Medullary Thyroid CancerNCT03643055
18F-Fluorocholine PET/CT in Medullary Thyroid Cancer
An observational study of Medullary Thyroid Cancer, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medullary Thyroid Cancer
- What is being tested?
- 18F-fluorocholine PET/CT
- How many people
- 80 participants
- Where
- 1 siteSlovenia
- Study dates
- 3 Sep 2014to 3 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with medullary thyroid cancer treated at the Institute of Oncology Ljubljana.
Who may be able to join
- 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.
Who cannot join
- Pregnancy.
- Patient with any PET/CT-scan exam contraindication (eg. severe claustrophobia).
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Department for nuclear medicine, University medical centre Ljubljana
Ljubljana, 1000
About this study
Official title: Diagnostic Value of 18F-Fluorocholine PET/CT for the Detection of Medullary Thyroid Cancer
To assess the diagnostic accuracy of 18F-Fluorocholine PET/CT for the detection of medullary thyroid cancer in patients with primary and recurrent disease.
Read the 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).
- Conditions
- Medullary Thyroid Cancer
- Being tested
- 18F-fluorocholine PET/CT
- Keywords
- medullary thyroid cancer, imaging, hybrid-imaging, 18F-choline, 18F-fluorocholine, PET, PET/CT
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluorocholine PET/CTDiagnostic test
18F-fluorocholine PET/CT imaging of the neck, mediastinum and whole body.
| Study group | Role | What they receive |
|---|---|---|
| MTC 18F-fluorocholine PET/CT | Patients with medullary thyroid cancer imaged using 18F-fluorocholine PET/CT. Receives: Diagnostic Test: 18F-fluorocholine PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy in primary medullary thyroid cancer
Ability to detect primary medullary thyroid cancer (primary, nodal and metastatic lesions) in correlation with histopathological and/or conventional imaging data.
Measured: 1 month
Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy in recurrent medullary thyroid cancer
Ability to detect recurrent medullary thyroid cancer (nodal and distant metastatic lesions) in correlation with histopathological and/or conventional imaging data.
Measured: 3 months
Secondary outcomes (6)
Survival analysis based on the initial PET/CT examination
Survival analysis of the time to disease progression or disease recurrence after the initial PET/CT examination.
Measured: 5 years
Biochemical/clinical outcome - Ctn levels
Normalization/stable elevation/increasing levels of serum Ctn.
Measured: 5 years
Biochemical/clinical outcome - CEA levels
Normalization/stable elevation/increasing levels of serum CEA.
Measured: 5 years
Correlation between tumour metabolic activity and biochemical and histological markers
Correlation of tumour metabolic activity with biochemical serum marker levels (Ctn, CEA) and tumour metabolic activity and histological quantitative indexes (eg Ki-67).
Measured: 1 month
Modification rate of patient's surgical and medical care after 18F-fluorocholine PET/CT
Rate of patients whose management was modified based on the PET/CT imaging findings.
Measured: 5 years
Basic kinetic analysis of metabolic activity in the primary tumour, nodal and distant metastases.
Ability to differentiate benign and malignant lesions using multiple-time-point imaging.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start3 Sep 2014
- Primary completion3 Mar 2021 (estimated)
- Study completion3 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medullary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Oncology Ljubljana
- Responsible party
- Principal investigator, Luka Lezaic MD PhD, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643055
- Sponsor's protocol ID
- 92/08/14
- Status last verified
- Nov 2020
- First submitted
- 20 Aug 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of 18F-Fluorocholine PET/CT for the Detection of Medullary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT03643055
- Acronym / sponsor ID
- 92/08/14
- Conditions
- Medullary Thyroid Cancer
- Keywords
- medullary thyroid cancer, imaging, hybrid-imaging, 18F-choline, 18F-fluorocholine, PET, PET/CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Institute of Oncology Ljubljana
- Study start
- 3 Sep 2014 (actual)
- Primary completion
- 3 Mar 2021 (estimated)
- Study completion
- 3 Sep 2024 (estimated)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MTC 18F-fluorocholine PET/CT | – | Diagnostic Test: 18F-fluorocholine PET/CTPatients with medullary thyroid cancer imaged using 18F-fluorocholine PET/CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with medullary thyroid cancer treated at the Institute of Oncology Ljubljana.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnancy.
- Patient with any PET/CT-scan exam contraindication (eg. severe claustrophobia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-fluorocholine PET/CT18F-fluorocholine PET/CT imaging of the neck, mediastinum and whole body. | Diagnostic test | MTC 18F-fluorocholine PET/CT |
Primary outcome
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.
6 secondary outcomes
Survival analysis based on the initial PET/CT examination
Time frame: 5 years
Biochemical/clinical outcome - Ctn levels
Time frame: 5 years
Biochemical/clinical outcome - CEA levels
Time frame: 5 years
Correlation between tumour metabolic activity and biochemical and histological markers
Time frame: 1 month
Modification rate of patient's surgical and medical care after 18F-fluorocholine PET/CT
Time frame: 5 years
Basic kinetic analysis of metabolic activity in the primary tumour, nodal and distant metastases.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medullary Thyroid Cancer, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy in primary medullary thyroid cancer (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.