A Phase 2 interventional study of 5-Aminolevulinic acid Hydrochloride (Gliolan®) in Kidney Cancers, sponsored by Henry Ford Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Henry Ford Health System · Phase 2, Interventional, and Diagnostic
Among 551 studies in Kidney Neoplasms with a site in United States — 67 open to participants now, 109 under way, 4 of them phase 3. Kidney Neoplasms · United States.
Among the 551 studies in Kidney Neoplasms with a site in United States, this one is the 378th largest by planned enrollment of the 443 interventional ones, is one of 17 that started in 2026, is one of 206 in phase 2, reaches primary completion later than 71 of the 103 other live ones, and was the 545th registered.
969 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's planned enrollment of 10 is below the median of 46 across 668 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →67 of the 551 studies in Kidney Neoplasms with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 173 Kidney Neoplasms studies recruiting now, 133 (77%) set no upper age limit and 15 (9%) stop at 75 or younger; 20 take children under 18; 24 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →551 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 17 started in 2026.
Median enrollment 37 across the 443 interventional studies, 350 across the 62 observational. Of the 410 that completed or were terminated, 156 (38%) have results posted.
154 of 551 have an industry lead sponsor. The 10 most frequent:
Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 26 (70%) have results posted.
Henry Ford Health System has 2 studies filed under Kidney Neoplasms — fewer than ten, so there is no comparison to draw.
42 of the studies in Kidney Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07814872Harvard Medical School (HMS and HSDM)A Preregistered Multi-Cohort Evaluation of the FATHOM AI System for Molecular Testing Prioritization to Support Clinical Trial Enrollment | 2026-11 |
| NCT06234605HiberCell, Inc.A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma | 2026-11 |
| NCT05969496University of Colorado, DenverNeoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus | 2026-11-01 |
| NCT00582621Memorial Sloan Kettering Cancer CenterAscertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders | 2026-12 |
| NCT06964958Dana-Farber Cancer Institute177LuPSMA in Renal Cell Carcinoma | 2026-12-01 |
Among the 551 studies in Kidney Neoplasms with a site in United States, from their registry updates:
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:
Participants will:
5-Aminolevulinic Acid (5-ALA), Gleolan, Kidney Cancer, Renal Cell Carcinoma, Partial Nephrectomy, Photodynamic Diagnosis (PDD), Fluorescence-Guided Surgery, Blue Light Imaging, Tumor Detection, Surgical Margins, Safety Profile, Adverse Events, Clinical Trial, Robotic Surgery, Pathology, Fluorescence Imaging, Renal Tumors, Pilot Study, Diagnostic Accuracy, Phase III Trial
This pilot clinical study aims to evaluate the safety and efficacy of 5-aminolevulinic acid (5-ALA; Gleolan) as a fluorescence-guided imaging agent for patients undergoing partial nephrectomy for suspected kidney cancer. Although 5-ALA is currently FDA-approved for visualization of high-grade gliomas during neurosurgery, emerging evidence suggests that it may also improve the detection of renal tumors through photodynamic diagnosis (PDD). The investigators hypothesize that oral administration of 5-ALA will cause kidney tumors to fluoresce under blue light, allowing surgeons to more easily identify tumors and assess resection margins while maintaining a favorable safety profile with minimal adverse events.
The study plans to enroll 10 adult patients aged 18 to 75 years who have kidney tumors amenable to standard-of-care partial nephrectomy. Eligible participants must have good performance status (ECOG 0-1) and adequate renal, hepatic, and hematologic function. Patients with significant cardiovascular disease, active liver disease, poorly controlled infections, pregnancy, porphyria-related hypersensitivity, or other major comorbidities will be excluded.
After informed consent is obtained, patients will undergo baseline laboratory testing including a comprehensive metabolic panel (CMP), liver function tests, lactate dehydrogenase (LDH), and γ-glutamyl transferase (GGT). On the day of surgery, participants will receive 20 mg/kg of oral 5-ALA dissolved in water approximately 2-4 hours before the procedure. Patients will be monitored preoperatively for known side effects such as nausea, vomiting, hypotension, and photosensitivity.
The surgical procedure will follow standard robotic partial nephrectomy techniques, with the addition of fluorescence imaging. Surgeons will first visualize the exposed tumor under white light and capture images. The operative field will then be examined using a specially modified blue-light imaging system to determine whether the tumor exhibits fluorescence. Following tumor excision under standard white light, the resection bed will again be examined with blue light to identify any residual fluorescent tissue that may indicate remaining tumor. If concerning fluorescence is observed, additional tissue margins may be resected and sent separately for pathological examination.
The primary outcomes include the ability of blue-light fluorescence imaging to detect kidney tumors and assist in evaluating residual disease. Investigators will compare tumor detection under white light versus blue light and calculate sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) using final surgical pathology as the gold standard. Receiver operating characteristic (ROC) curve analysis will be used to compare diagnostic performance between imaging modalities.
This proof-of-concept study seeks to determine whether 5-ALA fluorescence-guided surgery can improve intraoperative visualization of kidney tumors while maintaining an acceptable safety profile. Positive findings could support larger studies and potentially justify advancement to a Phase III clinical trial investigating fluorescence-guided kidney cancer surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single oral dose of 5-aminolevulinic acid (5-ALA, Gleolan) 2-4 hours prior to ureteroscopic tumor resection. Blue light endoscopy will be used intraoperatively to assess tumor fluorescence and aid in visualization and resection.
Drug: 5-Aminolevulinic acid Hydrochloride (Gliolan®)
Participants 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:
Also known as: Gleolan, 5-ALA
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-operatively
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 intervention
Final tumor pathology
Presence or absence of residual tumor after resection
Time frame: Up to 2 weeks post-operatively
Plan to share: No — This is a single-site, investigator-initiated feasibility study funded through an internal philanthropic research grant. Individual participant data will not be shared, as there is no formal data-sharing infrastructure in place and the study is not intended to support regulatory submissions or external data analysis.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
Of 64 non-industry phase 2 interventional studies under Kidney Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 112. This study's planned 15 months is below that.
Counting every sponsor, half of 74 studies reached it within 67 months; a quarter within 36 and three quarters within 112.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Oral Aminolevulinic Acid Hydrochloride