Overview
Sponsor-declared trial summary
Lung Cancer
To measure the variability in tumor and organ uptake between two, closely obtained, [18F]F-AraG PET scans.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2026-01-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To measure the variability in tumor and organ uptake between two, closely obtained, [18F]F-AraG PET scans.
Conditions and MedDRA coding
Lung Cancer
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-522404-24-00 | Test-Retest Evaluation of [18F]F-AraG in Lung Tumors (TREAT) | Amsterdam UMC Stichting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Histologically confirmed lung cancer 2. At least 1 lesion with size of ≥2cm 3. Willing and able to provide written informed consent for the trial 4. Above 18 years of age on day of signing informed consent 5. Have measurable disease based on RECIST 1.1
Exclusion criteria 1
- 1. Patients on active immunomodulatory treatment 2. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 3. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 4. Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The absolute and relative difference in SUV and TBR uptake between both scanning timepoints
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB09188MIG · Substance
- Active substance
- Nelarabine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 204 MBq megabecquerel(s)
- Max total dose
- 204 MBq megabecquerel(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Modified into radiopharmaceutical tracer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Idris Bahce
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Idris Bahce
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 7 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Clinical Trial Protocol TREAT | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment procedures TREAT AUMC v1 07072025 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_participants TREAT AUMC | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | Not Applicable | 1 |
| Synopsis of the protocol (for publication) | D1_protocol synopsis Dutch TREAT 2025-522404-24-01 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-24 | Netherlands | Acceptable with conditions 2026-01-22
|
2026-01-27 |