Photodynamic Diagnosis of Kidney Cancer Using Fluorescence Endoscopy and Oral 5-ALA
ConditionKidney Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenry Ford Health System
About this trial
The goal of this prospective, single-arm feasibility study is to evaluate the safety and feasibility of using Gleolan® (5-aminolevulinic acid), an FDA-approved drug currently used during brain tumor surgery, in adults with suspected kidney cancer undergoing partial nephrectomy. Gleolan has shown promise in improving the visualization of cancerous tissue, and this study aims to assess its potential use in urologic oncology. The main questions it aims to answer are:
* Is Gleolan safe and well tolerated in patients with suspected kidney cancer undergoing partial nephrectomy? * Is the use of Gleolan feasible for fluorescence-guided identification of kidney cancer lesions during surgery?
Participants will:
* Receive Gleolan before surgery according to the study protocol. * Undergo partial nephrectomy, during which fluorescence imaging will be used to evaluate the visualization of kidney tumor tissue. * Be monitored for safety outcomes and any adverse events before, during, and after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 or older
Has indications for standard-of-care partial nephrectomy
Able to provide informed consent
Able to comply with study requirements
Disqualifiers
Known porphyria or hypersensitivity to porphyrins
Pregnant or breastfeeding women
AST or ALT > 2x upper limit of normal within 30 days prior to surgery
Participation in another investigational study within 30 days
Trial design
Design model
Single group
Treatments tested in this trial
5-Aminolevulinic acid Hydrochloride (Gliolan®)
DrugParticipants will receive a single oral dose of 5-aminolevulinic acid (20 mg/kg) approximately 2 to 4 hours prior to surgery. The goal is to evaluate the feasibility of using fluorescence cystoscopy with blue light to improve tumor detection and visualization during ureteroscopic resection of upper tract urothelial carcinoma. Other Name:
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: 5-ALA Fluorescence ImagingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Detection of tumor fluorescence using 5-ALA under blue light
Surgeons will assess whether renal tumors exhibit visible fluorescence under blue light following oral administration of 5-ALA (20 mg/kg). The presence or absence of fluorescence will be recorded for each lesion during partial nephrectomy.
Time frame
Intra-operativelySecondary outcomes
1
Incidence and severity of adverse events following 5-ALA administration
Incidence and severity (Grade 1-5, CTCAE v5.0) of adverse events related to 5-ALA administration (e.g., hypotension, GI effects, liver enzyme elevation, photosensitivity)
Time frame
Up to 30 days after interventionOther outcomes
1
Final tumor pathology
Presence or absence of residual tumor after resection
Time frame
Up to 2 weeks post-operativelySponsors and contacts
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Source ClinicalTrials.gov