A Phase 1 interventional study of Chlorine Dioxide Injection 2% in Solid Tumor and Neoplasms, sponsored by SunGlow Innovations LLC. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by SunGlow Innovations LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety of injecting a 2% chlorine dioxide solution directly into tumors in adults with advanced solid tumors, and to determine whether the injected solution stays within the tumor under real-time imaging guidance. Chlorine dioxide reacts with and destroys the tissue it contacts and is consumed locally within about a minute. Up to about 50 participants will receive up to 4 treatment sessions per lesion, about one week apart, and will be followed for 12 months.
Chlorine Dioxide Injection 2% is a ready-to-use solution of chlorine dioxide in 0.9% sodium chloride, injected into the tumor under ultrasound or CT guidance or under direct vision. Each target lesion receives about 30% (25-35%) of its volume per session (about 10% at high-risk locations). The total volume per session is limited to 50 mL and may be increased to 100 mL after review by an independent Data Safety Monitoring Board. The first 6 participants form a safety lead-in, in which plasma chlorite, chlorate and chloride are measured. Efficacy is assessed on contrast-enhanced CT 7 to 28 days after the last session and during follow-up.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with SunGlow Innovations LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Image-guided or direct-vision intratumoral injection of about 30% (25-35%) of lesion volume per lesion (about 10% at high-risk locations); total volume per session up to 50 mL, increased to 100 mL after DSMB review; up to 4 sessions per lesion, about 7 days apart, within 60 days.
Drug: Chlorine Dioxide Injection 2%
Ready-to-use 2% (w/w) chlorine dioxide in 0.9% sodium chloride, injected directly into the tumor under ultrasound or CT guidance or under direct vision.
Number of participants with dose-limiting toxicities
Dose-limiting toxicities as defined in the protocol (Section 8), assessed after each treatment session.
Time frame: 28 days after each treatment session
Number of participants with treatment-emergent adverse events
Any adverse event graded by CTCAE v5.0, from the first treatment session onward.
Time frame: From first treatment session up to 12 months
Number of participants with grade 3 or higher adverse events
Adverse events of CTCAE v5.0 grade 3 or higher.
Time frame: From first treatment session up to 12 months
Number of participants with serious adverse events
Serious adverse events as defined in 21 CFR 312.32.
Time frame: From first treatment session up to 12 months
Number of participants with adverse events related to study drug
Adverse events assessed by the investigator as possibly, probably or definitely related to Chlorine Dioxide Injection 2%.
Time frame: From first treatment session up to 12 months
Percentage of deliveries with solution outside the lesion boundary
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.
Time frame: During each treatment session
Percentage of deliveries terminated by a mandatory stopping rule
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.
Time frame: During each treatment session
Number of participants with non-target tissue injury
Injury to tissue outside the treatment zone attributable to delivered solution, assessed clinically and on imaging.
Time frame: During each treatment session and up to 28 days after
Lesion-level complete non-viable radiological response rate
Percentage of target lesions with no residual viable tumor on contrast-enhanced imaging.
Time frame: 7 to 28 days after the last treatment session
Patient-level complete non-viable radiological response rate
Percentage of participants with complete non-viable response of all lesions, among participants in whom all visible lesions were injected.
Time frame: 7 to 28 days after the last treatment session
Necrosis percentage per target lesion
Necrosis proportion = 1 - (residual viable volume / baseline lesion volume), expressed as a percentage, per target lesion.
Time frame: 7 to 28 days after the last treatment session
Number of target lesions by necrosis grade
Target lesions categorized by necrosis grade: complete; 90% or more; 50% to less than 90%; less than 50%.
Time frame: 7 to 28 days after the last treatment session
Maintenance of complete non-viable response
Percentage of target lesions with complete non-viable response that remain without residual viable tumor on imaging.
Time frame: 3, 6 and 12 months after the first treatment session
Objective response by RECIST 1.1
Percentage of participants with complete or partial response of target lesions according to RECIST 1.1.
Time frame: Up to 12 months
Pain score on the numeric rating scale
Patient-reported pain on an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable).
Time frame: Before and 24 hours, 7 days and 28 days after each treatment session
Number of participants with cessation of tumor bleeding
Among participants with a bleeding target lesion at baseline, the number in whom bleeding stopped.
Time frame: 24 hours, 7 days and 28 days after each treatment session
Maximum plasma chlorite concentration
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.
Time frame: Before and up to 24 hours after the first treatment session
Maximum plasma chlorate concentration
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.
Time frame: Before and up to 24 hours after the first treatment session
Change in plasma chloride concentration
Change from pre-treatment in plasma chloride concentration (mmol/L) in safety lead-in participants, interpreted against the physiological background.
Time frame: Before and up to 24 hours after the first treatment session
Maximum methemoglobin level
Maximum blood methemoglobin level (% of total hemoglobin) measured by co-oximetry.
Time frame: Before and up to 24 hours after each treatment session
Change in plasma free hemoglobin
Change from pre-treatment in plasma free hemoglobin (mg/dL).
Time frame: Before and up to 24 hours after each treatment session
Change in serum haptoglobin
Change from pre-treatment in serum haptoglobin (mg/dL).
Time frame: Before and up to 24 hours after each treatment session
Change in serum lactate dehydrogenase
Change from pre-treatment in serum lactate dehydrogenase (U/L).
Time frame: Before and up to 24 hours after each treatment session
Change in total bilirubin
Change from pre-treatment in total bilirubin (mg/dL).
Time frame: Before and up to 24 hours after each treatment session
Local control rate with retreatment permitted
Percentage of treated target lesions without viable tumor at the treated site, with retreatment of residual or recurrent tumor permitted as specified in the protocol. Retreatment is not counted as treatment failure.
Time frame: 3, 6 and 12 months after the first treatment session
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Mar 2028, 12 months later.
Of 677 industry-sponsored phase 1 interventional studies under Neoplasms, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 61. This study's planned 12 months is below that.
Counting every sponsor, half of 903 studies reached it within 40 months; a quarter within 23 and three quarters within 64.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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