Clinical trial NCT03643055: 18F-Fluorocholine PET/CT in Medullary Thyroid Cancer
Official title: Diagnostic Value of 18F-Fluorocholine PET/CT for the Detection of Medullary Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medullary Thyroid Cancer
Keywords: medullary thyroid cancer
imaging
hybrid-imaging
18F-choline
18F-fluorocholine
PET
PET/CT
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Institute of Oncology Ljubljana
First posted: 2018-08-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with medullary thyroid cancer treated at the Institute of Oncology Ljubljana.

Brief summary: To assess the diagnostic accuracy of 18F-Fluorocholine PET/CT for the detection of medullary thyroid cancer in patients with primary and recurrent disease.

Detailed description: Medullary thyroid cancer (MTC) is a relatively rare type of cancer that represents up to 10% of all primary thyroid cancers. It is a neuroendocrine tumour derived from parafollicular C-cells of the thyroid. It occurs either sporadically or in a hereditary form as a component of the type 2 multiple endocrine neoplasia (MEN) syndromes, MEN2A and MEN2B, and the related syndrome, familial MTC (FMTC).

Currently, the diagnosis of MTC is suspected based on the results of fine-needle aspiration (FNA) cytology, immunohistochemical analysis and elevated laboratory values of tumour markers calcitonin (Ctn) and carcinoembryonic antigen (CEA). According to the 2015 ATA guidelines, the preoperative imaging workup in all patients should include ultrasound examination of the neck; in selected patients, contrast-enhanced CT of the neck and chest, three-phase contrast-enhanced multi-detector liver CT, or contrast-enhanced MRI of the liver, and axial MRI and bone scintigraphy is also recommended. The curative therapy of choice is surgical removal of the tumour and/or metastases.

Nodal metastases are detected in 35-50% and distal metastases in about 15% of patients with primary MTC. Even with currently recommended diagnostic imaging techniques, about 50% of patients have persistent/recurrent disease after surgical treatment. This implies that currently available diagnostic imaging studies are suboptimal for accurate disease staging. New hybrid molecular imaging techniques based on SPECT/CT and especially PET/CT could improve disease detection by visualising pathophysiological processes in vivo. The most studied PET radiopharmaceutical for MTC imaging to date has been 18F-FDOPA, with recent studies focusing also on somatostatin receptor imaging using 68Ga-DOTATATE/TOC/NOC radiotracers.

18F-fluorocholine is a structural analogue of choline. It accumulates in cells with active membrane synthesis and overexpressed intracellular signal transduction, processes that are overactive in benign and malignant neoplasms. 18F-fluorocholine is currently primarily used for prostate cancer imaging. In contrast to radiotracers such as18F-fluorodeoxyglucose (18F-FDG), it is also taken up by well-differentiated neoplasms in which 18F-FDG uptake is unreliable. Similarly to 18F-FDG, 18F-fluorocholine is also known to accumulate in inflamed and infected tissue. However, this limitation could be overcome by performing multi-time-point imaging and using basic kinetic analysis. The working hypothesis is that 18F-fluorocholine might be efficiently taken up by primary MTC tumour as well as loco-regional and distant metastases.

The aim of the trial is to investigate the diagnostic accuracy of 18F-fluorocholine PET/CT in comparison to existing imaging modalities (US, CT and MRI).

Eligibility criteria: Inclusion Criteria:

* Patients with medullary thyroid cancer (sporadic or hereditary form).
* Patients with newly diagnosed MTC for primary staging (based on fine needle aspiration cytology results).
* Patients with suspicion of MTC recurrence for re-staging (based on biochemical, conventional imaging or clinical examination).
* Patients with metastatic MTC on systemic therapy for disease activity assessment.

Exclusion Criteria:

* Pregnancy.
* Patient with any PET/CT-scan exam contraindication (eg. severe claustrophobia).

Primary outcomes:
measure: Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy in primary medullary thyroid cancer
timeFrame: 1 month
measure: Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy in recurrent medullary thyroid cancer
timeFrame: 3 months
Secondary outcomes:
measure: Survival analysis based on the initial PET/CT examination
timeFrame: 5 years
measure: Biochemical/clinical outcome - Ctn levels
timeFrame: 5 years
measure: Biochemical/clinical outcome - CEA levels
timeFrame: 5 years
measure: Correlation between tumour metabolic activity and biochemical and histological markers
timeFrame: 1 month
measure: Modification rate of patient's surgical and medical care after 18F-fluorocholine PET/CT
timeFrame: 5 years
measure: Basic kinetic analysis of metabolic activity in the primary tumour, nodal and distant metastases.
timeFrame: 3 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Department for nuclear medicine, University medical centre Ljubljana
Study officials:
References: