To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
8 janvier 2021 mis à jour par: Ipsen
A Multicentre, Randomised, Dose-confirmation, Factorial Phase II Study to Evaluate the Optimal Dose of 68Ga-OPS202 as a PET Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
The purpose of this clinical research is to confirm the optimal dose of 68Ga-satoreotide trizoxetan (68Ga-IPN01070), formerly 68Ga-OPS202, as a PET imaging agent to be used to detect and localize gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs).
68Ga-IPN01070 is a radiolabelled imaging agent to be used in association with Positron-Emission-Tomography (PET).
68Ga-IPN01070 is made of two main components: 1) IPN01070, an antagonistic somatostatin analogue which binds to the somatostatin receptor (type 2) present on the surface of the tumor cells and 2) Gallium-68, a radioisotope that combined with IPN01070 can be seen in the PET scanner.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
29
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Aarhus, Danemark, Dk-8000
- Aarhus University Hospital
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Copenhagen, Danemark, DK-2100
- Rigshospitalet, University of Copenhagen
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Innsbruck, L'Autriche, A-6020
- Medical University of Innsbruck
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Vienna, L'Autriche, A-1090
- University Clinic for Radiology and Nuclear Medicine
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California
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Los Angeles, California, États-Unis, 90095
- UCLA Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Pathologically confirmed, well differentiated functioning or non-functioning metastatic GEP-NET (Grade I and II as per World Health Organisation classification 2010)
- Confirmed presence of somatostatin receptors (type 2) on technically evaluable tumour lesions documented by a positive Somatostatin Receptor Scan acquired within 6 months prior to screening (Visit 1) and showing minimally two lesions in at least one of the key organs; these images shall be available to be sent to the imaging core lab electronically to ascertain quality and admissibility
- Body weight between 50 kg (110 lb) and 110 kg (243 lb), inclusive
- Adequate bone marrow, liver and renal function
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Exclusion Criteria:
- Fewer than five lesions in total and more than 25 lesions/organ detected by the previous somatostatin receptor scan in key organs: liver, lymph nodes, bone or lungs
- Subject who have received treatment of any somatostatin analogue, including Somatuline® Autogel® /Depot®, Sandostatin® LAR within 28 days, and Sandostatin® within 24 hours prior to first 68Ga-OPS202 administration
- Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
- Any condition that precludes the proper performance of PET and/or CT scan: a) Subjects who are not able to tolerate the CT contrast agent, b) Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis, c) Subjects unable to raise arms for prolonged imaging purposes, d) Subjects unable to lie still for the entire imaging time, e) Subjects weighing greater than 110 kg (243 lb)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 5-20μg/40-80 MBq, 30-45μg/100-140 MBq
Subjects will receive a first intravenous (i.v.) injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 40 to 80 MBq.
After 15 to 21 days the subjects will receive a second i.v.
injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 100 to 140 MBq.
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Positron emission tomography (PET) imaging agent
Autres noms:
Positron emission tomography (PET) imaging agent
Autres noms:
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Expérimental: 5-20μg/100-140 MBq, 30-45μg/160-200 MBq
Subjects will receive a first i.v.
injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 100 to 140 MBq.
After 15 to 21 days the subjects will receive a second i.v.
injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 160 to 200 MBq.
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Positron emission tomography (PET) imaging agent
Autres noms:
Positron emission tomography (PET) imaging agent
Autres noms:
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Expérimental: 5-20μg/160-200 MBq, 30-45μg/40-80 MBq
Subjects will receive a first i.v.
injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 160 to 200 MBq.
After 15 to 21 days the subjects will receive a second i.v.
injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 40 to 80 MBq.
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Positron emission tomography (PET) imaging agent
Autres noms:
Positron emission tomography (PET) imaging agent
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
Délai: Day 1 and Days 16 to 22
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For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by standard-of-truth (SoT).
The SoT in this study was the contrast enhanced (ce)CT scan images acquired at Visit 2 (Day 1) and Visit 3 (Days 16 to 22).
Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range after the 1st and 2nd injections.
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Day 1 and Days 16 to 22
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Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges
Délai: Day 1 and Days 16 to 22
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For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by SoT.
The SoT in this study was the ceCT scan images acquired at Visit 2 (Day 1) and Visit 3 (Day 16 to 22).
Relative lesion counts for PET/CT and PET readings are presented for all organs, primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
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Day 1 and Days 16 to 22
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
Délai: Day 1 and Days 16 to 22
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For each PET assessment, image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs.
The tumour-to-background ratio was computed by mean standardised uptake value (SUVmean) of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood).
A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent.
Tumour-to-background ratios are presented for primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range.
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Day 1 and Days 16 to 22
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Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges
Délai: Day 1 and Days 16 to 22
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For each PET assessment image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs.
The tumour-to-background ratio was computed by SUVmean of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood).
A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent.
Tumour-to-background ratios are presented for primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
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Day 1 and Days 16 to 22
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Image Quality as Assessed by Independent Blinded Readers Quality Score
Délai: Day 1 and Days 16 to 22
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A qualitative analysis of the image was assessed by 2 independent blinded readers using a quality score (performed as a back-up to the quantitative quality measured by tumour-to-background analysis).
For each PET/CT and PET assessment, each reader performed a direct comparison of the 2 scans from Visit 2 and Visit 3.
They noted which scan provided superior images based on overall image quality and lesion count and attributed a score for each assessment.
The score for the assessment having superior images was set to "1", and score for the assessment not selected was set to "0".
In case of equal quality, both assessments had a score of "1".
The image quality score for PET/CT and PET readings as cumulative sum of readers' scores across all subjects by peptide mass and radioactivity dose range combination is presented.
Score ranges from 0-16 with higher score indicating more assessments classed as superior.
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Day 1 and Days 16 to 22
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Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
Délai: Day 1 and Days 16 to 22
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For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that were confirmed by SoT assessment.
In order to obtain a unique measure per organ, values of the SUVmax were computed within each of the following organs; liver, lymph nodes, bone and lungs.
SUVmax results are presented for primary site of GEP-NET and per organ by each combination of injected peptide/radioactivity dose range.
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Day 1 and Days 16 to 22
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Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges
Délai: Day 1 and Days 16 to 22
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For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that are confirmed by SoT assessment.
In order to obtain a unique measure per organ, mean of the SUVmax was computed within each of the liver, lymph nodes, bone and lungs.
SUVmax results are presented for primary site of GEP-NET and per organ by both peptide mass range and radioactivity dose range.
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Day 1 and Days 16 to 22
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Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
Délai: Day 1 and Days 16 to 22
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For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, liver, lymph nodes, axial/appendicular skeleton (bone) and lungs.
The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose range.
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Day 1 and Days 16 to 22
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Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
Délai: Day 1 and Days 16 to 22
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For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs.
The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by both peptide mass range and radioactivity dose range.
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Day 1 and Days 16 to 22
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Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
Délai: Day 1 and Days 16 to 22
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For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs.
The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan.
A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan.
A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan.
The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose range.
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Day 1 and Days 16 to 22
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Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
Délai: Day 1 and Days 16 to 22
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For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs.
The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan.
A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan.
A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan.
The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites results are presented by both peptide mass range and radioactivity dose range.
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Day 1 and Days 16 to 22
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Collaborateurs et enquêteurs
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Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
26 septembre 2017
Achèvement primaire (Réel)
25 juillet 2019
Achèvement de l'étude (Réel)
5 août 2019
Dates d'inscription aux études
Première soumission
26 juin 2017
Première soumission répondant aux critères de contrôle qualité
13 juillet 2017
Première publication (Réel)
18 juillet 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 janvier 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 janvier 2021
Dernière vérification
1 janvier 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D-FR-01070-002
- 2016-004928-39 (Numéro EudraCT)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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