Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
1
Head and neck squamous cell carcinoma, thyroid carcinoma
demonstrate uptake of [¹⁸F]AlF-PSMA-11 in lesions on PET.
Key facts
- Sponsor
- Universitair Ziekenhuis Gent
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Diseases [C] - Otorhinolaryngologic Diseases [C09], Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 1 Feb 2024 → ongoing
- Decision date (initial)
- 2023-08-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Ghent University Hospital · Kom op tegen Kanker (KOTK)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
demonstrate uptake of [¹⁸F]AlF-PSMA-11 in lesions on PET.
Secondary objectives 3
- compare lesion uptake of [¹⁸F]AlF-PSMA-11 to that of [¹⁸F]FDG on PET
- compare lesion uptake of [¹⁸F]AlF-PSMA-11 to that of radioiodine on thyroid scintigraphy
- assess biodistribution and organ-specific dosimetry analysis of [¹⁸F]AlF-PSMA-11 using PET
Conditions and MedDRA coding
Head and neck squamous cell carcinoma, thyroid carcinoma
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Proof-of-concept feasibility study monocentric, national, single-dose, phase II
prospective cohort trial, with two cohorts according to disease (tumour) type
|
Not Applicable | None | Cohort A: histological proof of HNSCC, disease in stage III–IVC, [¹⁸F]FDG PET available ≤ 2 months before inclusion, or planned ≤ 2 months after inclusion. Cohort B: histological proof of TC, metastatic disease (regional or distant metastases), [¹⁸F]FDG PET or thyroid scintigraphy available ≤ 2 months before inclusion, or planned ≤ 2 months after inclusion. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 18 years of age or older
- willing and mentally and legally capable of providing written informed consent
- have ≥ 1 measurable lesion of interest of ≥ 1.0 cm on medical imaging
Exclusion criteria 3
- potentially pregnant female patients refusing pregnancy testing at screening
- pregnant or breastfeeding female patients
- Patients with known hypersensitivity to the [¹⁸F]AlF-PSMA-11 or used excipients
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- qualitative count of lesions with significant [¹⁸F]AlF-PSMA-11 uptake on PET. For each subject, all endpoints are measured within 12 months after the last trial-specific intervention (trial-specific PET/CT or blood sampling) for that subject (LTIS). For the whole trial, all endpoints are measured within 12 months after the overall last trial-specific intervention (LTI), that is, after the last of all LTISs. (analyse PET images and blood and tissue samples until 12 months after the overall LTISs)
Secondary endpoints 2
- semiquantitative lesion radiotracer [¹⁸F]AlF-PSMA-11 uptake values on PET. For each subject, all endpoints are measured within 12 months after LTIS. For the whole trial, all endpoints are measured within 12 months after LTI.(analyse PET images and blood and tissue samples until 12 months after the overall LTISs)
- semiquantitative organ-level radiotracer [¹⁸F]AlF-PSMA-11 uptake values on PET. For each subject, all endpoints are measured within 12 months after LTIS. For the whole trial, all endpoints are measured within 12 months after LTI.(analyse PET images and blood and tissue samples until 12 months after the overall LTISs)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10247135 · Product
- Active substance
- Gozetotide ALF-18
- Substance synonyms
- AL(18F)PSMA-11, (AL18F)PSMA-HBED
- Other product name
- [18F]PSMA-HBED
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 4.4 MBq/kg megabecquerel(s)/kilogram
- Max total dose
- 4.4 MBq/kg megabecquerel(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- UNIVERSITAIR ZIEKENHUIS GENT
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Ziekenhuis Gent
- Sponsor organisation
- Universitair Ziekenhuis Gent
- Address
- Corneel Heymanslaan 10
- City
- Gent
- Postcode
- 9000
- Country
- Belgium
Scientific contact point
- Organisation
- Universitair Ziekenhuis Gent
- Contact name
- Michaël Henrotte
Public contact point
- Organisation
- Universitair Ziekenhuis Gent
- Contact name
- Michaël Henrotte
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 40 | 1 |
| 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 |
|---|---|---|---|---|---|
| Belgium | 2024-02-01 | 2024-03-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2022-503036-13-00 public | 3.0 |
| Protocol (for publication) | D2_ Risk Assessment Plan Study public | 1.0 |
| Protocol (for publication) | D2_Risk Analysis Matrix Study public | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF sponsor statement public | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material study emergency card public | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material study emergency card track-changes | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis 2022-503036-13-00 public | 3.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-25 | Belgium | Acceptable with conditions 2023-08-11
|
2023-08-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-14 | Belgium | Acceptable with conditions 2023-08-11
|
2023-09-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-06 | Belgium | Acceptable with conditions 2023-08-11
|
2024-12-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-28 | Belgium | Acceptable 2025-10-07
|
2025-10-07 |