hexaminolevulinate Clinical Trials (2026): 14 Studies for Bladder Cancer & Cervical Dysplasia
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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14 hexaminolevulinate clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 8 indications (including Bladder Cancer & Cervical Dysplasia) and 5,760 total planned enrollment. 3 Phase 3 hexaminolevulinate trials and 1 Phase 2, 2 Phase 4 are listed. 2 hexaminolevulinate clinical trials are actively recruiting at 21 U.S. sites across 15 states. Most recent activity: NCT05962541 (Dec 2031).
Where to Participate: All hexaminolevulinate Trial Sites in the U.S. (21 sites across 15 states)
Every actively recruiting hexaminolevulinatetrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AL | The University of Alabama at Birmingham | Birmingham35294 | NCT02660645 | Map |
| AZ | Mayo Clinic | Phoenix85054 | NCT02660645 | Map |
| CA | University of California Los Angeles | Los Angeles90095 | NCT02660645 | Map |
| CA | USC/Norris Comprehensive Cancer Center | Los Angeles90033 | NCT02660645 | Map |
| CA | VA Palo Alto Health Care System | Palo Alto94304 | NCT02660645 | Map |
| CA | University of California, San Francisco | San Francisco94143 | NCT02660645 | Map |
| DC | Sibley Memorial Hospital | Washington D.C.20016 | NCT02660645 | Map |
| GA | Emory University School of Medicine | Atlanta30097 | NCT02660645 | Map |
| IL | Northwestern University | Chicago60611 | NCT02660645 | Map |
| IL | Northshore University Health System | Evanston60201 | NCT02660645 | Map |
| IN | Indiana University School of Medicine | Indianapolis46202 | NCT02660645 | Map |
| KS | University of Kansas Medical Center | Kansas City66160 | NCT02660645 | Map |
| MD | Johns Hopkins Medicine | Baltimore21224 | NCT02660645 | Map |
| MN | University of Minnesota | Minneapolis55455 | NCT02660645 | Map |
| NY | NYU Langone's Perlmutter Cancer Center | New York10016 | NCT02660645 | Map |
| OH | Ohio State University | Columbus43210 | NCT02660645 | Map |
| OH | Ohio State University Wexner Medical Center | Columbus43210 | NCT02660645 | Map |
| SC | Lexington Medical Center | West Columbia29169 | NCT02660645 | Map |
| TX | UT Southwestern | Dallas75390 | NCT02660645 | Map |
| TX | Michael E. DeBakey VA Medical Center | Houston77030 | NCT02660645 | Map |
| WA | University of Washington Medicine | Seattle98195 | NCT02660645 | Map |
hexaminolevulinate clinical trials at a glance: phase × recruitment status
| Phase | recruiting | completed | terminated | withdrawn | Total |
|---|---|---|---|---|---|
| P1 | 1 | 1 | |||
| P1/P2 | 2 | 1 | 3 | ||
| P2 | 1 | 1 | |||
| P2/P3 | 1 | 1 | |||
| P3 | 3 | 3 | |||
| P4 | 1 | 1 | 2 | ||
| N/A | 1 | 2 | 3 |
Recruiting hexaminolevulinate clinical trials (2)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT05962541 | CUT-lessVesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) | P4 | Non-muscle-invasive Bladder Cancer | 327 | Dec 2025 |
| NCT02660645 | BLCCRBlue Light Cystoscopy With Cysview® Registry | — | Bladder Cancer | 4,400 | Apr 2014 |
hexaminolevulinate clinical trials by indication
Bladder Cancer (7)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02660645 | BLCCR | N/A | recruiting | Blue Light Cystoscopy With Cysview® Registry |
| NCT05600322 | — | P3 | completed | Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer |
| NCT03058705 | — | N/A | completed | Near Infrared Fluorescence Imaging for Bladder Cancer Detection |
| NCT02560584 | — | P3 | completed | A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting |
| NCT00785694 | — | P4 | withdrawn | Recurrence of Bladder Cancer After Transurethral Resection With Hexvix |
| NCT00634621 | — | N/A | completed | Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer |
| NCT00052637 | — | P3 | completed | Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer |
Non-muscle-invasive Bladder Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05962541 | CUT-less | P4 | recruiting | Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) |
Genital Lichen Planus (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01282515 | GELP | P2/P3 | completed | Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT |
Pharmacokinetics (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01050309 | HAL | P1 | completed | An Open-label, Single-dose, Three Period Study to Determine the Pharmacokinetic Parameters of Hexaminolevulinate (HAL) Hydrochloride After Vaginal, Enema and Intravenous Administration of Healthy Female Volunteers |
Colon Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01344902 | HAL | P1/P2 | terminated | An Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon |
Cervical Intraepithelial Neoplasia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00708942 | HAL | P2 | terminated | Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1 |
Cervical Dysplasia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00369018 | — | P1/P2 | completed | A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions. |
Colorectal Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00285701 | — | P1/P2 | completed | Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study |
hexaminolevulinate pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| CUT-less | NCT05962541 | P4 | recruiting | Non-muscle-invasive Bladder Cancer | 327 | PMID 39397266 |
| HAL | NCT00708942 | P2 | terminated | Cervical Intraepithelial Neoplasia | 83 | — |
Terminated and withdrawn hexaminolevulinate trials (3)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT00708942terminatedHexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1
- NCT00785694withdrawnRecurrence of Bladder Cancer After Transurethral Resection With Hexvix
- NCT01344902terminatedAn Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon
All hexaminolevulinate trials (14)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT05962541 | CUT-less | Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) | P4 | recruiting | 327 | University of Roma La Sapienza | Dec 2025 |
| NCT02660645 | BLCCR | Blue Light Cystoscopy With Cysview® Registry | — | recruiting | 4,400 | Photocure | Apr 2014 |
| NCT05600322 | Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer | P3 | completed | 158 | Photocure | Nov 2022 | |
| NCT03058705 | Near Infrared Fluorescence Imaging for Bladder Cancer Detection | N/A | completed | 10 | Edward Messing | Nov 2017 | |
| NCT02560584 | A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting | P3 | completed | 304 | Photocure | Oct 2015 | |
| NCT01282515 | GELP | Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT | P2/P3 | completed | 40 | Oslo University Hospital | Aug 2011 |
| NCT00708942 | HAL | Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1 | P2 | terminated | 83 | Photocure | Jan 2009 |
| NCT00785694 | Recurrence of Bladder Cancer After Transurethral Resection With Hexvix | P4 | withdrawn | 0 | GE Healthcare | Dec 2008 | |
| NCT00634621 | Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer | — | completed | 283 | GE Healthcare | Feb 2008 | |
| NCT01050309 | HAL | An Open-label, Single-dose, Three Period Study to Determine the Pharmacokinetic Parameters of Hexaminolevulinate (HAL) Hydrochloride After Vaginal, Enema and Intravenous Administration of Healthy Female Volunteers | P1 | completed | 8 | Photocure | Nov 2009 |
| NCT00369018 | A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions. | P1/P2 | completed | 96 | Photocure | Aug 2006 | |
| NCT01344902 | HAL | An Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon | P1/P2 | terminated | 13 | Photocure | Feb 2009 |
| NCT00285701 | Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study | P1/P2 | completed | 38 | Photocure | Jul 2006 | |
| NCT00052637 | Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer | P3 | completed | 0 | Photocure | Sep 2001 |
hexaminolevulinate clinical trials: frequently asked questions
- How many hexaminolevulinate clinical trials are there?
- 14 hexaminolevulinate clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 2 are actively recruiting participants. 9 are marked completed.
- Are hexaminolevulinate clinical trials recruiting in 2026?
- Yes — 2 hexaminolevulinate trials are actively recruiting in 2026, with 21 U.S. sites across 15 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is hexaminolevulinate being studied for?
- hexaminolevulinate is being studied for Bladder Cancer, Cervical Dysplasia, Cervical Intraepithelial Neoplasia, Colon Cancer, Colorectal Cancer and 5 more. The trials are grouped by indication on this page.
- What phase is hexaminolevulinate in?
- hexaminolevulinate clinical trials span 2 Phase 4, 3 Phase 3, 1 Phase 2, 1 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors hexaminolevulinate clinical trials?
- The lead sponsor across the most hexaminolevulinate trials is Photocure, with 4 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming hexaminolevulinateas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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