Overview
Sponsor-declared trial summary
Pheochromocytoma – endocrine adrenal tumor
The primary objective of this study is to assess the number of detected pheochromocytoma lesions, proved by histology, with [18F]mFBG PET-CT compared to the conventional CT.
Key facts
- Sponsor
- Universitair Medisch Centrum Utrecht
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-08-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513622-35-00
- EudraCT number
- 2020-005157-24
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Safety
The primary objective of this study is to assess the number of detected pheochromocytoma lesions, proved by histology, with [18F]mFBG PET-CT compared to the conventional CT.
Secondary objectives 1
- - To determine the optimal time point of [18F]mFBG PET-CT imaging via comparison of SUV values 1 and 2 hours on PET-CT imaging. - To correlate [18F]mFBG PET findings with pathology and immunohistochemistry analysis of norepinephrine transporter. - To estimate radiation dose of [18F]mFBG in normal tissues using dynamic PATLAK imaging. - To perform a safety analysis of [18F]mFBG administration on clinical symptoms by Adverse Events outcomes.
Conditions and MedDRA coding
Pheochromocytoma – endocrine adrenal tumor
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - The patient has provided written informed consent authorization before participating in the study. - The patient is ≥18 years of age at the time of consent. - The patient has a diagnosis of pheochromocytoma with a known anatomical location or laboratory findings suspicious for pheochromocytoma defined as elevated serum/plasma metanefrines. - The patient should have surgery planned. - The patient should have had a CT scan not older than 8 weeks at time of the [18F]mFBG PET-CT.. - The patient has an ECOG status of Grade 0 – 2.
Exclusion criteria 1
- - Patient is mentally or legally incapacitated. - Patient is pregnant or lactating. - Patient has active serious infections not controlled by antibiotics. - Patient is unable or unwilling to undergo PET-CT scanning or surgery. - Patient did receive interfering treatment between conventional CT scanning and [18F]mFBG PET-CT.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The number of detected pheochromocytoma lesions, proved by histology, with pathological [18F]mFBG uptake, defined as focal uptake above surrounding normal tissue, compared to number of lesions detected on protocollary conventional CT imaging prior to surgery.
Secondary endpoints 1
- 1)Optimal time point of [18F]mFBG PET-CT imaging via comparison of SUV values at 1 and 2 hours on PET-CT imaging. 2) Correlation of [18F]mFBG PET findings with pathology and immunohistochemistry analysis of norepinephrine transporter. 3) Estimation of radiation dose of [18F]mFBG in normal tissues using dynamic PATLAK imaging 4) Safety analysis of [18F]mFBG administration on clinical symptoms will be evaluated by Adverse Events outcomes
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
1-(3-(fluoro-18F)benzyl)guanidine ([18F]mFBG)
PRD11450421 · Product
- Active substance
- M-18F-FLUOROBENZYLGUANIDINE
- Substance synonyms
- [18F]meta-fluorobenzylguanidine, [18F]mFBG, Florbenguane (18F), IRP-101
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2 MBq/kg megabecquerel(s)/kilogram
- Max total dose
- 2 MBq/kg megabecquerel(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- UNIVERSITAIR MEDISCH CENTRUM UTRECHT
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/07/525
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Utrecht
- Sponsor organisation
- Universitair Medisch Centrum Utrecht
- Address
- Heidelberglaan 100
- City
- Utrecht
- Postcode
- 3584 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Dr. B. de Keizer
Public contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Dr. B. de Keizer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 10 | 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 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513622-35-00 For publication | 1.1 |
| Recruitment arrangements (for publication) | K1_blank document | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults_ For publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults_ Not for publication | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-15 | Netherlands | Acceptable with conditions 2024-08-05
|
2024-08-05 |