Trial · NCT07911293
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with dose-limiting toxicities | 28 days after each treatment session | Dose-limiting toxicities as defined in the protocol (Section 8), assessed after each treatment session. |
| Primary | Number of participants with treatment-emergent adverse events | From first treatment session up to 12 months | Any adverse event graded by CTCAE v5.0, from the first treatment session onward. |
| Primary | Number of participants with grade 3 or higher adverse events | From first treatment session up to 12 months | Adverse events of CTCAE v5.0 grade 3 or higher. |
| Primary | Number of participants with serious adverse events | From first treatment session up to 12 months | Serious adverse events as defined in 21 CFR 312.32. |
| Primary | Number of participants with adverse events related to study drug | From first treatment session up to 12 months | Adverse events assessed by the investigator as possibly, probably or definitely related to Chlorine Dioxide Injection 2%. |
| Primary | Percentage of deliveries with solution outside the lesion boundary | During each treatment session | Number of deliveries in which intraprocedural imaging shows delivered solution outside the target lesion boundary, divided by the total number of deliveries, expressed as a percentage. |
| Primary | Percentage of deliveries terminated by a mandatory stopping rule | During each treatment session | Number of deliveries terminated by a stopping rule defined in the protocol (Section 7.6), divided by the total number of deliveries, expressed as a percentage. |
| Primary | Number of participants with non-target tissue injury | During each treatment session and up to 28 days after | Injury to tissue outside the treatment zone attributable to delivered solution, assessed clinically and on imaging. |
| Secondary | Lesion-level complete non-viable radiological response rate | 7 to 28 days after the last treatment session | Percentage of target lesions with no residual viable tumor on contrast-enhanced imaging. |
| Secondary | Patient-level complete non-viable radiological response rate | 7 to 28 days after the last treatment session | Percentage of participants with complete non-viable response of all lesions, among participants in whom all visible lesions were injected. |
| Secondary | Necrosis percentage per target lesion | 7 to 28 days after the last treatment session | Necrosis proportion = 1 - (residual viable volume / baseline lesion volume), expressed as a percentage, per target lesion. |
| Secondary | Number of target lesions by necrosis grade | 7 to 28 days after the last treatment session | Target lesions categorized by necrosis grade: complete; 90% or more; 50% to less than 90%; less than 50%. |
| Secondary | Maintenance of complete non-viable response | 3, 6 and 12 months after the first treatment session | Percentage of target lesions with complete non-viable response that remain without residual viable tumor on imaging. |
| Secondary | Objective response by RECIST 1.1 | Up to 12 months | Percentage of participants with complete or partial response of target lesions according to RECIST 1.1. |
| Secondary | Pain score on the numeric rating scale | Before and 24 hours, 7 days and 28 days after each treatment session | Patient-reported pain on an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable). |
| Secondary | Number of participants with cessation of tumor bleeding | 24 hours, 7 days and 28 days after each treatment session | Among participants with a bleeding target lesion at baseline, the number in whom bleeding stopped. |
| Secondary | Maximum plasma chlorite concentration | Before and up to 24 hours after the first treatment session | Maximum observed plasma chlorite concentration measured by validated ion chromatography in safety lead-in participants. Values below the limit of quantification are reported as such. |
| Secondary | Maximum plasma chlorate concentration | Before and up to 24 hours after the first treatment session | Maximum observed plasma chlorate concentration measured by validated ion chromatography in safety lead-in participants. Values below the limit of quantification are reported as such. |
| Secondary | Change in plasma chloride concentration | Before and up to 24 hours after the first treatment session | Change from pre-treatment in plasma chloride concentration (mmol/L) in safety lead-in participants, interpreted against the physiological background. |
| Secondary | Maximum methemoglobin level | Before and up to 24 hours after each treatment session | Maximum blood methemoglobin level (% of total hemoglobin) measured by co-oximetry. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT07911293/registered