has evidence of infection localized to the neck in the 14 days prior to the FDG-PET/CT scan;
- Inability to tolerate lying supine for the duration of an FDG-PET/CT examination (\~10-15min);
- Poorly regulated diabetes mellitus (see next item);
- Hyperglycaemia at time of FDG injection prior to PET/CT (fasting serum glucose \>200mg/dL \[\>11.1 mmol/L\]);
- The use of short-acting insulins within 4 hours of the PET scan is not allowed
- If female and fertile: signs and symptoms of pregnancy or a positive pregnancy test / breast-feeding;
- A formal negative pregnancy test is not obligatory
- (severe) claustrophobia;
- Low dose benzodiazepines are allowed
- General contra-indications:
- Inability to give informed consent;
- Severe psychiatric disorder;
Key Trial Info
Start Date :
July 16 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT02208544
Start Date
July 16 2015
End Date
February 15 2022
Last Update
May 4 2022
Active Locations (15)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands
2
MUMC
Maastricht, Limburg, Netherlands
3
AMC
Amsterdam, North Holland, Netherlands
4
VUmc
Amsterdam, North Holland, Netherlands