To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)
2021. január 8. frissítette: 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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
29
Fázis
- 2. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Innsbruck, Ausztria, A-6020
- Medical University of Innsbruck
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Vienna, Ausztria, A-1090
- University Clinic for Radiology and Nuclear Medicine
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Aarhus, Dánia, Dk-8000
- Aarhus University Hospital
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Copenhagen, Dánia, DK-2100
- Rigshospitalet, University of Copenhagen
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California
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Los Angeles, California, Egyesült Államok, 90095
- UCLA Medical Center
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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)
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Diagnosztikai
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Tényező hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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
Más nevek:
Positron emission tomography (PET) imaging agent
Más nevek:
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Kísérleti: 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
Más nevek:
Positron emission tomography (PET) imaging agent
Más nevek:
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Kísérleti: 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
Más nevek:
Positron emission tomography (PET) imaging agent
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
Időkeret: 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
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2017. szeptember 26.
Elsődleges befejezés (Tényleges)
2019. július 25.
A tanulmány befejezése (Tényleges)
2019. augusztus 5.
Tanulmányi regisztráció dátumai
Először benyújtva
2017. június 26.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2017. július 13.
Első közzététel (Tényleges)
2017. július 18.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2021. január 14.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2021. január 8.
Utolsó ellenőrzés
2021. január 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- D-FR-01070-002
- 2016-004928-39 (EudraCT szám)
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Klinikai vizsgálatok a Satoreotide trizoxetan 5-20μg
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Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Shanghai Public Health Clinical Center; Air Force Military Medical University, China és más munkatársakBefejezve