Plain English Summary
Background and study aims
Most cancers use more glucose (a type of sugar) than normal cells. FDG is a molecule that is taken up by cancer cells in the same way as glucose and can be visualised in a PET scan to show where there are tumours in the body. This technique is widely used to investigate whether breast cancer has spread to other areas of the body, but it is not clear whether it would also be useful in the early stages of breast cancer, when the cancer can still be treated with surgery alone.
This study will use medical records of patients diagnosed with breast cancer at a Brussels hospital in the years from 2002 to 2015. It will look at the FDG-PET imaging the patients received and how long they survived without cancer and in total to see if there are any patterns.
Who can participate?
There is no active participation in this study. Medical records of people treated 2002-2015 will be analysed.
What does the study involve?
The researchers will take information from medical records and FDG-PET scans. This information will be analysed to see if there are any links between certain FDG-PET results and whether patients were more or less likely to die from their breast cancer.
What are the possible benefits and risks of participating?
There are no potential risks or benefits to participants.
Where is the study run from?
Brussels University Hospital (Belgium)
When is the study starting and how long is it expected to run for?
July 2015 to January 2020
Who is funding the study?
The investigator is funding the costs of the study.
Who is the main contact?
Dr Vincent Vinh-Hung, email@example.com
Prognostic value of pre-treatment 18FDG-PET in operable breast cancer
18FDG-PET is a significant predictor of outcome in breast cancer.
Approved 21/10/2015, Commissie Medische Ethiek (O.G. 016) Universitair Ziekenhuis Brussel [Brussels University Hospital Medical Ethics Committee] (Reflectiegroep Biomedische Ethiek, Laarbeeklaan 101, 1090 Brussels, Belgium; +32 2 477 55 84; firstname.lastname@example.org), ref: B.U.N. 143201525542
Single-centre retrospective observational study with longitudinal cohorts 2002-2008 and 2009-2015
Primary study design
Secondary study design
Patient information sheet
No participant information sheet available
Operable breast cancer.
Records of patients with breast cancer who received pre-operative 18FDG-PET scans will be included. The records will be anonymised and the following types of data extracted:
1. Clinical-pathological characteristics, including age at diagnosis, histological tumor type, pathological grade etc
2. FDG-PET characteristics, including PET positivity and standard uptake value (SUV) etc
3. Outcomes, including local and regional recurrence, disease status at last follow-up, cause of death etc
4. Dates, including date of histological diagnosis, date of recurrence etc
Primary outcome measure
1. Overall survival up to 13 years after diagnosis assessed using patient medical records
2. Disease-free survival up to 13 years after diagnosis assessed using patient medical records
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Patients treated at the UZ Brussel
2. Diagnosed in the period 2002-2015
3. Primary breast cancer
4. Histologically confirmed
6. Pre-treatment FDG-PET or PET/CT
Target number of participants
Participant exclusion criteria
1. Previous history of cancer
2. Primary sarcoma of the breast
3. Palliative surgery for symptom control
4. No histopathological confirmation of cancer
5. Noninvasive carcinoma
6. Metastatic disease demonstrated by imaging modes other than FDG-PET
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Oncologisch Centrum, UZ Brussel
Universitair Ziekenhuis Brussel
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
End analyses and publication expected from June to December 2020.
IPD sharing statement:
The datasets generated at the analysis of the study will be made available upon request from the main contact, Vincent Vinh-Hung (email@example.com or firstname.lastname@example.org), who will inform the UZ Brussel Ethics Committee.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
- ISRCTN17962845_Protocol_v1.03_22Jul2015.pdf Uploaded 12/05/2020