Overview
Sponsor-declared trial summary
Breast cancer, neuroendocrine neoplasms, lymphomas, sarcomas
Proof-of-concept for the feasibility of simultaneous hyperpolarized [1-13C]Pyruvate Magnetic Resonance Spectroscopy Imaging and radiolabeled 18-Flouro-deoxy-glucose Positron Emission Tomography imaging in a PET/MR scanner in cancer patients
Key facts
- Sponsor
- 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] - Investigative Techniques [E05]
- Trial duration
- 18 Apr 2022 → ongoing
- Decision date (initial)
- 2024-08-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516131-28-00
- EudraCT number
- 2021-004996-14
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy
Proof-of-concept for the feasibility of simultaneous hyperpolarized [1-13C]Pyruvate Magnetic Resonance Spectroscopy Imaging and radiolabeled 18-Flouro-deoxy-glucose Positron Emission Tomography imaging in a PET/MR scanner in cancer patients
Secondary objectives 2
- Quantification and comparison of the tumor and healthy tissue uptake of 18-Flouro-deoxy-glucose and [1-13C]Pyruvate to [1-13C]Lactate conversion.
- If possible, tissue samples/biopsies from tumor tissue will be collected from the included patients, allowing us to analyze the expression of biomarkers associated with intracellular metabolism using conventional molecular biology methods (immunohistochemicy / ELISA / qPCR and microRNA) and to correlate the findings with the results obtained from the PET/MR scans.
Conditions and MedDRA coding
Breast cancer, neuroendocrine neoplasms, lymphomas, sarcomas
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10068916 | Pancreatic neuroendocrine tumor metastatic | 10029104 |
| 20.0 | LLT | 10077560 | Gastroenteropancreatic neuroendocrine tumor disease | 10029104 |
| 20.0 | PT | 10057270 | Neuroendocrine carcinoma | 100000004864 |
| 27.0 | PT | 10071542 | Neuroendocrine carcinoma metastatic | 100000004864 |
| 15.1 | HLGT | 10041299 | Soft tissue sarcomas | 10029104 |
| 20.0 | HLT | 10039498 | Bone sarcomas | 10029104 |
| 20.0 | LLT | 10006192 | Breast cancer NOS | 10029104 |
| 21.0 | LLT | 10067518 | Pancreatic neuroendocrine tumor | 10029104 |
| 20.0 | HLT | 10039499 | Cartilage sarcomas | 10029104 |
| 21.0 | LLT | 10062476 | Neuroendocrine tumor | 10029104 |
| 20.0 | HLGT | 10025323 | Lymphomas NEC | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Diagnosed with one of the following cancers: breast cancer, neuroendocrine neoplasm, lymphoma or sarcoma with a tumor size of at least 1.5 cm.
Exclusion criteria 6
- Pregnancy
- Breast-feeding
- Weighs more 140 kg and/or with abdominal circumference exceeding the gantry of the PET/MR coils
- History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FDG or pyruvate
- Unable to lie in the PET/MR scanner for up to 90 minutes
- MR contraindications: Pace-maker, metal implantations within the past 6 weeks, non-MR compatible implants, claustrophobia
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Quantification of tumor [1-13C]Pyruvate to [1-13C]Lactate conversion measured through dynamic conversion factors and signal ratios.
- Quantification of tumor uptake of 18-Flouro-deoxy-glucose measured as dynamic glucose influx (Ki) and static standardized uptake values (SUV).
Secondary endpoints 1
- Correlation between tumor 18-Flouro-deoxy-glucose uptakes and [1- 13C]Pyruvate to [1-13C]Lactate conversion and ex-vivo non-quantitative and quantitative expression of biomarkers involved in intracellular metabolism.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Hyperpolarized [1-13C]pyruvate
PRD10284730 · Product
- Active substance
- Pyruvic Acid
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.24 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.24 mmol/kg millimole(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AARHUS UNIVERSITY
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
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
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 | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2022-04-18 | 2022-04-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516131-28 | 6 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Fluor-18-FDG | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DK 2024-516131-28 | 4 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-08 | Denmark | Acceptable 2024-08-27
|
2024-08-28 |