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Trial record 7 of 116 for:    medullary carcinoma

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
Sponsor:
Collaborator:
Institute of Oncology Ljubljana
Information provided by (Responsible Party):
Luka Lezaic MD PhD, University Medical Centre 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.

Condition or disease Intervention/treatment
Medullary Thyroid Cancer Diagnostic Test: 18F-fluorocholine PET/CT

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).


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Biochemical/clinical outcome - Ctn levels [ Time Frame: 5 years ]
    Normalization/stable elevation/increasing levels of serum Ctn.

  3. Biochemical/clinical outcome - CEA levels [ Time Frame: 5 years ]
    Normalization/stable elevation/increasing levels of serum CEA.

  4. 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).

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with medullary thyroid cancer treated at the Institute of Oncology Ljubljana.
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).

Information from the National Library of Medicine

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


Contacts
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Contact: Luka Lezaic +38641334067 lukalezaic@gmail.com

Locations
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Slovenia
Department for nuclear medicine, University medical centre Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Luka Lezaic, Md PhD    +386 1 522 84 50    luka.lezaic@kclj.si   
Sponsors and Collaborators
University Medical Centre Ljubljana
Institute of Oncology Ljubljana

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Responsible Party: Luka Lezaic MD PhD, Principal Investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03643055     History of Changes
Other Study ID Numbers: 92/08/14
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luka Lezaic MD PhD, University Medical Centre Ljubljana:
medullary thyroid cancer
imaging
hybrid-imaging
18F-choline
18F-fluorocholine
PET
PET/CT
Additional relevant MeSH terms:
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Carcinoma, Neuroendocrine
Carcinoma
Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents