Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
20
Countries
1
Sites
1
large cell neuroendocrine lung cancer
The aim of this study is to investigate the uptake of the new positron emission tomography (PET-)tracer 68Ga-satoreotide trizoxetan in patients with high-grade neuroendocrine lung cancer.
Key facts
- Sponsor
- Rigshospitalet, Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Aug 2023 → 23 Jun 2025
- Decision date (initial)
- 2023-05-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Ariceum-Therapeutics GmbH
External identifiers
- EU CT number
- 2023-503362-24-01
- WHO UTN
- U1111-1287-8640
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
The aim of this study is to investigate the uptake of the new positron emission tomography (PET-)tracer 68Ga-satoreotide trizoxetan in patients with high-grade neuroendocrine lung cancer.
Secondary objectives 4
- To evaluate the number and location of 68Ga-satoreotide trizoxetan-avid lesions in each patient compared with the number and location of lesions that has been detected previously by standard imaging procedures (CT or, when available, [18F]FDG-PET/CT).
- To quantify the 68Ga-satoreotide trizoxetan-uptake (standardized uptake value (SUV): SUVmax, SUVpeak, SUVmean, and functional tumor volume delineated by 68Ga-satoreotide trizoxetan) in SCLC and LCNEC
- To quantify 68Ga-satoreotide trizoxetan-uptake (SUVmax, SUVpeak) in background organs (e.g., lung, kidney, spleen, liver, lymph nodes, brain) in patients with SCLC and LCNEC
- To assess the tumor-to-background ratio of 68Ga-satoreotide trizoxetan
Conditions and MedDRA coding
large cell neuroendocrine lung cancer
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-503362-24-00 | 68Ga satoreotide trizoxetan PET/CT in patients with high grade neuroendocrine lung cancer | Rigshospitalet |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Pathologically verified SCLC or LCNEC
- Age ≥ 18 years
- Informed oral and written consent
Exclusion criteria 9
- Unknown primary tumor
- Previous radiotherapy to target lesions in the lungs
- Previous or current treatment with somatostatin analogues
- Current complete response to therapy
- Carcinoid syndrome
- Other active malignancy, except for non-melanoma skin cancer
- Pregnancy or lactation
- Allergy to somatostatin analogues
- Communication difficulties, including inability to understand the oral and/or written study material
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The fraction of patients with SCLC and LCNEC who have at least one malignant lesion that can be identified with 68Ga-satoreotide trizoxetan-PET
Secondary endpoints 4
- Number and location of lesions that have been identified by 68Ga-satoreotide trizoxetan-PET in each patient will be compared with the number and location of known malignant lesions (identified by previous CT-scans, and if available, [18F]FDG-PET/CT) to evaluate the lesion-based diagnostic efficacy and to describe sites of disagreement.
- SUVmax, SUVpeak, SUVmean, and functional tumor volume delineated by 68Ga-satoreotide trizoxetan-PET will be measured in the identified malignant lesions
- SUVmax and SUVpeak will be measured in background organs (e.g., lung, kidney, spleen, liver, lymph nodes, and brain).
- The quantitative parameters in the malignant lesions will be divided by the corresponding 68Ga-satoreotide trizoxetan-uptake in background organs to estimate tumor-to-background ratio.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Satoreotide Trizoxetan Gallium GA-68
PRD9967189 · Product
- Active substance
- Satoreotide Trizoxetan Gallium GA-68
- Substance synonyms
- OPS-202 GA-68, 68Ga-2,2'-(7-(4-((S)-1-((4S,7S,10S,13R,16S,19R)-4-((R)-1-amino-3-(4-hydroxyphenyl)-1-oxopropan-2-ylcarbamoyl)-10-(4-aminobutyl)-16-(4-((S)-2,6-dioxohexahydropyrimidine-4-carboxamido)benzyl)-7-((R)-1-hydroxyethyl)-6,9,12,15,18-pentaoxo-13-(4-ureidobenzyl)-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-19-ylamino)-3-(4-chlorophenyl)-1-oxopropan-2-ylamino)-1-carboxy-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetic acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 200 MBq megabecquerel(s)
- Max total dose
- 200 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BARBARA MALENE FISCHER
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Dept of clinical physiology and nuclear medicin
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Dept of clinical physiology and nuclear medicin
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring, Other |
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Dept of clinical physiology and nuclear medicin
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Dept of clinical physiology and nuclear medicin
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring, Other |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Rigshospitalet
Department of Clinical Physiology and Nuclear Medicine, Blegdamsvej 9, 2100, Copenhagen Oe
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-08-09 | 2025-06-23 | 2023-08-10 | 2024-04-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-24 | Denmark | Acceptable 2023-05-01
|
2023-05-10 |