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.

StateFacilityCityTrialMap
ALThe University of Alabama at BirminghamBirmingham35294NCT02660645Map
AZMayo ClinicPhoenix85054NCT02660645Map
CAUniversity of California Los AngelesLos Angeles90095NCT02660645Map
CAUSC/Norris Comprehensive Cancer CenterLos Angeles90033NCT02660645Map
CAVA Palo Alto Health Care SystemPalo Alto94304NCT02660645Map
CAUniversity of California, San FranciscoSan Francisco94143NCT02660645Map
DCSibley Memorial HospitalWashington D.C.20016NCT02660645Map
GAEmory University School of MedicineAtlanta30097NCT02660645Map
ILNorthwestern UniversityChicago60611NCT02660645Map
ILNorthshore University Health SystemEvanston60201NCT02660645Map
INIndiana University School of MedicineIndianapolis46202NCT02660645Map
KSUniversity of Kansas Medical CenterKansas City66160NCT02660645Map
MDJohns Hopkins MedicineBaltimore21224NCT02660645Map
MNUniversity of MinnesotaMinneapolis55455NCT02660645Map
NYNYU Langone's Perlmutter Cancer CenterNew York10016NCT02660645Map
OHOhio State UniversityColumbus43210NCT02660645Map
OHOhio State University Wexner Medical CenterColumbus43210NCT02660645Map
SCLexington Medical CenterWest Columbia29169NCT02660645Map
TXUT SouthwesternDallas75390NCT02660645Map
TXMichael E. DeBakey VA Medical CenterHouston77030NCT02660645Map
WAUniversity of Washington MedicineSeattle98195NCT02660645Map

hexaminolevulinate clinical trials at a glance: phase × recruitment status

PhaserecruitingcompletedterminatedwithdrawnTotal
P111
P1/P2213
P211
P2/P311
P333
P4112
N/A123

Recruiting hexaminolevulinate clinical trials (2)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT05962541CUT-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)P4Non-muscle-invasive Bladder Cancer327Dec 2025
NCT02660645BLCCRBlue Light Cystoscopy With Cysview® RegistryBladder Cancer4,400Apr 2014

hexaminolevulinate clinical trials by indication

Bladder Cancer (7)

NCTAcronymPhaseStatusTitle
NCT02660645BLCCRN/ArecruitingBlue Light Cystoscopy With Cysview® Registry
NCT05600322P3completedComparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer
NCT03058705N/AcompletedNear Infrared Fluorescence Imaging for Bladder Cancer Detection
NCT02560584P3completedA Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting
NCT00785694P4withdrawnRecurrence of Bladder Cancer After Transurethral Resection With Hexvix
NCT00634621N/AcompletedEffectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer
NCT00052637P3completedCystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer

Non-muscle-invasive Bladder Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05962541CUT-lessP4recruitingVesical 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)

NCTAcronymPhaseStatusTitle
NCT01282515GELPP2/P3completedTreatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT

Pharmacokinetics (1)

NCTAcronymPhaseStatusTitle
NCT01050309HALP1completedAn 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)

NCTAcronymPhaseStatusTitle
NCT01344902HALP1/P2terminatedAn 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)

NCTAcronymPhaseStatusTitle
NCT00708942HALP2terminatedHexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

Cervical Dysplasia (1)

NCTAcronymPhaseStatusTitle
NCT00369018P1/P2completedA Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.

Colorectal Cancer (1)

NCTAcronymPhaseStatusTitle
NCT00285701P1/P2completedEarly 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.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
CUT-lessNCT05962541P4recruitingNon-muscle-invasive Bladder Cancer327PMID 39397266
HALNCT00708942P2terminatedCervical Intraepithelial Neoplasia83

Terminated and withdrawn hexaminolevulinate trials (3)

Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.

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 IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT05962541CUT-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)P4recruiting327University of Roma La SapienzaDec 2025
NCT02660645BLCCRBlue Light Cystoscopy With Cysview® Registryrecruiting4,400PhotocureApr 2014
NCT05600322Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder CancerP3completed158PhotocureNov 2022
NCT03058705Near Infrared Fluorescence Imaging for Bladder Cancer DetectionN/Acompleted10Edward MessingNov 2017
NCT02560584A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance SettingP3completed304PhotocureOct 2015
NCT01282515GELPTreatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDTP2/P3completed40Oslo University HospitalAug 2011
NCT00708942HALHexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1P2terminated83PhotocureJan 2009
NCT00785694Recurrence of Bladder Cancer After Transurethral Resection With HexvixP4withdrawn0GE HealthcareDec 2008
NCT00634621Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancercompleted283GE HealthcareFeb 2008
NCT01050309HALAn 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 VolunteersP1completed8PhotocureNov 2009
NCT00369018A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.P1/P2completed96PhotocureAug 2006
NCT01344902HALAn Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the ColonP1/P2terminated13PhotocureFeb 2009
NCT00285701Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding StudyP1/P2completed38PhotocureJul 2006
NCT00052637Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder CancerP3completed0PhotocureSep 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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