Primary objective is to investigate the feasibility of Hexvix® blue light URS. Secondary objectives are to determine the diagnostic value of Hexvix® blue light URS as compared to digital and fiberoptic white light URS, and to assess safety and…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-The number of patients with histology-confirmed tumors found by blue light URS
Secondary outcome
All lesions must be histologically confirmed:
-The proportion of patients with tumor(s) found by blue light URS, but not on
white light (fiberoptic or digital) URS
-The proportion of patients with tumor(s) found by white light (fiberoptic or
digital) URS, but not on blue light URS
-The proportion of false-positive lesions on blue light URS and white light
(fiberoptic or digital) URS
-The detection rate of white light (fiberoptic or digital) URS combined with
blue light URS for patients with tumor(s).
-Registration of adverse events
Background summary
The detection of urothelial cell carcinoma (UCC) in the upper urinary tract is
suboptimal, as malignant lesions are easily missed by the currently considered
golden standard: digital white light uretero-renoscopy (URS) (previously, the
golden standard was white light fiberoptic URS). Blue light (fluorescence)
cystoscopy in combination with administration of photoactive porphyrins
(Hexvix®) has improved the detection of non-muscle invasive bladder UCC. In
this study we use the same technique for the upper urinary tract (UUT), by
using a blue light URS, in order to improve the detection rate of UCC in the
UUT.
Study objective
Primary objective is to investigate the feasibility of Hexvix® blue light URS.
Secondary objectives are to determine the diagnostic value of Hexvix® blue
light URS as compared to digital and fiberoptic white light URS, and to assess
safety and toxicity of Hexvix® administered to the upper urinary tract.
Study design
prospective, comparative, single center study (Radboud University Nijmegen
Medical Centre), exploring the feasibility of blue light URS, and comparing
blue light fiberoptic URS with digital and fiberoptic white light URS in the
detection of urothelial cell carcinoma (UCC) of the upper urinary tract (UUT),
in 15 patients with known UCC or suspicion for UCC of the proximal ureter
and/or pyelum. Expected time needed for inclusion: 1 year.
Patients undergo both digital white light uretero-renoscopy (URS) (part of
routine medical treatment) as well as blue light fiberoptic URS preceded by
titration of 42.5 mg Hexvix®/20 ml solvent for 30 minutes in both ureters/pyela
(this is extra for study purposes). Any lesion suspect for UCC will be
biopsied.
Study burden and risks
Risks: -prolonged operation time of approximately 45 minutes
-side-effects of Hexvix®
Benefits: -possibly better detection of UCC
-possibly more radical resection of UCC
Hexvix® is registered for intravesical administration, and has less
side-effects than other for the bladder registered drugs: mitomycin-C
(chemotherapy) or BCG (immunotherapy). Mitomycin-C and BCG can safely be
applied to the upper urinary tract. We expect the same for Hexvix®.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
-Patients with known urothelial cell carcinoma (UCC) of the upper urinary tract (UUT)
-Patients with suspicion for UCC of the UUT based on one of the following:
-unilateral or bilateral ureter sampling (suspect or malignant cells on cytology)
-suspect or malignant cells on urine cytology, with negative bladder biopsies
-macroscopic tumor on previous uretero-renoscopy
-tumor seen on imaging techniques (ultrasound, IVP, CT, MRI)
-Patients with ZUBROD-ECOG-WHO performance status of 0-2
-Patients must be over 18 years of age
-Patients must be fully informed of the investigational nature of the study and signed written informed consent must be obtained prior to any study specific investigations
Exclusion criteria
-Patients with existing or recurrent severe urinary tract infection
-Gross haematuria (defined as heavy bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence uretero-renoscopy. Where the bleed is light, the patient should not be excluded if in the investigator*s opinion rinsing during uretero-renoscopy will alleviate the possible interference with fluorescence cystoscopy)
-Patients with porphyria
-Known allergy to hexyl aminolevulinate hydrochloride or a similar compound
-Pregnant or breast-feeding (patients must use adequate birth control methods while on the study and for 4 weeks following the end of treatment)
-Patients who have received BCG or chemotherapy in the UUT within 3 months prior to uretero-renoscopy
-Conditions associated with a risk of poor protocol compliance
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-005403-17-NL |
| CCMO | NL19885.091.07 |