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®)
Key facts
- Where
- Marseille, FranciaországSee the site
- Phase
- 2. fázis
Where in Franciaország
- Institut Paoli-CalmettesMarseille, FranciaországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institut Paoli Calmettes
- Trial code
- EU 2026-526917-27-00
- Record updated
- 2026. szeptember 30.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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; 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.