Kidney CancersPhase 2NCT07828704
Photodynamic Diagnosis of Kidney Cancer Using Fluorescence Endoscopy and Oral 5-ALA
A Phase 2 study testing 5-Aminolevulinic acid Hydrochloride (Gliolan®) in people with Kidney Cancers, run by Henry Ford Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Cancers
- What is being tested?
- 5-Aminolevulinic acid Hydrochloride (Gliolan®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 or older
- Has indications for standard-of-care partial nephrectomy
- Able to provide informed consent
- Able to comply with study requirements
Who cannot join
- 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
- Known allergy or contraindication to 5-ALA or its components
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Johar Raza, MD, 313-585-0578, jraza1@hfhs.org
About this study
Official title: A Phase II Study on Photodynamic Diagnosis of Urological Cancer in the Kidney Using Fluorescence Endoscopy With Cystoscopy and Ureteroscopy With 5-ALA
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Kidney Cancers
- Being tested
- 5-Aminolevulinic acid Hydrochloride (Gliolan®)
- Keywords
- 5-Aminolevulinic Acid (5-ALA), Gleolan, Kidney Cancer, Partial Nephrectomy, Photodynamic Diagnosis, Fluorescence-Guided Surgery, Renal Cell Carcinoma, Minimally Invasive Surgery, Urologic Oncology, Blue Light
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Aminolevulinic acid Hydrochloride (Gliolan®)Drug
Also called Gleolan, 5-ALA
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:
| Study group | Role | What they receive |
|---|---|---|
| 5-ALA Fluorescence Imaging | Experimental | 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. Receives: Drug: 5-Aminolevulinic acid Hydrochloride (Gliolan®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra-operatively
Secondary 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)
Measured: Up to 30 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kidney CancersStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johar Raza, Henry Ford Health System
- Investigators
- Johar Raza, MD, Principal investigator, Henry Ford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828704
- Sponsor's protocol ID
- HFH-IRB18380
- Other IDs
- IRB18380
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Yamamoto S, Fukuhara H, Karashima T, Inoue K. Real-world experience with 5-aminolevulinic acid for the photodynamic diagnosis of bladder cancer: Diagnostic accuracy and safety. Photodiagnosis Photodyn Ther. 2020 Dec;32:101999. doi: 10.1016/j.pdpdt.2020.101999. Epub 2020 Sep 10.
PubMed 32920180Hoda MR, Popken G. Surgical outcomes of fluorescence-guided laparoscopic partial nephrectomy using 5-aminolevulinic acid-induced protoporphyrin IX. J Surg Res. 2009 Jun 15;154(2):220-5. doi: 10.1016/j.jss.2008.12.027. Epub 2009 Jan 14.
PubMed 19375717Fukuhara H, Kurabayashi A, Furihata M, Setuda S, Takahashi K, Murakami K, Tanaka T, Inoue K. 5-aminolevulinic acid-mediated photodynamic diagnosis using fluorescence ureterorenoscopy for urinary upper tract urothelial carcinoma approximately Preliminary prospective single centre trial approximately . Photodiagnosis Photodyn Ther. 2020 Mar;29:101617. doi: 10.1016/j.pdpdt.2019.101617. Epub 2019 Dec 16.
PubMed 31857216Yoshida T, Setsuda S, Ishizuka M, Inoue T, Kinoshita H, Matsuda T. Photodynamic Diagnosis with Oral 5-Aminolevulinic Acid for Upper Urinary Tract Carcinoma: A Prospective Clinical Trial. J Endourol. 2020 Apr;34(4):509-515. doi: 10.1089/end.2019.0725. Epub 2020 Mar 31.
PubMed 31964177Nakai Y, Inoue K, Tsuzuki T, Shimamoto T, Shuin T, Nagao K, Matsuyama H, Oyama M, Furuse H, Ozono S, Miyake M, Fujimoto K. Oral 5-aminolevulinic acid-mediated photodynamic diagnosis using fluorescence cystoscopy for non-muscle-invasive bladder cancer: A multicenter phase III study. Int J Urol. 2018 Aug;25(8):723-729. doi: 10.1111/iju.13718. Epub 2018 Jul 12.
PubMed 29999205Taoka R, Matsuoka Y, Yamasaki M, Kani N, Honda T, Harada S, Tohi Y, Kato T, Okazoe H, Tsunemori H, Ueda N, Sugimoto M. Photodynamic diagnosis-assisted transurethral resection using oral 5-aminolevulinic acid decreases residual cancer and improves recurrence-free survival in patients with non-muscle-invasive bladder cancer. Photodiagnosis Photodyn Ther. 2022 Jun;38:102838. doi: 10.1016/j.pdpdt.2022.102838. Epub 2022 Apr 4.
PubMed 35381368
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study on Photodynamic Diagnosis of Urological Cancer in the Kidney Using Fluorescence Endoscopy With Cystoscopy and Ureteroscopy With 5-ALA
- ClinicalTrials.gov ID
- NCT07828704
- Acronym / sponsor ID
- HFH-IRB18380
- Conditions
- Kidney Cancers
- Keywords
- 5-Aminolevulinic Acid (5-ALA), Gleolan, Kidney Cancer, Partial Nephrectomy, Photodynamic Diagnosis, Fluorescence-Guided Surgery, Renal Cell Carcinoma, Minimally Invasive Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5-ALA Fluorescence Imaging | Experimental | Drug: 5-Aminolevulinic acid Hydrochloride (Gliolan®)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 or older
- Has indications for standard-of-care partial nephrectomy
- Able to provide informed consent
- Able to comply with study requirements
Key exclusion criteria (5 listed)
- 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
- Known allergy or contraindication to 5-ALA or its components
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-Aminolevulinic acid Hydrochloride (Gliolan®)Also: Gleolan, 5-ALAParticipants 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: | Drug | 5-ALA Fluorescence Imaging |
Primary outcome
Detection of tumor fluorescence using 5-ALA under blue light
Time frame: Intra-operatively
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.
1 secondary outcome
Incidence and severity of adverse events following 5-ALA administration
Time frame: Up to 30 days after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 32920180Yamamoto S, Fukuhara H, Karashima T, Inoue K. Real-world experience with 5-aminolevulinic acid for the photodynamic diagnosis of bladder cancer: Diagnostic accuracy and safety. Photodiagnosis Photodyn Ther. 2020 Dec;32:101999. doi: 10.1016/j.pdpdt.2020.101999. Epub 2020 Sep 10.
- Background: PubMed 19375717Hoda MR, Popken G. Surgical outcomes of fluorescence-guided laparoscopic partial nephrectomy using 5-aminolevulinic acid-induced protoporphyrin IX. J Surg Res. 2009 Jun 15;154(2):220-5. doi: 10.1016/j.jss.2008.12.027. Epub 2009 Jan 14.
- Background: PubMed 31857216Fukuhara H, Kurabayashi A, Furihata M, Setuda S, Takahashi K, Murakami K, Tanaka T, Inoue K. 5-aminolevulinic acid-mediated photodynamic diagnosis using fluorescence ureterorenoscopy for urinary upper tract urothelial carcinoma approximately Preliminary prospective single centre trial approximately . Photodiagnosis Photodyn Ther. 2020 Mar;29:101617. doi: 10.1016/j.pdpdt.2019.101617. Epub 2019 Dec 16.
- Background: PubMed 31964177Yoshida T, Setsuda S, Ishizuka M, Inoue T, Kinoshita H, Matsuda T. Photodynamic Diagnosis with Oral 5-Aminolevulinic Acid for Upper Urinary Tract Carcinoma: A Prospective Clinical Trial. J Endourol. 2020 Apr;34(4):509-515. doi: 10.1089/end.2019.0725. Epub 2020 Mar 31.
- Background: PubMed 29999205Nakai Y, Inoue K, Tsuzuki T, Shimamoto T, Shuin T, Nagao K, Matsuyama H, Oyama M, Furuse H, Ozono S, Miyake M, Fujimoto K. Oral 5-aminolevulinic acid-mediated photodynamic diagnosis using fluorescence cystoscopy for non-muscle-invasive bladder cancer: A multicenter phase III study. Int J Urol. 2018 Aug;25(8):723-729. doi: 10.1111/iju.13718. Epub 2018 Jul 12.
- Background: PubMed 35381368Taoka R, Matsuoka Y, Yamasaki M, Kani N, Honda T, Harada S, Tohi Y, Kato T, Okazoe H, Tsunemori H, Ueda N, Sugimoto M. Photodynamic diagnosis-assisted transurethral resection using oral 5-aminolevulinic acid decreases residual cancer and improves recurrence-free survival in patients with non-muscle-invasive bladder cancer. Photodiagnosis Photodyn Ther. 2022 Jun;38:102838. doi: 10.1016/j.pdpdt.2022.102838. Epub 2022 Apr 4.
- Primary FDA Approval CitationLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johar Raza, MD principal investigator
Henry Ford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-Aminolevulinic acid Hydrochloride (Gliolan®) in people with Kidney Cancers, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peace Deh, MD (313-916-7699, pdeh1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of tumor fluorescence using 5-ALA under blue light (time frame: Intra-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07828704, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.