Clinical trial • Not applicable • Oncology|Other

SATOREOTIDE TRIZOXETAN GALLIUM (GA68) for Neuroblastoma

Not applicable trial of SATOREOTIDE TRIZOXETAN GALLIUM (GA68) for Neuroblastoma.

Overview

open-label, iobenguane (123i) - comparator; dose and schedule not specified-controlled Not applicable trial in Netherlands.

Recruits 20 paediatric patients.

Pregnancy Exclusion: pregnancy of the patient
Vulnerable Population: Pediatric population (age 0-18 years) selected as vulnerable. Consent must be provided in writing by the legal representative; assent must be obtained from the patient when applicable. Age-specific subject information and informed consent forms are provided (documents listed include L1_SIS and ICF_NL_Parents_Redacted, L1_SIS and ICF_NL_12-16eo_Redacted, L1_SIS and ICF_NL16eo_Redacted), indicating parent/legal representative ICFs and separate ICF/assent forms for older children/adolescents. Language versions available in the documentation are Dutch (Netherlands).

{"criterion_text":"- Age 0-18 years\n- Written informed consent (by legal representative) and assent consent from the patient when applicable\n- Patients with a clinical suspicion of neuroblastoma who are referred for the first time for conventional M123IBGimaging and patients with known NBL who are referred for for follow-up M123IBG imaging"}

{"criterion_text":"- Children with pre-existing severe auto-immune diseases.\n- Use of therapeutic long-acting somatostatin analogs (e.g. Sandostatin®, Lanreotide®) within the 21 days beforethe planned infusion of 68Ga-SATO\n- Use of diuretics within 24 hours before the planned infusion of 68Ga-SATO.\n- pregnancy of the patient"}

{"endpoint_text":"- To assess the short term safety and tolerability of 68Ga-SATO, according to CTCAE v5.0.","definition_or_measurement_approach":"Safety and tolerability assessed according to CTCAE v5.0."}

{"endpoint_text":"- Comparison of 68Ga-SATO PET/CT imaging to the current clinical standard of M123IBG scintigraphy in NBL patients, in terms of lesions detection.","definition_or_measurement_approach":"Absolute number of detected lesions and lesion localisation with 68Ga-SATO PET/CT compared to M123IBG scintigraphy."}
{"endpoint_text":"- Comparison of 68Ga-SATO PET/CT imaging to whole body MRI (in case available), in terms of lesions detection.","definition_or_measurement_approach":"Absolute number of detected lesions and lesion localisation with 68Ga-SATO PET/CT compared to whole body MRI (if available)."}
{"endpoint_text":"- To calculate, in a subset of patients, the radiation absorbed dose of 68Ga-SATO for patients using dynamic PET imaging.","definition_or_measurement_approach":"Calculation of whole-body and organ radiation absorbed dose using dynamic quantitative PET imaging in a subset of patients."}
{"endpoint_text":"- Evaluation of procedure time for the preparations and acquisition of a 68Ga-SATO","definition_or_measurement_approach":"Evaluation of procedure time from preparation/administration of 68Ga-SATO to end of PET image acquisition."}

Planned Sample Size: 20
Recruitment Window Months: 36
Consent Approach: Written informed consent must be provided by the legal representative; assent from the patient is required when applicable. Age-specific information and consent/assent forms are provided (documents include parent/legal representative ICF and separate ICF/assent versions for ages 12-16 and 16+). Materials available in Dutch (Netherlands) as per the listed SIS/ICF documents.

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