Overview
Sponsor-declared trial summary
Cancer patients with brain metastasis
To compare the uptake of 68GaNOTA-Anti-HER2 VHH1 in brain metastasis lesions from HER2-positive and HER2-negative patients
Key facts
- Sponsor
- Universitair Ziekenhuis Brussel
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 16 Oct 2017 → 14 Oct 2025
- Decision date (initial)
- 2024-07-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513997-23-00
- EudraCT number
- 2015-002328-24
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis
To compare the uptake of 68GaNOTA-Anti-HER2 VHH1 in brain metastasis lesions from HER2-positive and HER2-negative patients
Conditions and MedDRA coding
Cancer patients with brain metastasis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients who have given informed consent
- Age 18 years or older patients with brain metastasized cancer, with at least 1 brain lesion of at least 8 mm maximal diameter, as measured by CT or MRI
- Patients with potentially HER2-positive cancer. Either a HER2 staining should have been done in standard of care, or sufficient tissue should be available for HER2-staining for study purpose
Exclusion criteria 7
- Pregnant patients
- Breast feeding patients
- Patients with recent (< 1 week) gastrointestinal disorders with diarrhea as major symptom
- Patients with any serious active infection
- Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the test radiopharmaceutical
- Patients who cannot communicate reliably with the investigator
- Patients at increased risk of death from a pre-existing concurrent illness
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- The tumor targeting potential in brain metastasis will be visually scored as positive or negative by an experienced nuclear medicine physician, unaware of the HER2-status
- The tumor targeting potential in brain metastasis will be assessed quantitatively using Standard Uptake Values (SUV) by an experienced nuclear medicine physician, unaware of the HER2-status.
Secondary endpoints 1
- If available, uptake will be evaluated during and after treatment and compared to baseline values. Results will be compared to information of patient's disease course.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11160902 · Product
- Active substance
- 68GANOTA-ANTI-HER2 VHH1
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 185 MBq megabecquerel(s)
- Max total dose
- 185 MBq megabecquerel(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- UZ BRUSSEL
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Ziekenhuis Brussel
- Sponsor organisation
- Universitair Ziekenhuis Brussel
- Address
- Laarbeeklaan 101
- City
- Jette
- Postcode
- 1090
- Country
- Belgium
Scientific contact point
- Organisation
- Universitair Ziekenhuis Brussel
- Contact name
- Prof. Dr. Tony Lahoutte
Public contact point
- Organisation
- Universitair Ziekenhuis Brussel
- Contact name
- Prof. Dr. Tony Lahoutte
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 30 | 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 | 2017-10-16 | 2017-10-16 | 2025-10-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol _2024-513997-23-00 | 6.1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1.0 |
| Subject information and informed consent form (for publication) | Main ICF_FR_2024-513997-23-00 | 3.1 |
| Subject information and informed consent form (for publication) | Main ICF_NL_2024-513997-23-00 | 3.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-18 | Belgium | Acceptable with conditions 2024-07-30
|
2024-07-30 |