Overview
Sponsor-declared trial summary
Differentiated Thyroid Cancer
a) To determine the optimal time point acquisition of [18F]TFB PET/CT, b) to determine the value of [18F]TFB PET/CT for detection of (pre-operative) metastatic lymph node(s) in patients with differentiated thyroid cancer and c) to determine the value of [18F]TFB PET/CT for the estimation of radioiodine therapy response…
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Sep 2025 → ongoing
- Decision date (initial)
- 2025-04-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- KWF
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
a) To determine the optimal time point acquisition of [18F]TFB PET/CT, b) to determine the value of [18F]TFB PET/CT for detection of (pre-operative) metastatic lymph node(s) in patients with differentiated thyroid cancer and c)
to determine the value of [18F]TFB PET/CT for the estimation of radioiodine therapy response in patients with persistent and recurrent differentiated thyroid cancer.
Secondary objectives 1
- - To study [18F]TFB kinetics in normal thyroid tissue, in primary thyroid tumor tissue, in lymph node metastases and in distant metastases (SUVmax, tumor-to-background ratio). - To analyse the possible correlation between [18F]TFB uptake and NIS-membrane expression levels, as determined by immunohistochemistry. - To assess whether [18F]TFB PET/CT might be advisable especially for patients with minimally elevated tumor marker levels.
Conditions and MedDRA coding
Differentiated Thyroid Cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Group 1: patients with newly diagnosed differentiated thyroid cancer and pathologically proven lymph node metastases thyroid cancer referred for surgical resection - Group 2: patients with differentiated thyroid cancer referred for 131I therapy - The patient has provided written informed consent authorization before participating in the study - The patient is ≥ 18 years old - The patient has an ECOG status grade 0-2
Exclusion criteria 1
- - Patient is mentally or legally incapacitated - Patient is pregnant or lactating - Patient has been subjected to an excess of substrates of the sodium iodine symporter such as iodine (e.g. in the form of iodinated contrast agent) or perchlorate within the past 2 months. - Patient takes lithium - Patient takes amiodarone
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Optimal time kinetic point and number and localization of lymph node metastases + predictive 131I therapy response
- Analysis of reference standards: ultrasonography, pathology and post-therapy 131I scan (these tests are performed under regular clinical care)
Secondary endpoints 1
- To study [18F]TFB kinetics in normal thyroid tissue, in primary thyroid tumor tissue, in lymph node metastases and in distant metastases (SUVmax, tumorto-background ratio). - To analyse the possible correlation between [18F]TFB uptake and NISmembrane expression levels, as determined by immunohistochemistry. - To assess whether [18F]TFB PET/CT might be advisable especially for patients with minimally elevated tumor marker levels.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11753529 · Product
- Active substance
- Tetrafluoroborate Ion F-18
- Substance synonyms
- TBF F-18 anion
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 2 GBq/Kg gigabecquerel/kilogram
- Max total dose
- 2 GBq/Kg gigabecquerel/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ERASMUS MC
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Prof. dr. Frederik Verburg
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Prof. dr. Frederik Verburg
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 40 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2025-09-01 | 2026-04-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516025-30-00 | 3 |
| Protocol (for publication) | D1_Protocol 2024-516025-30-00 - Tracked Changes | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Tracked Changes | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-516025-30-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-03 | Netherlands | Acceptable with conditions 2025-04-02
|
2025-04-02 |