2026-526917-27-00Not yet recruitingPhase 2
Hex-SUB1-IPC 2025-067 - PROOF OF CONCEPT: FEASIBILITY OF PHOTODYNAMIC DIAGNOSIS IN BLADDER CANCER PATIENTS WITH SUB-ONE-HOUR INSTILLATION TIME OF HEXAMINOLEVULINATE (HEXVIX®)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Sept 2026
Brief summary (registry, in English)
The main objective is to evaluate the quality of tumor fluorescence by Hexvix® when the blue light cystoscopy is started 30 min after the timepoint of instillation of Hexvix® into the bladder.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 19 Jun 2026
- Start date
- 6 Nov 2026
- Lead sponsor
- Institut Paoli Calmettes
- Diseases
- Bladder cancer
- EU CT number
- 2026-526917-27-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a bladder tumour of the papillary type, first-time or returned, who are scheduled for tumour removal through the urethra (TURB) with Hexvix®. It tests blue light cystoscopy started 30 minutes after Hexvix® is put into the bladder.
- Age
- Over 18 years
- Sex
- Men and women
- Disease stage
- First-time or recurrent papillary bladder cancer, confirmed by cystoscopy or imaging, scheduled for TURB with Hexvix®.
- Earlier treatment
- No previous pelvic radiotherapy. No recent treatment placed in the bladder (BCG or chemotherapy).
Main reasons for not taking part
- Flat lesion without a papillary tumour
- Tumour that has grown into the bladder muscle, with maximal TURB before radio-chemoradiotherapy
- Previous diagnosis of porphyria, or hypersensitivity to hexaminolevulinate hydrochloride or its excipients
- Pregnant or breastfeeding women, or women who may become pregnant without effective contraception
- Urethral stricture, or a bladder that cannot hold the Hexvix® solution
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cystoscopy or bladder biopsies performed without previously identified tumor lesions
- Previous diagnosis of porphyria
- Maximal TURB for muscle-invasive bladder tumor (prior to radio-chemoradiotherapy)
- Other TURB procedures not requiring prior Hexvix® instillation
- Previous pelvic radiotherapy
Other illness
- Bladder inflammation related to chronic urinary tract infection or mechanical irritation of the bladder mucosa due to indwelling catheter or recent intravesical treatment (BCG or chemotherapy)
- Any severe uncontrolled medical condition considered by the investigator as a contraindication for using tested product
- Hypersensitivity to the active substance hexaminolevulinate hydrochloride or to any of the excipients listed in section 6.1. of the SmPC
Other
- Vessie peu compliante / capacité vésicale insuffisante ne permettant pas de retenir le Hexvix
- Adults under legal protection (guardianship, curatorship, or judicial protection);
- Inability to comply with the medical follow-up of the trial for geographical, social, or psychological reasons.
- Flat lesion without papillary tumor associated
- Urethral stricture
- Pregnant women or those who may become pregnant (without effective contraception) or breastfeeding
Who the study is looking for
- man/woman above 18 years
- primary or recurrent papillary bladder cancer confirmed by cystoscopy or imaging, scheduled for TURB with Hexvix®
- Covered by a Healthcare System;
- Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Paoli-Calmettes | Marseille | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.