Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
420
Countries
3
Sites
11
Metastatic breast cancer
The primary objective of the MONITOR-RCT is to demonstrate that in patients with MBC, response monitoring based on FDG-PET/CT is superior to response monitoring based on CT with respect to overall survival. The objective will be based on applying standardized response evaluation criteria, using an appropriate adaptatio…
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 25 Feb 2025 → ongoing
- Decision date (initial)
- 2024-10-14
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
The primary objective of the MONITOR-RCT is to demonstrate that in patients with MBC, response monitoring based on FDG-PET/CT is superior to response monitoring based on CT with respect to overall survival. The objective will be based on applying standardized response evaluation criteria, using an appropriate adaptation of the PERCIST criteria for FDG-PET/CT and the RECIST1.1 criteria for CT.
Secondary objectives 1
- Secondary objectives of the MONITOR-RCT are to demonstrate superiority with respect to the quality of life and time and exposure to treatment and to investigate the cost-effectiveness
Conditions and MedDRA coding
Metastatic breast cancer
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-506550-20-00 | FDG-PET/CT versus conventional CT for response monitoring in metastatic breast cancer: A pilot study for a randomized clinical trial (MONITOR-PILOT) | Odense University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Women and men aged≥18 years
- Diagnosis of distant relapsed MBC (biopsy-verified) or de novo breast cancer. In patients with distant relapsed MBC, biopsy verification from a distant metastasis is required. In patients with de novo MBC, biopsy verification of primary tumor and diagnostic imaging with distant metastasis with a typical pattern of MBC is required.
- Considered eligible for first-line systemic treatment
- Considered eligible for continuous treatment monitoring by scans
- Signed informed consent
- Participants must have the ability to read and understand the following languages based on their country of participation: in Denmark, patients must be able to read and understand Danish; in Italy, they must be able to read and understand Italian or English; and in Germany, they must be able to read and understand German or English.
Exclusion criteria 4
- Pregnant or lactating women
- Ongoing oncological treatment for another cancer
- Exclusively brain metastasis
- Allergy to FDG
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Overall survival
Secondary endpoints 3
- Quality of life
- Time and exposure to oncologic treatment
- Cost-effectiveness
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP13264019 · ATC
- Active substance
- Fludeoxyglucose (18F)
- Substance synonyms
- FLUDEOXYGLUCOSE F 18, FLUORODEOXYGLUCOSE F18, ALPHA-D-GLUCOPYRANOSE, 2-DEOXY-2-(FLUORO-18F), 18F-FLUDEOXYGLUCOSE
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 400 MBq megabecquerel(s)
- Max total dose
- 400 MBq megabecquerel(s)
- Max treatment duration
- 54 Month(s)
- Authorisation status
- Authorised
- ATC code
- V09IX04 — FLUDEOXYGLUCOSE (18F)
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Malene Grubbe Hildebrandt
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Malene Grubbe Hildebrandt
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| University Of Basel ORG-100030628
|
Basel, Switzerland | Code 10, Code 11 |
| University of Southern Denmark ORG-100031250
|
Odense C, Denmark | Data management |
| Lunds Universitet ORG-100028108
|
Malmo, Sweden | Other, Interactive response technologies (IRT) |
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, E-data capture, Code 8 |
Locations
3 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 240 | 8 |
| Germany | Authorised, recruitment pending | 60 | 1 |
| Italy | Ongoing, recruiting | 120 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Aalborg University Hospital
Department of Nuclear Medicine, Hobrovej 18-22, 9000, Aalborg
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Aarhus Universitet
Department of Nuclear Medicine, Vennelyst Boulevard 6, 8000, Aarhus
Lillebaelt Hospital
Department of Nuclear Medicine, Beriderbakken 4, 7100, Vejle
Copenhagen University Hospital
Department of Oncology, Ringvej 75, 2730, Herlev
Esbjerg Og Grindsted Sygehus
Department of Nuclear Medicine, Finsensgade 35, 6700, Esbjerg
Odense University Hospital
Department of Nuclear Medicine, Kloevervaenget 47, 5000, Odense C
Sygehus Soenderjylland Soenderborg
Department of Oncology, Sydvang 1, 6400, Soenderborg
Technical University Of Munich School Of Medicine
Department of Nuclear Medicine, Ismaninger Strasse 22, Au-Haidhausen, Munich
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 | 2025-02-25 | 2025-04-02 | |||
| Italy | 2026-01-28 | 2026-02-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 37 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-508591-11-00 | 3 |
| Protocol (for publication) | D4_Patient facing document EQ-5D-5L questionnaire_Danish | 1 |
| Protocol (for publication) | D4_Patient facing document EQ-5D-5L questionnaire_English | 1 |
| Protocol (for publication) | D4_Patient facing document EQ-5D-5L questionnaire_German | 1 |
| Protocol (for publication) | D4_Patient facing document EQ-5D-5L questionnaire_Italian | 1 |
| Protocol (for publication) | D4_Patient facing document FACT-B questionnaire_Danish | 1 |
| Protocol (for publication) | D4_Patient facing document FACT-B questionnaire_English | 1 |
| Protocol (for publication) | D4_Patient facing document FACT-B questionnaire_German | 1 |
| Protocol (for publication) | D4_Patient facing document FACT-B questionnaire_Italian | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | Consenso informato italiano v2 | 2 |
| Subject information and informed consent form (for publication) | Informativa per MMG v1 -Milan | 1 |
| Subject information and informed consent form (for publication) | L1_ICF description | 2 |
| Subject information and informed consent form (for publication) | L1_ICF description_DK | 1 |
| Subject information and informed consent form (for publication) | L1_ICF description_ENG | 1 |
| Subject information and informed consent form (for publication) | L1_ICF description_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS description | 2 |
| Subject information and informed consent form (for publication) | L1_SIS description_DK | 2 |
| Subject information and informed consent form (for publication) | L1_SIS description_ENG | 2 |
| Subject information and informed consent form (for publication) | L1_SIS description_English | 3 |
| Subject information and informed consent form (for publication) | L1_SIS description_German | 3 |
| Subject information and informed consent form (for publication) | L1_SIS description_IT | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material description | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material description | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC FLUDEOXYGLUCOSE 18F_Aarhus | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC FLUDEOXYGLUCOSE 18F_Bologna | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC FLUDEOXYGLUCOSE 18F_EMA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC FLUDEOXYGLUCOSE 18F_Herlev | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC FLUDEOXYGLUCOSE 18F_Milan and Bologna | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC FLUDEOXYGLUCOSE 18F_Munich | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC FLUDEOXYGLUCOSE 18F_Odense | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC FLUDEOXYGLUCOSE 18F_Rigs | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-508591-11-00_ENG | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-508591-11-00_IT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-508591-11-00_IT_V2 | 2 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-04 | Denmark | Acceptable 2024-10-11
|
2024-10-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-02 | Acceptable 2024-10-11
|
2025-07-02 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-01 | Acceptable 2024-10-11
|
2025-10-01 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-22 | Acceptable | 2026-02-17 |