Preoperative assessment of tumours of the upper urinary tract by photon-counting computed tomography and magnetic resonance tomography
| ISRCTN | ISRCTN87678318 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87678318 |
| Sponsor | Region Skåne |
| Funders | Avtal om Läkarutbildning och Forskning, Gösta Jönsson research foundation, Hillevi Fries research foundation |
- Submission date
- 20/03/2026
- Registration date
- 08/06/2026
- Last edited
- 08/06/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Johannes Bobjer
Principal investigator, Scientific, Public
Principal investigator, Scientific, Public
Department of Urology
Jan Waldenströms gata 5
Skane University hospital
Malmo
20502
Sweden
| 0000-0001-8495-3498 | |
| Phone | +46 (0) 40 331000 |
| johannes.bobjer@med.lu.se |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | Photon-counting computed tomography and magnetic resonance tomography for preoperative risk stratification in upper tract urothelial carcinoma (UTUC) – a prospective trial |
| Study acronym | PiCTURE |
| Study objectives | To evaluate if MRT or PCCT performed preoperatively can identify UTUC stage T2 or higher. |
| Ethics approval(s) |
Approved 28/03/2025, Etikprövningsmyndigheten (Box 2110, Uppsala, 75002, Sweden; +46 (0) 10 4750800; registrator@etikprovning.se), ref: 2025-01538-02 |
| Health condition(s) or problem(s) studied | Upper tract utothelial carcinoma (ureter or renal pelvis) |
| Intervention | The study is a prospective observational study at Skåne University Hospital in Malmö and the Urology Department in Helsingborg. Participating patients will undergo both MRI and PCCT during admission to the urology department, ensuring the time between examination and surgery start is less than a week. The images from MRI/PCCT and their interpretation are blinded to the surgeons and thus do not affect the surgical treatment. After surgery, the pathological tumor stage is recorded and compared with the radiologist’s staging based on 1) MRI including diffusion-weighted images, 2) PCCT, and 3) the combined MDT assessment utilizing only CT urography for staging. A special arm exists for patients receiving preoperative systemic chemotherapy as neoadjuvant or induction therapy. These patients undergo a first MRI/PCCT before starting chemotherapy and a second MRI/PCCT within a week before surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 31/12/2029 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | Morphological (visible on conventional computed tomography images) suspected tumour in the upper urinary tract subjected to radical nephroureterectomy or segmental ureterectomy |
| Key exclusion criteria | 1. Age below 18 years 2. Not possible to give informed consent 3. Contraindication for MRT and PCCT |
| Date of first enrolment | 01/06/2026 |
| Date of final enrolment | 31/12/2029 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
30/03/2026: Study’s existence confirmed by the Swedish Ethics Review Authority, Sweden.