Clinical Trial Finder

18F-Fluorocholine PET/CT in Medullary Thyroid Cancer

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
Unknown

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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).

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03643055

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
University Medical Centre Ljubljana

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
N/A
Principal Investigator Affiliation N/A

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOther
Overall Status Recruiting
Countries Slovenia

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Medullary Thyroid Cancer
Additional Details

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ljubljana, Slovenia

Status

Recruiting

Address

Department for nuclear medicine, University medical centre Ljubljana

Ljubljana, , 1000

Site Contact

Luka Lezaic, Md PhD

luka.lezaic@kclj.si

+386 1 522 84 50

The content provided by NBTS on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to: Terms, Conditions & Privacy