68Ga-DOTATATE Neuroblastoma Imaging Pilot
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|ClinicalTrials.gov Identifier: NCT04559217|
Recruitment Status : Not yet recruiting
First Posted : September 22, 2020
Last Update Posted : September 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Biological: Radiopharmaceutical 68Ga-DOTATATE||Phase 2|
Background: Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Initial staging of the disease and monitoring of the treatment response can be performed with different imaging modalities that include contrast-enhanced computed tomography (ceCT), ultrasound, magnetic resonance imaging (MRI), bone scintigraphy and 123I-MIBG scintigraphy.
Another potential target for neuroblastoma imaging is the somatostatin receptor (SSTR) that is present in many neuroendocrine tumours (NET). The superior PET imaging technology used with new radiotracers (such as 68Ga-DOTATATE) enables imaging at advantageous resolutions well below what is possible by current clinical SPECT systems that are used for 123I-MIBG.
Design: Prospective single-arm non-randomized clinical trial (phase II) - pilot
Objective: 1) Assess the feasibility and safety of 68Ga-DOTATATE PET/CT imaging in patients with neuroblastoma or suspected of having neuroblastoma. 2) Compare lesion-by-lesion the uptake of 68Ga-DOTATATE and 123I-MIBG in the same participant.
Study population: Children and adults with biopsy-proven or suspected neuroblastoma
Procedure and Follow-up: Few days after 123I-MIBG scan, participants will undergo a 68Ga-DOTA-cTATE PET/CT scan (duration 2 hours). Clinical data will be collected from this imaging and from the participant's medical record (demographic, treatment, medication, pathology, lab test results) for a 2-year follow-up period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective pilot study|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma|
|Estimated Study Start Date :||November 15, 2020|
|Estimated Primary Completion Date :||November 15, 2026|
|Estimated Study Completion Date :||August 30, 2027|
Experimental: Single arm with 68Ga-DOTATATE
all participants will undergo a PET scan with 68Ga-DOTATATE
Biological: Radiopharmaceutical 68Ga-DOTATATE
Injection of 68Ga-DOTATATE followed by PET/CT acquisition
- Accrual rate [ Time Frame: For the duration of the study, lasting 6 years ]Number of participants enrolled / year
- Rate of adverse events [ Time Frame: Up to 24 hours following injection of 68Ga-DOTATATE ]Number of adverse events (being serious or not) associated to the intervention (injection of 68Ga-DOTATATE and PET/CT acquisition
- Positive lesions for 68Ga-DOTATATE [ Time Frame: One hour post-injection of 68Ga-DOTATATE ]SUV mean of the lesion
- Discordance of positive lesions for 68Ga-DOTATATE and positive lesions of 123I-MIBG [ Time Frame: Within one week (period between 123I-MIBG scan and 68Ga-DOTATATE scan) ]the number of discordant lesions divided by the number of total positive lesions is the discordance rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04559217
|Contact: Daphnee Lamarche, PhD||819-346-1110 ext email@example.com|
|Contact: Amelie Tetu, MSc||819-346-1110 ext firstname.lastname@example.org|
|CIUSSS de L'Estrie-CHUS Hospital|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Contact: Daphnee Lamarche, PhD 819-346-1110 ext 15571 email@example.com|
|Contact: Amelie Tetu, MSc 819-346-1110 ext 15571 firstname.lastname@example.org|
|Principal Investigator: Etienne Rousseau, MD, FRCPC|
|Principal Investigator:||Etienne Rousseau, MD, FRCPC||CIUSSSE-CHUS|