Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
200
Countries
1
Sites
1
Neuroendocrine neoplasms
To develop models based on tumor measurements derived from combined 18FDG and 64Cu-DOTATATE PET/CT scans to predict progression-free survival for patients with neuroendocrine neoplasms.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Jan 2023 → ongoing
- Decision date (initial)
- 2024-08-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516156-18-00
- EudraCT number
- 2021-005919-30
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis
To develop models based on tumor measurements derived from combined 18FDG and 64Cu-DOTATATE PET/CT scans to predict progression-free survival for patients with neuroendocrine neoplasms.
Secondary objectives 3
- To develop models based on tumor measurements derived from combined 18FDG and 64Cu-DOTATATE PET/CT scans to predict overall survival for patients with neuroendocrine neoplasms
- To investigate the proportion of patients with neuroendocrine neoplasms who are considered eligible for peptide receptor radionuclide therapy based on their 64Cu-DOTATATE PET/CT scans
- To evaluate the correlation between tumor radiotracer accumulation on 64Cu-DOTATATE PET/CT with corresponding values on 18FDG PET/CT from combined PET/CT scans from patients with neuroendocrine neoplasms
Conditions and MedDRA coding
Neuroendocrine neoplasms
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10071542 | Neuroendocrine carcinoma metastatic | 100000004864 |
| 24.1 | LLT | 10085958 | Small intestine neuroendocrine tumor | 100000004848 |
| 24.1 | LLT | 10085846 | Duodenal neuroendocrine tumor | 100000004848 |
| 20.0 | LLT | 10077560 | Gastroenteropancreatic neuroendocrine tumor disease | 10029104 |
| 20.0 | PT | 10057270 | Neuroendocrine carcinoma | 100000004864 |
| 27.0 | LLT | 10068916 | Pancreatic neuroendocrine tumor metastatic | 10029104 |
| 21.0 | LLT | 10067518 | Pancreatic neuroendocrine tumor | 10029104 |
| 21.0 | LLT | 10062476 | Neuroendocrine tumor | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age above or of 18 years
- Histopathologically verified gastro-pancreatic neuroendocrine neoplasm (GEP-NEN: GEP NET G1-G3 or GEP-NEC) or unknown primary tumor with NEN-positive metastases suggesting GEP origin on pathology examination.
- Must be able to read and understand the patient information in Danish and to give informed consent.
- WHO Performance status 0-2.
Exclusion criteria 11
- Pregnancy
- Breast-feeding
- Weights more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)
- Uncontrolled diabetes
- Uncontrolled infection
- Exacerbation in autoimmune diseases
- Other active cancer disease
- Conditions or diseases (e.g. uncontrolled Parkinson’s disease) making the patient unable to lie still in the scanner
- Severe claustrophobia
- Localized neuroendocrine neoplasms of the appendix, the rectum measuring < 1 cm, and ECL-omas of the stomach
- History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18FDG or 64Cu-DOTATATE
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression free survival (PFS).
Secondary endpoints 3
- Overall survival (OS)
- The proportion of patients who are considered eligible for peptide receptor radionuclide therapy based on their 64Cu-DOTATATE PET/CT scan
- The correlation between standardized uptake values from tumors and healthy tissues derived from manually depicted regions-of-interests measured on 18FDG and 64Cu-DOTATATE
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Fluor-18-FDG, 400 MBq-210 GBq, injektionsvreske Fludeoxyglucose (18F)
PRD3209304 · Product
- Active substance
- Fludeoxyglucose (18F)
- Substance synonyms
- FLUDEOXYGLUCOSE F 18, FLUORODEOXYGLUCOSE F18, ALPHA-D-GLUCOPYRANOSE, 2-DEOXY-2-(FLUORO-18F), 18F-FLUDEOXYGLUCOSE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 MBq megabecquerel(s)
- Max total dose
- 500 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX04 — -
- Marketing authorisation
- DK R 14
- MA holder
- CYKLOTRON & RADIOCHEMISTRY, UNIT 3982, RIGSHOSPITALET
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10203490 · Product
- Active substance
- Dotatate
- Substance synonyms
- DOTA-TATE, DOTA-OCTREOTATE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- 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
- RHPET
- 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
- Mathias Loft
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Mathias Loft
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 200 | 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 | 2023-01-17 | 2023-01-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516156-18 | 5 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF group 1 | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF group 2 | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF group 3 | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Fluor-18-FDG | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DK 2024-516156-18 | 4 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-07 | Denmark | Acceptable 2024-08-16
|
2024-08-20 |