Trial · NCT04620239
ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study
NCT04620239, Phase 3, Active not recruiting, Steba Biotech S.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study. Trials, record NCT04620239. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04620239
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study
- NCT number
- NCT04620239
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 89 participants, actual
- Lead sponsor
- Steba Biotech S.A.
- Conditions
- Transitional Cell Cancer of Renal Pelvis and Ureter
- Interventions
- padeliporfin VTP
- First posted
- 2020-11-06
- Last updated
- 2026-07-30
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of patients with absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter | 28 +/- 3 days post last treatment | Primary efficacy outcome is the absence of UTUC tumors in the entire ipsilateral calyces renal pelvis and ureter on endoscopic evaluation at the time of Primary Response Evaluation (PRE) (28 +/- 3 days post last treatment) during padeliporfin VTP induction treatment phase. This outcome will be determined dichotomously as either failure or success in achieving complete response. · Complete Response will be defined as absence of disease based on: * absence of visual tumor on endoscopy * no evidence of tumor on biopsy (if feasible) * negative urinary cytology by instrumented collection |
| Secondary | Duration of response at the entire ipsilateral kidney | 12 months post PRE | The duration of response at the entire ipsilateral kidney will be defined as absence of disease in the entire ipsilateral calyces, renal pelvis and ureter, based on: * instrumented cytology * visually on endoscopy * biopsy pathology (if feasible) as will be measured at the 12 months maintenance treatment visit post PRE |
| Secondary | Duration of response at the entire ipsilateral kidney | 3, 6, 9 months post PRE | The duration of response at the entire ipsilateral kidney will be defined as absence of disease in the entire ipsilateral calyces, renal pelvis and ureter, based on: * instrumented cytology * visually on endoscopy * biopsy pathology (if feasible) as will be measured at the 3, 6, 9 months maintenance treatment visits post PRE |
| Secondary | Duration of response at the Treatment Area of the ipsilateral kidney | 3, 6, 9, and 12 months post PRE | Duration of response at the Treatment Area of the ipsilateral kidney will be defined as absence of disease in the ipsilateral Treatment Area, based on: * instrumented cytology * visually on endoscopy * biopsy pathology (if feasible) as will be measured at the 3, 6, 9, and 12 months maintenance treatment visits post PRE |
| Secondary | Overall renal function | 6 and 12 months post PRE | Overall renal functional outcome will be measured at the 6 and 12 months maintenance treatment visits post PRE, and will be evaluated by comparing pre-treatment and 12-month estimated glomerular filtration rate (eGFR), calculated from serum creatinine levels, using the CKD-Epi method including: * Absolute change in eGFR as well as categories of CKD will be utilized based on KDIGO 2012 criteria * Description will include change in eGFR, change in CKD stage/risk category |
| Secondary | Kidney organ loss or preservation | 3, 6, 9, and 12 months post PRE | Kidney organ loss or preservation will be recorded at each maintenance treatment visit post PRE at 3, 6, 9, and 12 months Maintenance Treatment visits, and will describe the reasons for organ preservation or loss. A radical nephroureterectomy, nephron-sparing surgery for UTUC or ureterectomy will be considered as organ loss. |
| Secondary | Pathological evaluation of response | After at least one VTP treatment | PathologicalPathological evaluation of response will be performed in kidney tissue of patients that will undergo kidney surgical removal (kidney sparing, or radical nephroureterectomy) following at least one padeliporfin VTP treatment |
| Secondary | Patients with ureteral obstruction and/or ureteral stent | Baseline 12 months | Patients with existing ureteral obstruction and/or existing ureteral stent will be permitted with radiographic evidence of pre-existing obstruction documented, to demonstrate the site and degree of obstruction with retrograde pyelography at baseline (prior to treatment) and will be repeated and recorded at 12 months maintenance treatment visit (post treatment) which will further be supported with CT Urogram results at 12 months to demonstrate the site and degree of obstruction using standard nomenclature. |
| Secondary | Long Term follow-up Duration of the response | 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE | The duration of response in the ipsilateral kidney and treatment area will be defined as absence of disease, based on: * instrumented cytology * visually on endoscopy * biopsy pathology (if present and performed) |
| Secondary | Long Term follow-up Kidney organ loss or preservation | 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE | Kidney organ loss or preservation will be recorded and will describe the reasons for organ preservation or loss. A radical nephroureterectomy, nephron-sparing surgery for UTUC or ureterectomy will be considered as organ loss and a pathology report of the removed tissue will be recorded (if available or feasible) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04620239
GET https://conductscience.org/api/trials/v1/NCT04620239/registered