18F-Fluorocholine PET/CT in Medullary Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT03643055|
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment|
|Medullary Thyroid Cancer||Diagnostic Test: 18F-fluorocholine PET/CT|
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).
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Diagnostic Value of 18F-Fluorocholine PET/CT for the Detection of Medullary Thyroid Cancer|
|Actual Study Start Date :||September 3, 2014|
|Estimated Primary Completion Date :||September 3, 2020|
|Estimated Study Completion Date :||September 3, 2024|
MTC 18F-fluorocholine PET/CT
Patients with medullary thyroid cancer imaged using 18F-fluorocholine PET/CT.
Diagnostic Test: 18F-fluorocholine PET/CT
18F-fluorocholine PET/CT imaging of the neck, mediastinum and whole body.
- Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy in primary medullary thyroid cancer [ Time Frame: 1 month ]Ability to detect primary medullary thyroid cancer (primary, nodal and metastatic lesions) in correlation with histopathological and/or conventional imaging data.
- Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy in recurrent medullary thyroid cancer [ Time Frame: 3 months ]Ability to detect recurrent medullary thyroid cancer (nodal and distant metastatic lesions) in correlation with histopathological and/or conventional imaging data.
- Survival analysis based on the initial PET/CT examination [ Time Frame: 5 years ]Survival analysis of the time to disease progression or disease recurrence after the initial PET/CT examination.
- Biochemical/clinical outcome - Ctn levels [ Time Frame: 5 years ]Normalization/stable elevation/increasing levels of serum Ctn.
- Biochemical/clinical outcome - CEA levels [ Time Frame: 5 years ]Normalization/stable elevation/increasing levels of serum CEA.
- Correlation between tumour metabolic activity and biochemical and histological markers [ Time Frame: 1 month ]Correlation of tumour metabolic activity with biochemical serum marker levels (Ctn, CEA) and tumour metabolic activity and histological quantitative indexes (eg Ki-67).
- Modification rate of patient's surgical and medical care after 18F-fluorocholine PET/CT [ Time Frame: 5 years ]Rate of patients whose management was modified based on the PET/CT imaging findings.
- Basic kinetic analysis of metabolic activity in the primary tumour, nodal and distant metastases. [ Time Frame: 3 months ]Ability to differentiate benign and malignant lesions using multiple-time-point imaging.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643055
|Contact: Luka Lezaicfirstname.lastname@example.org|
|Department for nuclear medicine, University medical centre Ljubljana||Recruiting|
|Ljubljana, Slovenia, 1000|
|Contact: Luka Lezaic, Md PhD +386 1 522 84 50 email@example.com|