Clinical trial • Not applicable • Oncology|Rare Disease|Other

[18F]META-FLUOROBENZYLGUANIDINE for Neuroblastoma

Not applicable trial of [18F]META-FLUOROBENZYLGUANIDINE for Neuroblastoma.

Overview

Trial Therapeutic Area
Oncology|Rare Disease|Other
Trial Disease
Neuroblastoma
Trial Stage
Not applicable
Drug Modality
Radiopharmaceutical
Paediatric Trial
Yes
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
27-06-2024
First CTIS Authorization Date
23-09-2024

Trial design

IOBENGUANE (123I) ([123I]mIBG) conventional SPECT-CT imaging (comparator imaging modality). No dose or schedule specified in the record.-controlled Not applicable trial across 1 site in Netherlands.

Comparator
IOBENGUANE (123I) ([123I]mIBG) conventional SPECT-CT imaging (comparator imaging modality). No dose or schedule specified in the record.
Target Sample Size
58

Eligibility

Recruits 58 paediatric patients.

Pregnancy Exclusion
Pregnancy of patient
Vulnerable Population
Includes vulnerable population (children/minors). Written informed consent must be obtained from patients and/or from parents or legal guardians according to local law and regulations. Age-specific subject information and informed consent forms are provided (documents listed for '16 yr and older', '12-16 yr', and parent/guardian versions).

Inclusion criteria

  • {"criterion_text":"- Patient with (a clinical suspicion of) neuroblastoma who is referred for conventional [123I]mIBG imaging"}
  • {"criterion_text":"- Written informed consent from patients and/or from parents or legal guardians, according to local law and regulations"}

Exclusion criteria

  • {"criterion_text":"- [18F]mFBG imaging cannot be scheduled within two weeks of [123I]mIBG imaging"}
  • {"criterion_text":"- Pregnancy of patient"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Detected skeletal lesions on [18F]mFBG PET-CT and [123I]mIBG scanning","definition_or_measurement_approach":"Comparison of diagnostic performance of [18F]mFBG PET-CT versus conventional [123I]mIBG SPECT-CT for detection of skeletal lesions (as stated in main objective)."}

Secondary endpoints

  • {"endpoint_text":"- Detected soft tissue lesions on [18F]mFBG and [123I]mIBG scanning","definition_or_measurement_approach":"Comparison of diagnostic performance of [18F]mFBG PET-CT versus [123I]mIBG SPECT-CT for detection of soft tissue lesions."}
  • {"endpoint_text":"- Radiation absorbed doses (mSv) for organs and tumour of [18F]mFBG imaging","definition_or_measurement_approach":"Calculated absorbed radiation dose of [18F]mFBG in normal organs and tumour lesions in a subset of patients undergoing dynamic PET scanning."}
  • {"endpoint_text":"- Mean difference in number of detected lesions and limits of agreement, Cohen’s kappa","definition_or_measurement_approach":"Statistical comparison of lesion counts between modalities, including limits of agreement and Cohen's kappa for interobserver agreement."}
  • {"endpoint_text":"- SUVmean for normal organs, SUVmax for tumour lesions","definition_or_measurement_approach":"Quantitative image uptake metrics (SUVmean for normal organs; SUVmax for tumour lesions) measured on [18F]mFBG PET-CT."}

Recruitment

Planned Sample Size
58
Recruitment Window Months
37
Consent Approach
Written informed consent from patients and/or from parents or legal guardians according to local law and regulations. Age-specific subject information and informed consent forms are available (documents for '16 yr and older', '12-16 yr', and parent/guardian versions). Documents available in Dutch (NL) as per provided SIS/ICF filenames.

Geography

Total Number Of Sites
1
Total Number Of Participants
58

Netherlands

Earliest CTIS Part Ii Submission Date
21-08-2024
Latest Decision Or Authorization Date
23-09-2024
Processing Time Days
33
Number Of Sites
1
Number Of Participants
58

Sites

Site Name
Princess Maxima Center For Pediatric Oncology
Department Name
Solid Tumors
Principal Investigator Name
Lieve Tytgat
Principal Investigator Email
g.a.m.tytgat@prinsesmaximacentrum.nl
Contact Person Name
Lieve Tytgat
Number Of Participants
58

Sponsor

Primary sponsor

Full Name
Princess Maxima Center For Pediatric Oncology
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Third parties

  • {"country":"","full_name":"KiKa (Foundation)","duties_or_roles":"Monetary support","organisation_type":""}

Investigational products

Investigational Product Name
[18F]meta-fluorobenzylguanidine
Active Substance
[18F]META-FLUOROBENZYLGUANIDINE
Modality
Radiopharmaceutical
Routes Of Administration
SOLUTION FOR INJECTION
Route
Solution for injection
Orphan Designation
Yes
Investigational Product Name
IOBENGUANE (123I)
Active Substance
IODINE (123I) IOBENGUANE
Modality
Radiopharmaceutical
Routes Of Administration
SOLUTION FOR INJECTION
Route
Solution for injection
Authorisation Status
Authorised (SmPC document available)
Orphan Designation
Yes

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