18F-Fluorocholine PET/CT in Medullary Thyroid Cancer

NCT03643055 | Unknown

• 1 other identifier: 92/08/14
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Medullary Thyroid Cancer

Keywords

medullary thyroid cancer; imaging; hybrid-imaging; 18F-choline; 18F-fluorocholine; PET; PET/CT

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 months

Secondary Outcomes (6)

• Survival analysis based on the initial PET/CT examination

  5 years

• Biochemical/clinical outcome - Ctn levels

  5 years

• Biochemical/clinical outcome - CEA levels

  5 years

• Correlation between tumour metabolic activity and biochemical and histological markers

  1 month

• Modification rate of patient's surgical and medical care after 18F-fluorocholine PET/CT

  5 years

Study Arms (1)

MTC 18F-fluorocholine PET/CT

Patients with medullary thyroid cancer imaged using 18F-fluorocholine PET/CT.

Diagnostic Test: 18F-fluorocholine PET/CT

Interventions

18F-fluorocholine PET/CT DIAGNOSTIC_TEST

18F-fluorocholine PET/CT imaging of the neck, mediastinum and whole body.

MTC 18F-fluorocholine PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with medullary thyroid cancer treated at the Institute of Oncology Ljubljana.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Institute of Oncology Ljubljana: collaborator

Study Sites (1)

Department for nuclear medicine, University medical centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Carcinoma, Medullary

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: September 3, 2014
• Primary Completion: March 3, 2021
• Study Completion: September 3, 2024
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

SL (1)