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

Department of Urology
Jan Waldenströms gata 5
Skane University hospital
Malmo
20502
Sweden

ORCiD logoORCID ID 0000-0001-8495-3498
Phone +46 (0) 40 331000
Email johannes.bobjer@med.lu.se

Study information

Primary study designObservational
Observational study designCohort study
Scientific titlePhoton-counting computed tomography and magnetic resonance tomography for preoperative risk stratification in upper tract urothelial carcinoma (UTUC) – a prospective trial
Study acronymPiCTURE
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) studiedUpper tract utothelial carcinoma (ureter or renal pelvis)
InterventionThe 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 typeProcedure/Surgery
Primary outcome measure(s)
  1. Precision of radiologists image review of MRT and PCCT for local T-stage measured using sensitivity, specificity, positive and negative predictive value in comparison to the pathologic report at evaluation after surgery
Key secondary outcome measure(s)
Completion date31/12/2029

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit100 Years
SexAll
Target sample size at registration100
Key inclusion criteriaMorphological (visible on conventional computed tomography images) suspected tumour in the upper urinary tract subjected to radical nephroureterectomy or segmental ureterectomy
Key exclusion criteria1. Age below 18 years
2. Not possible to give informed consent
3. Contraindication for MRT and PCCT
Date of first enrolment01/06/2026
Date of final enrolment31/12/2029

Locations

Countries of recruitment

  • Sweden

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo

Editorial Notes

30/03/2026: Study’s existence confirmed by the Swedish Ethics Review Authority, Sweden.