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 januari 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
29
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Aarhus, Denemarken, DK-8000
- Aarhus University Hospital
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Copenhagen, Denemarken, DK-2100
- Rigshospitalet, University of Copenhagen
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Innsbruck, Oostenrijk, A-6020
- Medical University of Innsbruck
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Vienna, Oostenrijk, A-1090
- University Clinic for Radiology and Nuclear Medicine
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California
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Los Angeles, California, Verenigde Staten, 90095
- UCLA Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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
Andere namen:
Positron emission tomography (PET) imaging agent
Andere namen:
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Experimenteel: 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
Andere namen:
Positron emission tomography (PET) imaging agent
Andere namen:
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Experimenteel: 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
Andere namen:
Positron emission tomography (PET) imaging agent
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
26 september 2017
Primaire voltooiing (Werkelijk)
25 juli 2019
Studie voltooiing (Werkelijk)
5 augustus 2019
Studieregistratiedata
Eerst ingediend
26 juni 2017
Eerst ingediend dat voldeed aan de QC-criteria
13 juli 2017
Eerst geplaatst (Werkelijk)
18 juli 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
14 januari 2021
Laatste update ingediend die voldeed aan QC-criteria
8 januari 2021
Laatst geverifieerd
1 januari 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- D-FR-01070-002
- 2016-004928-39 (EudraCT-nummer)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .