RetinoblastomaNCT04564521
Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.
A study testing Nitroglycerin and Normal saline in people with Retinoblastoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The primary objective of the study is to evaluate the effect of intravenously infused nitroglycerin on the incidence of the cardio-respiratory side effects during the intra-arterial chemotherapy for retinoblastoma in pediatric patients. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Retinoblastoma
- What is being tested?
- Nitroglycerin and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Sep 2020to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Retinoblastoma patients who need intra-arterial chemotherapy under general anesthesia
- Residual intra-arterial chemotherapy ≥ 2 times (cross-over design)
Who cannot join
- Respiratory disease causing a decrease in lung compliance
- Unstable vital sign, significant arrhythmia or hypotension, Shock
- Hypersensitivity or contraindication to nitroglycerin
- Increased intracranial pressure, Intracranial hemorrhage
- Recent use of PDE5 inhibitors (<24 hours after sildenafil or vardenafil; <48 hours after tadalafil)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jin-Tae Kim
Seoul
Jin-Tae Kim, MD. PhD, 82-2-2072-3295, kimjintae73@dreamwiz.com
About this study
Official title: The Effect of Nitroglycerin on the Incidence of Cardiorespiratory Side Effect During the Intra-arterial Chemotherapy in Pediatric Patients With Retinoblastoma: a Randomized, Double-blind, Placebo-controlled, Crossover Study
The primary objective of the study is to evaluate the effect of intravenously infused nitroglycerin on the incidence of the cardio-respiratory side effects during the intra-arterial chemotherapy for retinoblastoma in pediatric patients.
The intra-arterial chemotherapy at the ophthalmic artery is an important treatment option for retinoblastoma. However, the cardio-respiratory side effects (sudden onset of bradycardia, hypotension, a severe decrease in the compliance of lung, hypoxia) occasionally occurs during catheter manipulation in the ophthalmic artery. One of the purported mechanisms of cardio-respiratory side effects is vagal activation from the activation of trigeminal ganglion by afferent signals from the ophthalmic artery. Additionally, the chemotherapy agent can cause intra-arterial retinal precipitates. Therefore, it is expected that the dilation of the retinal artery may reduce the cardio-respiratory side effects and intra-arterial retinal precipitates.
The hypothesis of this study is that the intravenously infused nitroglycerin will increase the compliance of the ophthalmic and retinal artery and decrease vagal stimulation and cardio-respiratory side effects during catheter manipulation and chemotherapy agent infusion. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of intravenously infused nitroglycerin and saline on the incidence of the cardio-respiratory side effect in pediatric retinoblastoma patients undergoing intra-arterial chemotherapy. Prior to the procedure, each patient will be randomized into either the control-first arm, saline, or study-first arm, nitroglycerin.
- Conditions
- Retinoblastoma
- Being tested
- Nitroglycerin, Normal saline
- Keywords
- Intra-arterial chemotherapy, Cardio-respiratory side effects, Nitroglycerin
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitroglycerinDrug
Also called Intravenous nitroglycerin
Intravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy to reduce the cardio-respiratory side effects.
Normal salineDrug
Also called Intravenous normal saline
Intravenous normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy as an active comparator.
| Study group | Role | What they receive |
|---|---|---|
| Nitroglycerin | Experimental | Intravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy. Receives: Drug: Nitroglycerin |
| Normal saline | Active comparator | Normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
Bradycardia (< 80% of Baseline), Hypotension (< 80% of Baseline), Decrease in the lung compliance, Abnormal end-tidal CO2 curve, or Desaturation (SpO2 <95%)
Measured: During the intra-arterial chemotherapy (up to 4 hour)
Secondary outcomes (9)
The duration of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
Duration between the onset and the recovery from cardio-respiratory side effects.
Measured: During and after the intra-arterial chemotherapy (up to 48 hour)
The incidence of using vaso-active drugs (percent)
The incidence of using vaso-active drugs (e.g. vasopressor, inotropics)(percent)
Measured: During and after the intra-arterial chemotherapy (up to 48 hour)
The incidence of the side effect of nitroglycerin infusion (percent)
Hypotension (< 80% of baseline) after 10 minutes from nitroglycerin infusion, or allergic reaction, etc.
Measured: During the intra-arterial chemotherapy (up to 4 hour)
The concentration of inhaled sevoflurane (vol%)
The concentration of inhaled sevoflurane
Measured: During the intra-arterial chemotherapy (up to 4 hour)
The depth of anesthesia
The depth of anesthesia (bispectral index or patient sedation index, 0-100, 0 smaller score means deep anesthesia and larger score means awake state.)
Measured: During the intra-arterial chemotherapy (up to 4 hour)
Duration of anesthesia (min)
Duration of anesthesia
Measured: During the intra-arterial chemotherapy (up to 4 hour)
Total procedure time (min)
From ophthalmic artery selection to the end of intra-arterial injection.
Measured: During the intra-arterial chemotherapy (up to 4 hour)
The procedural satisfaction score of radiologist (1-3)
3 grades (1:poor, 2:fair, 3:good)
Measured: During the intra-arterial chemotherapy (up to 4 hour)
Incidence of the newly developed focal ischemia or infarct in retina photography(yes or no)
Incidence of the newly developed focal ischemia or infarct in retina photography(yes or no) on ophthalmology outpatient clinic after the intra-arterial chemotherapy assessed by pediatric ophthalmologist
Measured: After the intra-arterial chemotherapy (up to 6 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start28 Sep 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prior to the procedure, each patient will be randomized into either the saline-first arm or nitroglycerin-first arm. At the first intra-arterial chemotherapy after enrollment, saline or nitroglycerin is used according to the group allocation. At the second intra-arterial chemotherapy after enrollment, nitroglycerin is used for the saline-first arm, and saline is used for the nitroglycerin-first arm.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564521
- Sponsor's protocol ID
- 2006-108-1134
- Status last verified
- Nov 2023
- First submitted
- 2 Sep 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
FRAYSER R, HICKAM JB. EFFECT OF VASODILATOR DRUGS ON THE RETINAL BLOOD FLOW IN MAN. Arch Ophthalmol. 1965 May;73:640-2. doi: 10.1001/archopht.1965.00970030642008. No abstract available.
PubMed 14281979Yaster M, Simmons RS, Tolo VT, Pepple JM, Wetzel RC, Rogers MC. A comparison of nitroglycerin and nitroprusside for inducing hypotension in children: a double-blind study. Anesthesiology. 1986 Aug;65(2):175-9. doi: 10.1097/00000542-198608000-00008.
PubMed 3090906Dorner GT, Garhofer G, Kiss B, Polska E, Polak K, Riva CE, Schmetterer L. Nitric oxide regulates retinal vascular tone in humans. Am J Physiol Heart Circ Physiol. 2003 Aug;285(2):H631-6. doi: 10.1152/ajpheart.00111.2003. Epub 2003 May 15.
PubMed 12750062Munier FL, Beck-Popovic M, Balmer A, Gaillard MC, Bovey E, Binaghi S. Occurrence of sectoral choroidal occlusive vasculopathy and retinal arteriolar embolization after superselective ophthalmic artery chemotherapy for advanced intraocular retinoblastoma. Retina. 2011 Mar;31(3):566-73. doi: 10.1097/IAE.0b013e318203c101.
PubMed 21273941Shields CL, Bianciotto CG, Jabbour P, Ramasubramanian A, Lally SE, Griffin GC, Rosenwasser R, Shields JA. Intra-arterial chemotherapy for retinoblastoma: report No. 1, control of retinal tumors, subretinal seeds, and vitreous seeds. Arch Ophthalmol. 2011 Nov;129(11):1399-406. doi: 10.1001/archophthalmol.2011.150. Epub 2011 Jun 13.
PubMed 21670328Shields CL, Bianciotto CG, Jabbour P, Griffin GC, Ramasubramanian A, Rosenwasser R, Shields JA. Intra-arterial chemotherapy for retinoblastoma: report No. 2, treatment complications. Arch Ophthalmol. 2011 Nov;129(11):1407-15. doi: 10.1001/archophthalmol.2011.151. Epub 2011 Jun 13.
PubMed 21670326Fallaha N, Dubois J, Carret AS, Callejo SA, Hamel P, Superstein R. Real-time ophthalmoscopic findings of intraophthalmic artery chemotherapy in retinoblastoma. Arch Ophthalmol. 2012 Aug;130(8):1075-7. doi: 10.1001/archophthalmol.2012.180. No abstract available.
PubMed 22893086Cugati S, Varma DD, Chen CS, Lee AW. Treatment options for central retinal artery occlusion. Curr Treat Options Neurol. 2013 Feb;15(1):63-77. doi: 10.1007/s11940-012-0202-9.
PubMed 23070637Phillips TJ, McGuirk SP, Chahal HK, Kingston J, Robertson F, Brew S, Roebuck D, Hungerford JL, Herod J. Autonomic cardio-respiratory reflex reactions and superselective ophthalmic arterial chemotherapy for retinoblastoma. Paediatr Anaesth. 2013 Oct;23(10):940-5. doi: 10.1111/pan.12162. Epub 2013 May 13.
PubMed 23668238Kato MA, Green N, O'Connell K, Till SD, Kramer DJ, Al-Khelaifi M, Han JH, Pryor KO, Gobin YP, Proekt A. A retrospective analysis of severe intraoperative respiratory compliance changes during ophthalmic arterial chemosurgery for retinoblastoma. Paediatr Anaesth. 2015 Jun;25(6):595-602. doi: 10.1111/pan.12603. Epub 2015 Jan 7.
PubMed 25565164Scharoun JH, Han JH, Gobin YP. Anesthesia for Ophthalmic Artery Chemosurgery. Anesthesiology. 2017 Jan;126(1):165-172. doi: 10.1097/ALN.0000000000001381. No abstract available.
PubMed 27748655
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nitroglycerin on the Incidence of Cardiorespiratory Side Effect During the Intra-arterial Chemotherapy in Pediatric Patients With Retinoblastoma: a Randomized, Double-blind, Placebo-controlled, Crossover Study
- ClinicalTrials.gov ID
- NCT04564521
- Acronym / sponsor ID
- 2006-108-1134
- Conditions
- Retinoblastoma
- Keywords
- Intra-arterial chemotherapy, Cardio-respiratory side effects, Nitroglycerin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the effect of intravenously infused nitroglycerin on the incidence of the cardio-respiratory side effects during the intra-arterial chemotherapy for retinoblastoma in pediatric patients.
The intra-arterial chemotherapy at the ophthalmic artery is an important treatment option for retinoblastoma. However, the cardio-respiratory side effects (sudden onset of bradycardia, hypotension, a severe decrease in the compliance of lung, hypoxia) occasionally occurs during catheter manipulation in the ophthalmic artery. One of the purported mechanisms of cardio-respiratory side effects is vagal activation from the activation of trigeminal ganglion by afferent signals from the ophthalmic artery. Additionally, the chemotherapy agent can cause intra-arterial retinal precipitates. Therefore, it is expected that the dilation of the retinal artery may reduce the cardio-respiratory side effects and intra-arterial retinal precipitates.
The hypothesis of this study is that the intravenously infused nitroglycerin will increase the compliance of the ophthalmic and retinal artery and decrease vagal stimulation and cardio-respiratory side effects during catheter manipulation and chemotherapy agent infusion. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of intravenously infused nitroglycerin and saline on the incidence of the cardio-respiratory side effect in pediatric retinoblastoma patients undergoing intra-arterial chemotherapy. Prior to the procedure, each patient will be randomized into either the control-first arm, saline, or study-first arm, nitroglycerin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Prior to the procedure, each patient will be randomized into either the saline-first arm or nitroglycerin-first arm. At the first intra-arterial chemotherapy after enrollment, saline or nitroglycerin is used according to the group allocation. At the second intra-arterial chemotherapy after enrollment, nitroglycerin is used for the saline-first arm, and saline is used for the nitroglycerin-first arm.
| Arm | Type | Receives |
|---|---|---|
| Nitroglycerin | Experimental | Drug: NitroglycerinIntravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy. |
| Normal saline | Active comparator | Drug: Normal salineNormal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Retinoblastoma patients who need intra-arterial chemotherapy under general anesthesia
- Residual intra-arterial chemotherapy ≥ 2 times (cross-over design)
Key exclusion criteria (5 listed)
- Respiratory disease causing a decrease in lung compliance
- Unstable vital sign, significant arrhythmia or hypotension, Shock
- Hypersensitivity or contraindication to nitroglycerin
- Increased intracranial pressure, Intracranial hemorrhage
- Recent use of PDE5 inhibitors (<24 hours after sildenafil or vardenafil; <48 hours after tadalafil)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitroglycerinAlso: Intravenous nitroglycerinIntravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy to reduce the cardio-respiratory side effects. | Drug | Nitroglycerin |
| Normal salineAlso: Intravenous normal salineIntravenous normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy as an active comparator. | Drug | Normal saline |
Primary outcome
The incidence of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
Bradycardia (< 80% of Baseline), Hypotension (< 80% of Baseline), Decrease in the lung compliance, Abnormal end-tidal CO2 curve, or Desaturation (SpO2 <95%)
9 secondary outcomes
The duration of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent)
Time frame: During and after the intra-arterial chemotherapy (up to 48 hour)
The incidence of using vaso-active drugs (percent)
Time frame: During and after the intra-arterial chemotherapy (up to 48 hour)
The incidence of the side effect of nitroglycerin infusion (percent)
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
The concentration of inhaled sevoflurane (vol%)
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
The depth of anesthesia
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
Duration of anesthesia (min)
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
Total procedure time (min)
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
The procedural satisfaction score of radiologist (1-3)
Time frame: During the intra-arterial chemotherapy (up to 4 hour)
Incidence of the newly developed focal ischemia or infarct in retina photography(yes or no)
Time frame: After the intra-arterial chemotherapy (up to 6 month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 14281979FRAYSER R, HICKAM JB. EFFECT OF VASODILATOR DRUGS ON THE RETINAL BLOOD FLOW IN MAN. Arch Ophthalmol. 1965 May;73:640-2. doi: 10.1001/archopht.1965.00970030642008. No abstract available.
- Background: PubMed 3090906Yaster M, Simmons RS, Tolo VT, Pepple JM, Wetzel RC, Rogers MC. A comparison of nitroglycerin and nitroprusside for inducing hypotension in children: a double-blind study. Anesthesiology. 1986 Aug;65(2):175-9. doi: 10.1097/00000542-198608000-00008.
- Background: PubMed 12750062Dorner GT, Garhofer G, Kiss B, Polska E, Polak K, Riva CE, Schmetterer L. Nitric oxide regulates retinal vascular tone in humans. Am J Physiol Heart Circ Physiol. 2003 Aug;285(2):H631-6. doi: 10.1152/ajpheart.00111.2003. Epub 2003 May 15.
- Background: PubMed 21273941Munier FL, Beck-Popovic M, Balmer A, Gaillard MC, Bovey E, Binaghi S. Occurrence of sectoral choroidal occlusive vasculopathy and retinal arteriolar embolization after superselective ophthalmic artery chemotherapy for advanced intraocular retinoblastoma. Retina. 2011 Mar;31(3):566-73. doi: 10.1097/IAE.0b013e318203c101.
- Background: PubMed 21670328Shields CL, Bianciotto CG, Jabbour P, Ramasubramanian A, Lally SE, Griffin GC, Rosenwasser R, Shields JA. Intra-arterial chemotherapy for retinoblastoma: report No. 1, control of retinal tumors, subretinal seeds, and vitreous seeds. Arch Ophthalmol. 2011 Nov;129(11):1399-406. doi: 10.1001/archophthalmol.2011.150. Epub 2011 Jun 13.
- Background: PubMed 21670326Shields CL, Bianciotto CG, Jabbour P, Griffin GC, Ramasubramanian A, Rosenwasser R, Shields JA. Intra-arterial chemotherapy for retinoblastoma: report No. 2, treatment complications. Arch Ophthalmol. 2011 Nov;129(11):1407-15. doi: 10.1001/archophthalmol.2011.151. Epub 2011 Jun 13.
- Background: PubMed 22893086Fallaha N, Dubois J, Carret AS, Callejo SA, Hamel P, Superstein R. Real-time ophthalmoscopic findings of intraophthalmic artery chemotherapy in retinoblastoma. Arch Ophthalmol. 2012 Aug;130(8):1075-7. doi: 10.1001/archophthalmol.2012.180. No abstract available.
- Background: PubMed 23070637Cugati S, Varma DD, Chen CS, Lee AW. Treatment options for central retinal artery occlusion. Curr Treat Options Neurol. 2013 Feb;15(1):63-77. doi: 10.1007/s11940-012-0202-9.
- Background: PubMed 23668238Phillips TJ, McGuirk SP, Chahal HK, Kingston J, Robertson F, Brew S, Roebuck D, Hungerford JL, Herod J. Autonomic cardio-respiratory reflex reactions and superselective ophthalmic arterial chemotherapy for retinoblastoma. Paediatr Anaesth. 2013 Oct;23(10):940-5. doi: 10.1111/pan.12162. Epub 2013 May 13.
- Background: PubMed 25565164Kato MA, Green N, O'Connell K, Till SD, Kramer DJ, Al-Khelaifi M, Han JH, Pryor KO, Gobin YP, Proekt A. A retrospective analysis of severe intraoperative respiratory compliance changes during ophthalmic arterial chemosurgery for retinoblastoma. Paediatr Anaesth. 2015 Jun;25(6):595-602. doi: 10.1111/pan.12603. Epub 2015 Jan 7.
- Background: PubMed 27748655Scharoun JH, Han JH, Gobin YP. Anesthesia for Ophthalmic Artery Chemosurgery. Anesthesiology. 2017 Jan;126(1):165-172. doi: 10.1097/ALN.0000000000001381. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitroglycerin and Normal saline in people with Retinoblastoma, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young-Eun Jang, MD (82-2-2072-3664, na0ag2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of the cardio-respiratory side effects during ophthalmic artery selection and intra-arterial injection of chemotherapy agents. (percent) (time frame: During the intra-arterial chemotherapy (up to 4 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04564521, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.